Many Americans turn to the latest big idea to lose weight — fad diets, fitness crazes, dodgy herbs and pills, bariatric surgery, just to name a few. They’re rarely the magic solution people dream of.

Now a wave of startups offer access to a new category of drugs coupled with intensive behavioral coaching online. But already concerns are emerging.

These startups, spurred by hundreds of millions of dollars in funding from blue-chip venture capital firms, have signed up well over 100,000 patients and could reach millions more. These patients pay hundreds, if not thousands, of dollars to access new drugs, called GLP-1 agonists, along with online coaching to encourage healthy habits.

The startups initially positioned themselves in lofty terms. “This is the last weight loss program you’ll try,” said a 2020 marketing analysis by startup Calibrate Health, in messaging designed to reach one of its target demographics, the “Working Mom.” (Company spokesperson Michelle Wellington said the document does not reflect Calibrate’s current marketing strategy.)

But while doctors and patients are intrigued by the new model, some customers complain online that reality is short of the buildup: They say they got canned advice and unresponsive clinicians — and some report they couldn’t get the newest drugs.

Calibrate Health, a New York City-based startup, it had served 20,000 people. Another startup, , headquartered in San Francisco, has served 160,000 patients since July 2020. costs patients nearly $1,600 a year, not counting the price of drugs, which can hit nearly $1,500 monthly without insurance, according to drug price savings site . (Insurers reimburse for GLP-1 agonists in limited circumstances, patients said.) Found offers a six-month plan for nearly $600, a company spokesperson said. (That price includes generic drugs, but not the newer GLP-1 agonists, like Wegovy.)

The two companies are beneficiaries of over $200 million in combined venture funding, according to by , a repository of venture capital investments. The firms say they’re on the vanguard of weight care, both citing the influence of biology and other scientific factors as key ingredients to their approaches.

There’s potentially a big market for these startups. Just , according to the Centers for Disease Control and Prevention, driving up their risk for cardiovascular conditions and Type 2 diabetes. Effective medical treatments are elusive and hard to access.

Centers that provide this specialty care “are overwhelmed,” said Dr. , an obesity medicine specialist at Massachusetts General in Boston, a teaching hospital affiliated with Harvard. Her own clinic has a waitlist of 3,000.

Stanford, who said she has advised several of these telemedicine startups, is bullish on their potential.

, director of obesity medicine at the Cleveland Clinic, said the startups can offer care with less judgment and stigma than in-person peers. They’re also more convenient.

Butsch, who learned about the model through consultancies, patients, and colleagues, wonders whether the startups are operating “to strategically find which patients respond to which drug.” He said they should coordinate well with behavioral specialists, as antidepressants or other medications may be driving weight gain. “Obesity is a complex disease and requires treatments that match its complexity,” he said. “I think programs that do not have a multidisciplinary team are less comprehensive and, in the long term, less effective.”

The startups market a two-pronged product: first, the new class of GLP-1 agonists. While these medications are effective at provoking weight loss, Wegovy, one of two in this class specifically approved for this purpose, is in due to manufacturing difficulties, according to its maker, Novo Nordisk. can be prescribed off-label. But doctors generally aren’t familiar with the medications, Stanford said. In theory, the startups can bridge some of those gaps: They offer more specialized, knowledgeable clinicians.

Then there’s the other prong: behavioral changes. The companies use televisits and online messaging with nutritionists or coaches to help patients incorporate new diet and exercise habits. The weight loss figures achieved by participants in clinical trials for the new drugs — up to 15% of body mass — were tied to such changes, according to .

Social media sites are bursting with these startups’ ads, everywhere from podcasts to Instagram. A search of Meta’s ad library finds 40,000 ads on Facebook and Instagram between the two firms.

The ads complement people’s own postings on social media: Numerous Facebook groups are devoted to the new type of drugs — some even focused on helping patients manage side effects, like changes in their bowel movements. The buzz is quantifiable: On TikTok, mentions of the new GLP-1 agonists tripled from last June to this June, according to an analysis by investment bankers at Morgan Stanley.

There’s now a feverish, expectant appetite for these medications among the startups’ clientele. Patients often complained that their friends had obtained a drug they weren’t offered, recalled Alexandra Coults, a former pharmacist consultant for Found. Coults said patients may have perceived some sort of bait-and-switch when in reality clinical reasons — like drug contraindications — guide prescribing decisions.

Patient expectations influence care, Coults said. Customers came in with ideas shaped by the culture of fad diets and New Year’s resolutions, she said. “Quite a few people would sign up for one month and not continue.”

In interviews with KHN and in online complaints, patients also questioned the quality of care they received. Some said intake — which began by filling out a form and proceeded to an online visit with a doctor — was perfunctory. Once medication began, they said, requests for counseling about side effects were slow to be answered.

Jess Garrant, a Found patient, recalled that after she was prescribed zonisamide, a generic anticonvulsant that has shown some ability to help with weight loss, she felt “absolutely weird.”

“I was up all night and my thoughts were racing,” . She developed sores in her mouth.

She sought advice and help from Found physicians, but their replies, she told KHN, “weren’t quick.” Nonemergency communications are routed through the company’s portal.

It took a week to complete a switch of medications and have a new prescription arrive at her home, she said. Meanwhile, she said, she went to an urgent care clinic for the mouth sores.

Found frequently prescribes generic medications — often off-label — rather than just the new GLP-1 agonists, company executives said in an interview. Found said older generics like zonisamide are more accessible than the GLP-1 agonists advertised on social media and their own website. Both Butsch and Stanford said they’ve prescribed zonisamide successfully. Butsch said ramping up dosage rapidly can increase the risk of side effects.

But Dr. Kim Boyd, chief medical officer of competitor Calibrate, said the older drugs “just haven’t worked.”

Patients of both companies have critiqued online and in interviews the startups’ behavioral care — which experts across the board maintain is integral to successful weight loss treatment. But some patients felt they simply had canned advice.

Other patients said they had ups and downs with their coaches. Dana Crom, an attorney, said she had gone through many coaches with Calibrate. Some were good, effective cheerleaders; others, not so good. But when kinks in the program arose, she said, the coach wasn’t able to help her navigate them. While the coach can report trouble with medications or the app, it appears those reports are no more effective than messages sent through the portal, Crom said.

And what about when her yearlong subscription ends? Crom said she’d consider continuing with Calibrate.

Relationships with coaches, given the need to change behavior, are a critical element of the business models. Patients’ results depend “on how adherent they are to lifestyle changes,” said Found’s chief medical officer, .

While the startups offer care to a larger geographic footprint, it’s not clear whether the demographics of their patient populations are different from those of the traditional bricks-and-mortar model. Calibrate’s patients are overwhelmingly white; over 8 in 10 have at least an undergraduate degree; over 8 in 10 are women, according to the company.

And its earlier marketing strategies reflected that. The September 2020 “segmentation” document laid out three types of customers the company could hope to attract: perimenopausal or menopausal women, with income ranging from $75,000 to $150,000 a year; working mothers, with a similar income; and “men.”

Isabelle Kenyon, Calibrate’s CEO, said the company now hopes to expand its reach to partner with large employers, and that will help diversify its patients.

Patients will need to be convinced that the model — more affordable, more accessible — works for them. For her part, Garrant, who no longer is using Found, reflected on her experience, writing in her blog post that she was hoping for more follow-up and a more personal approach. “I don’t think it’s a helpful way to lose weight,” she said.

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For years, people with Type 1 diabetes have worn continuous glucose monitors, or CGMs, to track blood sugar spikes and make sure they’re getting enough insulin. CGMs are small patches with tiny needles for sensors that prick the skin and are generally worn on the stomach or back of the arm.

Now, a wave of tech companies are selling CGMs to the public. That made me curious: Would this work for me? What would I learn?

The devices, linked to apps with personalized analytics and meal planning advice, are being touted as a behavior-changing path to better health and athletic performance, consistent energy, and overcoming the dreaded weight-loss-weight-gain cycle once and for all.

For people without diabetes, tracking the glycemic response to meals can pinpoint which foods significantly spike blood sugar, leading to a subsequent blood sugar crash and then lethargy. That excess insulin and glucose in the blood stream can also signal to the body to put the surplus sugar in storage, causing weight gain.

The new-age, health-monitoring ecosystem sprawls well beyond CGMs, leaving traditional step counters in the dust. A tracker in the form of made by Ultrahuman monitors movement and sleep — and can be paired with a glucose-monitoring patch. ’s wearable technology, which tracks respiratory rate, blood oxygen, and other health metrics, can . Another device, the Lumen, to determine whether the user is burning carbs or fat.

The market for this technology is huge, from Olympic athletes to office workers looking to avoid the post-lunch lull. The nation has long been in the throes of what is often referred to as an obesity epidemic. From 2017 through 2021, 26% of Americans, on average, said they were “seriously trying to lose weight,” and more than half said they would like to, according to . And about 96 million U.S. adults have prediabetes, increasing their risk of developing chronic diseases like Type 2 diabetes and heart disease, . Prediabetes affects people who are both lean and overweight, though obesity does .

Investors are taking note. Nearly $3.5 billion poured into U.S. weight loss digital health startups from 2020 through the first half of 2022, according to an analysis by venture fund Rock Health for KHN. CGM startups , , , and have raised more than $140 million in funding collectively, according to company funding database Crunchbase.

There’s plenty of hype about all the data they deliver.

and in podcasts often feature active 20-somethings. They promise unique insights into how individual bodies react to food, exercise, and sleep in real time by homing in on metabolic health and how well users keep their glucose levels in check. “,” says CGM-based company Signos. A promo for Lumen shares: “You hold in your lungs the secret to sustainable weight loss.”

But even as people in the field have seen “significant” results from incorporating these tools into weight loss programs, they acknowledge that no single approach seems able to do it all. For instance, Eric Kusher, a doctor of chiropractic who runs an intensive weight loss program at , said he still relies on the human element, too, falling back on his staff’s dietary advice, not the meal guidance provided by apps.

The reality layer is also important, said Dr. , a senior scholar at Stanford University’s Clinical Excellence Research Center. “If you’re a harried mother trying to care for three kids and hold down a job, you’re not going to have time to monitor and create the perfect green shake,” he said. “You’re going to buy the dollar meal because that’s easier and cheaper for your kids — and then you’re going to eat whatever they don’t eat.”

For weight loss and inflammation flare-ups, Sarah Schacht, a 42-year-old government innovation consultant from Seattle, has tried all kinds of health tech, including Levels and Lumen. The generalized “eat less, move more” — — wasn’t working for her. The Levels app lets the user log meals, exercise, and other notable events; combines the information with CGM data; and then offers insights and advice on how users can foster gentler glucose curves. Since starting Levels a year and a half ago, she has lost 5 pounds, her weight has stabilized, and the inflammatory responses have gone down. But her body has not dramatically changed, she said.

“I get the feeling that the few success stories I’ve seen, people who have radically changed their bodies, spend a lot of time on their eating strategy,” Schacht said. “Not everyone has that mental capacity, time, or budget.”

These devices aren’t covered by insurance, so, with related subscriptions for the data, costs can be hundreds of dollars annually. There is also scant research on CGMs’ effectiveness in improving the health of people without diabetes, let alone prompting weight loss. Without firm results, many health care providers . Some experts also worry that the constant stream of data could prompt .

, co-director of the Center for Weight Management and Wellness at Brigham and Women’s Hospital in Boston, said she does not see the use of an expensive CGM for someone who doesn’t have diabetes, especially with new weight loss drugs within reach. Those drugs, of course, will also carry a hefty price tag.

“It’s hard work losing 10 pounds,” Apovian said. “A CGM is going to wipe out your money so you can’t join a gym.”

Most of the people who have insulin resistance and metabolic disease tend to be lower income and minorities who can’t afford CGMs, said , co-owner of BioCoach. has FDA clearance for its glucose and ketone meter, which checks glucose levels and tests for ketones in the blood — . Its more traditional finger-prick technology keeps the subscription price down to $30 a month while still letting people without diabetes learn about their metabolic health, though not with continuous data. The company has amassed a , where Delgado and others raise awareness about sugary foods and diabetes.

The CGM startups generally offer one of two CGMs: Abbott’s FreeStyle Libre, which is cheaper and requires a manual scan of the sensor by a smartphone, or the Bluetooth-connected Dexcom G6, which updates to a smartphone automatically. The monitors are provided to people without diabetes through “off-label” prescriptions because the FDA has not yet approved the tools for the general population.

CGMs are , so companies are betting that the FDA will approve them to be available on drugstore shelves in the U.S. That should drive down the prices of the sensors, which can cost hundreds of dollars.

But already says it can use artificial intelligence to predict a person’s glucose levels after a user wears a CGM for two weeks. The algorithm, backed by and a library of food nutrition data, can then predict the person’s glucose response to thousands of foods before the user decides what to eat, not after. This brings the cost down, essentially creating a virtual CGM, said , CEO of January. The company is rolling out a new version of its app this fall.

Across the board, the startups are largely working through the kinks, some still conducting the research to back up their marketed claims and taking different approaches to using the technology. A common theme for the startups, though, is going direct-to-consumer first — aiming for people who can afford the concept — before eventually seeking coverage from insurers, said , founder and general partner of Rock Health Capital.

The companies are also trying to add novel twists to how their apps use the data to reach health and weight-loss goals, each with libraries of informational blogs, lessons, and activities. They range in cost from hundreds of dollars annually to , with charges covering the price of the hardware, the subscription for wraparound services, and in some cases nutritionist support. The companies are banking on the idea that customers will sign on for the long term.

Taking a more wraparound approach, NutriSense has leaned heavily into building out an 80-person nutrition team that works closely with customers, according to Kara Collier, the company’s vice president of health.

Signos, which focuses on weight loss, uses artificial intelligence to set a “weight loss range” for customers depending on their general glucose ranges and level of fitness.

Out of curiosity, this reporter stuck a CGM on the back of her arm for 10 days and signed up for the Levels app. At first, the metrics were jarring. As a person without diabetes, I had never reckoned with my glucose levels before.

Then I started recognizing patterns that made sense: Drinking beer always spiked my glucose, but a bagel after a long morning walk kept my blood sugar relatively stable. Avocado toast or eggs for breakfast were better alternatives, though. And a salad with chickpeas, tomatoes, and turkey for lunch earned top marks.

Digesting data alongside every meal certainly made me think harder about what I ate and when I exercised. But it also felt like a lot of extra homework.

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Excitement is building about a new generation of drugs that tout the ability to help adults with excess weight shed more pounds than older drugs on the market.

Some patients, obesity medicine specialists say, are experiencing decreases in blood pressure, better-managed diabetes, less joint pain, and better sleep from these newfound treatments.

The newer drugs, which are repurposed diabetes drugs, “are showing weight loss unlike any other medications we’ve had in the past,” said , a psychologist and registered dietitian in the Bariatric & Metabolic Institute at the Cleveland Clinic.

Yet for him and other experts, the thrill is tempered.

That’s because no single drug is a magic solution by itself, and it’s possible many patients will need to take the to maintain results. On top of that, the newest treatments are often very costly and often not covered by insurance.

The five-figure annual costs of the new medications are also raising concern about access for patients and what widespread use could mean for the nation’s overall health care tab.

Evaluating the trade-offs — weighing the value of better health and possibly fewer complications of obesity down the road against the upfront drug costs — will increasingly come into play as insurers, employers, government programs, and others who pay health care bills consider which treatments to cover.

“If you pay too much for a drug, everyone’s health insurance goes up. Then people drop off health insurance because they can’t afford it,” so providing the drug might cause more harm to the system than not, , chief medical officer for the Institute for Clinical and Economic Review, or ICER, a nonprofit group that reviews medical evidence to evaluate treatments for effectiveness and cost.

Many commercial insurers currently limit coverage to only some of the drugs currently available, or require patients to meet certain thresholds for coverage — often pegging it to a controversial measure called “body mass index,” a ratio of height to weight. Medicare specifically bars coverage for obesity medications or drugs for “anorexia, weight loss or weight gain,” although it pays for bariatric surgery. Coverage in other government programs varies. Legislation that would allow medication coverage in Medicare — the — has not made progress despite being reintroduced every congressional session since 2012.

As insurers view the cost of treatments with concern, manufacturers see a potential financial bonanza. Morgan Stanley analysts recently said “obesity is the new hypertension” and predicted industry revenue from U.S. obesity drug sales could rise from its current $1.6 billion to $31.5 billion by 2030.

It’s easy to see how they could predict that startling number based simply on potential demand. In the U.S., 42% of adults are considered obese, up from 33% a decade earlier. Health problems sometimes linked to weight, such as and , are also on the rise.

Even losing 5% of body weight can provide health benefits, say experts. Some of the new drugs, which can help curb hunger, aid some patients in surpassing that marker.

Wegovy, which is a higher dose of the self-injectable diabetes drug Ozempic, helped patients lose an average of 15% of their body weight over 68 weeks during the clinical trial that led to its FDA approval last year. After stopping the drug, many patients followed in an extension of the trial gained back weight, which is not uncommon with almost any diet medication. Wegovy has spent much of the year in due to manufacturing issues. It can cost around $1,300 a month.

Another injectable drug, still in final clinical trials but by the FDA, could spur even greater weight loss, in the 20% range, according to Eli Lilly, its manufacturer. Both drugs mimic a hormone called glucagon-like peptide 1, which can signal the brain in ways that make .

The average weight loss from both, however, puts the drugs within striking distance of results seen following surgical procedures, offering another option for patients and physicians.

But will the range of old and new prescription medical products — with even more in the development pipeline — be the answer to America’s weight problem?

A big maybe, say experts. For one thing, the medications and devices don’t work for everyone and vary in effectiveness.

Plenity is a prime example. With a price tag of $98 a month, it’s considered by the FDA to be a device and requires a prescription. During clinical trials, about 40% of people who tried it failed to lose weight. But among the other 60%, the average weight loss was 10.2% of body weight over 24 weeks when coupled with diet and exercise.

That average puts it in line with other, older, prescription weight loss medications, which often show when taken over a year.

While it is true that weight loss drugs — both old- and new-generation — don’t work for everyone, there’s enough variation among individuals that “even the older drugs work really well for some people,” said Rind at ICER.

But it’s too soon — especially for the newer drugs — to know how long the results can last and what patients will weigh five or 10 years out, he said.

Still, advocates argue that insurers should cover treatments for weight issues as they cover those for cancer or chronic conditions like high blood pressure. Paying for such treatment could be good both for the patient and insurers’ bottom lines, they argue. Over time, insurers may pay less for people who lose weight and then avoid other health complications, but such financial gains to the health system could take years or even decades to accrue.

Financial benefits for drugmakers are mixed so far. Novo Nordisk, the maker of Wegovy and Ozempic, saw obesity care sales grow 110% in the first half of the year, driven by Wegovy, but its stock price remained flat and even dipped in September. But Lilly, which won approval for , that may soon also get the green light for weight loss, saw its September stock prices 34% higher than last September’s.

Some employers and insurers who pay health care bills are also asking whether the drugs are priced fairly.

ICER recently , comparing four weight loss medications. Two, Wegovy and Saxenda, are new-generation treatments, both made by Novo based on an existing injection diabetes drug. The other two — phentermine/topiramate, sold by Vivus as Qsymia, and bupropion/naltrexone, sold as Contrave by Currax Pharmaceuticals — are older therapies based on pill combinations.

Results were mixed, according to a report released in August, which will be finalized soon after public comments are evaluated and incorporated.

Wegovy showed greater weight loss compared with other treatments. But Qsymia also helped patients lose a substantial amount of weight, Rind said. That older drug combination has a net cost, after manufacturer discounts, of about $1,465 annually in the second year of use, compared with Wegovy, which had a net cost of $13,618 in that second year, the report said. Many patients may be prescribed weight loss drugs for years.

With such numbers, Wegovy did not meet the group’s cost-effectiveness threshold.

“It’s a great drug, but it’s about twice as expensive as it should be” when its health benefits are weighed against its cost and potential to drive up overall medical spending and health premiums, said Rind.

Don’t expect costs to go down anytime soon, though, even as other new drugs are poised to hit the market.

Lilly, for instance, has yet to reveal what Mounjaro will cost if it clears clinical trials for use as a weight loss medication. But a hint comes from its $974-a-month price as a diabetes treatment — an amount similar to that of rival diabetes drug Ozempic, Wegovy’s precursor.

Novo charges more for Wegovy than Ozempic, although the weight loss version does include more of the active ingredient. It’s possible Lilly will take a page out of that playbook and also charge more for its weight loss version of Mounjaro.

, a professor in the department of nutrition sciences at the University of Alabama-Birmingham, predicts insurance coverage will improve over time.

“It’s undeniable now that you can achieve substantial weight loss if you stay on medications — and reduce the complications of obesity,” Garvey said. “It will be hard for health insurers and payers to deny.”

One thing the new focus on medication treatment may promote, most of the experts said, is to temper the bias and stigma that has long dogged patients who are overweight or have obesity.

“The group with the highest level of weight bias is physicians,” said , an obesity medicine specialist and the equity director of the endocrine division at Massachusetts General Hospital. “Imagine how you feel if you have a physician who tells you your value is based on your weight.”

Rind sees the new, more effective therapies as another way to help dispel the notion that patients “aren’t trying hard enough.”

“It’s become more and more obvious over the years that obesity is a medical issue, not a lifestyle choice,” Rind said. “We’ve been waiting for drugs like this for a very long time.”

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That work, done in the 1830s by , appealed to life insurance companies, which created “ideal” weight tables after the turn of the century. By the 1970s and 1980s, the measurement, now dubbed body mass index, was adopted to screen for and track obesity.

Now it’s everywhere, using an equation — — to categorize patients as overweight, underweight, or at a “healthy weight.” It’s appealingly simple, with a scale that designates adults who score between 18.5 and 24.9 as within a healthy range.

But critics — and they are widespread these days — say it was never meant as a health diagnostic tool. “BMI does not come from science or medicine,” said , an obesity medicine specialist and the equity director of the endocrine division at Massachusetts General Hospital.

She and other experts said BMI can be useful in tracking population-wide weight trends, but it falls short by failing to account for differences among ethnic groups, and it can target some people, including athletes, as overweight or obese because it does not distinguish between muscle mass and fat.

Still, BMI has become a standard tool to determine who is most at risk of the health consequences of excess weight — and who qualifies for often-expensive treatments. Despite the heavy debate surrounding BMI, is that people who are overweight or obese are at greater risk for a host of health problems, including diabetes, liver problems, osteoarthritis, high blood pressure, sleep apnea, and cardiovascular problems.

The BMI measure is commonly included in the prescribing directions for weight loss drugs. Some of the newest and most effective drugs, such as Wegovy, limit use to patients who have a BMI of 30 or higher — the obesity threshold — or a lower level of 27, if the patient has at least one weight-related medical condition, such as diabetes. Doctors can prescribe the medications to patients who don’t meet those label requirements, but insurers might not cover any of the cost.

While most insurers, including Medicare, of bariatric surgery for weight loss, they might require a patient to have a BMI of at least 35, along with other health conditions, such as high blood pressure or diabetes, to qualify.

With medications, it can be even trickier. does not cover most prescription weight loss drugs, although it will cover behavioral health treatments and obesity screening. Coverage for weight loss medications varies among private health plans.

“It’s very frustrating because everything we do in obesity medicine is based on these cutoffs,” said Stanford.

Critics say that BMI can err on both ends of the scale, mistakenly labeling some larger people as unhealthy and people who weigh less as healthy, even if they need medical treatment.

For eating disorders, insurers often use BMI to make coverage decisions and can limit treatment to only those who rank as underweight, missing others who need help, said , communications director for , a nonprofit that helps patients get treatment, whether they are uninsured or have been denied care through their health plan.

“Because there’s such a focus on BMI numbers, we are missing people who could have gotten help earlier, even if they are at a medium BMI,” Nangia said. “If they are not underweight, they are not taken seriously, and their behaviors are overlooked.”

Stanford said she, too, often battles insurance companies over who qualifies for overweight treatment based on BMI definitions, especially some of the newer, pricier weight loss medications, which can cost more than $1,500 a month.

“I’ve had patients doing well on medication and their BMI gets below a certain level, and then the insurance company wants to take them off the medication,” Stanford said, adding she challenges those decisions. “Sometimes I win, sometimes I lose.”

While perhaps useful as a screening tool, BMI alone is not a good arbiter of health, said Stanford and many other experts.

“The health of a person with a 29 BMI might be worse than one with a 50 if that person with the 29 has high cholesterol, diabetes, sleep apnea, or a laundry list of things,” said Stanford, “while the person with a 50 just has high blood pressure. Which one is sicker? I would say the person with more metabolic disease.”

Additionally, BMI can for tall people and underestimate it for short ones, experts say. And it does not account for .

Case in point: “Black women who are between 31 and 33 BMI tend to have better health status even at that above-30 level” than other women and men, Stanford said.

Meanwhile, , including the long-running Nurses’ Health Study, found that Asian people had a greater risk of developing diabetes as they gained weight, compared with whites and certain ethnic groups. As a result, countries such as China and Japan have set lower BMI overweight and obesity thresholds for people of Asian descent.

Experts generally agree that BMI should not be the only measure to assess patients’ health and weight.

“It does have limitations,” said , a psychologist and registered dietitian at Cleveland Clinic’s Bariatric and Metabolic Institute. “It doesn’t tell us anything about the difference between muscle and fat weight,” he said, noting that many athletes might score in the overweight category, or even land in the obesity range due to muscle bulk.

Instead of relying on BMI, physicians and patients should consider other factors in the weight equation. One is being aware of where weight is distributed. Studies have shown that health risks increase if a person carries excess weight in the midsection. “If someone has thick legs and most of their weight is in the lower body, it’s not nearly as harmful as if they have it around their midsection, especially their organs,” said Creel.

Stanford agrees, saying midsection weight “is a much better proxy for health than BMI itself,” with the potential for developing conditions like fatty liver disease or diabetes “directly correlated with waist size.”

Patients and their doctors can use a simple tool to assess this risk: . Measuring just above the hipbone, women should stay at 35 inches or less; men, 40 inches or less, researchers advise.

New ways to define and diagnose obesity are in the works, including a panel of international experts convened by the prestigious Lancet Commission, said Stanford, a member of the group. Any new criteria ultimately approved might not only help inform physicians and patients, but also affect insurance coverage and public health interventions.

Stanford has also studied a way to recalibrate BMI to reflect gender and ethnic differences. It incorporates various groups’ risk factors for conditions such as diabetes, high blood pressure, and high cholesterol.

Based on her research, she said, the BMI cutoff would trend lower for men as well as Hispanic and white women. It would shift to slightly higher cutoffs for Black women. (Hispanic people can be of any race or combination of races.)

“We do not plan to eliminate the BMI, but we plan to devise other strategies to evaluate the health associated with weight status,” said Stanford.

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Those are pushing a product named Plenity as a potential liberation from dieters’ woes. It’s a $98-a-month weight loss treatment that looks like a drug: Patients take three capsules twice a day. But it isn’t a drug. And its success in racking up lost pounds, on average, is modest.

Plenity is FDA-approved as a device, one that contains sugar-sized grains of a plant-based, absorbent hydrogel. Each grain swells to 100 times its size, cumulatively filling about a quarter of a person’s stomach. The three capsules containing them must be taken with two cups of water at least 20 minutes before eating. The gel is not absorbed and eventually exits the body in stool.

The treatment is also generally not covered by insurance.

“We thought we would price it low enough that most consumers can pay out-of-pocket,” said Dr. Harry Leider, chief medical officer and executive vice president of Gelesis, the maker of Plenity.

Although far less costly than some other prescription weight loss treatments, it still “isn’t affordable for someone in the low-income bracket,” said Jena Shaw Tronieri, an assistant professor and director of clinical services at the University of Pennsylvania’s Center for Weight and Eating Disorders.

Plenity is designed to help patients who want to eat less, and taking it to consuming a big salad before lunch and dinner, without the actual raw vegetables.

It joins a growing selection of prescription weight loss and obesity treatments, from old-school oral medications that are often low-cost generics to far pricier brand-name injectable diabetes drugs newly repurposed as weight loss treatments. Results varied widely among trial participants; 59% of those who got Plenity lost at least 5% of their body weight, although the rest did not meet that threshold.

Plenity, whose active ingredient is a form of cellulose, embraces a strategy that has been used for decades by some people: to feel full before eating a main meal, thus reducing the calories they take in. Studies have shown that “if you fill up on broth-based soup or vegetables before a meal, you will feel fuller and eat less,” said Tronieri. She noted that filling up with water doesn’t produce the same satiating effect.

Still, some patients say that they “hate vegetables” and that “capsules are a lot easier,” said Dr. Christina Nguyen, medical director of obesity medicine at Northeast Georgia Health System. She is not affiliated with Gelesis but has been prescribing Plenity since its soft launch in late 2020.

So far, Gelesis credits the marketing campaign with helping it pick up in the first three months of the year, adding $7.5 million in revenue, although the company still lost money in the first quarter.

So where does this latest treatment fit as a potential weight loss tool for the more than 70% of American adults who are overweight or obese?

“I’m glad to see it on the market, but I tend to want more weight loss in patients than what I’m looking at with this device,” said W. Timothy Garvey, professor at the University of Alabama at Birmingham and director of the university’s Diabetes Research Center.

Gelesis reported that participants in its clinical trial who used Plenity lost on average 6.4% of body weight — above the 5% that many physicians say is a good target threshold. For a 200-pound person, that would equal almost 13 pounds. Still, that’s only a bit better than the 4.4% weight loss, on average, that people given a placebo in the experienced. All 436 participants were put on diets that averaged 300 calories a day less than they needed to maintain their weight.

Nguyen said she tells her patients they must change their eating and exercise habits or Plenity won’t work. “You have to be realistic and set expectations,” she said. “What I’ve seen with Plenity is weight loss of about 5%.”

She noted it has relatively few side effects — mainly gastrointestinal, such as bloating, nausea, constipation, or flatulence — and the FDA has approved it for use in people with lower body mass index numbers than required for many other prescription products.

Plenity’s average weight loss is comparable to or below that of some other oral medications and is far less than that of the much more expensive new additions to the market such as Novo Nordisk’s Wegovy, a once-a-week injection that costs $1,300 a month. Wegovy helped patients lose nearly 15% of their body weight over 17 months, on average, according to clinical trials. In April, an injectable drug it is testing helped patients achieve an average weight loss of 22.5%. More details were released .

“We don’t see Wegovy as a competitor,” said Leider, of Gelesis.

Nor does Leider view the weight loss products available without a prescription as competitors.

Leider said Gelesis sought FDA prescription approval for the treatment, rather than over-the-counter status, because “there’s a whole wall of nutritional supplements and products” and “we felt it was absolutely important to do the study and prove it scientifically works.” Down the road, “once we’ve built the brand,” Gelesis could seek over-the-counter status, he added.

As with other treatments, weight loss with Plenity can vary widely, he noted. Study data shows 27% of those given the treatment were considered “super responders,” losing an average of 14% of their weight. Patients with diabetes or prediabetes may respond better than those with normal blood sugar levels.

Still, it didn’t work for 40% of participants in the trial.

“If you take it for two months and you’re not losing weight, it may not be the therapy for you,” Leider said.

Patients can request Plenity from their physicians. In a move aimed at setting it apart from other treatments, Gelesis offers potential patients another choice: skipping an in-office visit entirely by requesting the treatment online. It has partnered with Ro, a direct-to-patient platform, which provides its network of affiliated physicians for online health assessments and delivers the treatment to eligible customers. Ro is also a of Plenity, placing a $30 million prepaid order in late 2021.

Ro, originally named Roman, launched in 2017 and initially focused on men’s health concerns, including erectile dysfunction and hair loss. It has since expanded to cover other conditions.

Online visits with physicians through Ro are free, including those for weight loss. Patients must answer questions about their health and experiences trying to lose weight. Pregnant patients, people younger than 22, and those allergic to Plenity’s ingredients should not take it.

Information provided to Ro is not protected under the federal privacy law called the Health Insurance Portability and Accountability Act, or HIPAA, but CEO Zachariah Reitano said all data is stored in “HIPAA-compliant” ways.

Ro added Plenity to its offerings because of the clinical trial results and because it saw a business opportunity with weight loss. Help for “challenges with weight management” was one of the top items his customers requested, Reitano said.

Even though it’s not covered by his insurance plan, patient Rene Morales said the $98 a month he spends is worth it. “If I spend that [much] on coffee, I can spend it to benefit my health,” said the 51-year-old, who is president of a skateboard company in Montclair, California, and was made available for an interview by Gelesis.

He started taking Plenity in late January after his doctor brought it up during his annual physical. Morales said he has lost 15 pounds from his original weight of nearly 280 pounds and wants to stay on the treatment until he has dropped 30.

Morales said the treatment is also helping him reshape his view of food and focus on smaller portions: “I’ve come to [the] realization that you don’t have to pile your plate up to enjoy your food.”

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So it’s no surprise that some of the same drugs are being reformulated and renamed by manufacturers as a new obesity treatment. No longer limited to the crowded field of treatments for Type 2 diabetes, which of Americans, they join the far smaller number of drugs for obesity, and is ready to be mined for profit.

One that recently hit the market — winning Food and Drug Administration approval in June — is Novo Nordisk’s Wegovy, a higher-dose version of the company’s injectable diabetes drug, Ozempic.

Ozempic’s peppy ads suggest that people who use it might lose weight, but also include a disclaimer: that it “is not a weight loss drug.” Now — with a new name — it is. And clinical trials showed for many patients.

“People who go on this medication lose more weight than with any drug we’ve seen, ever,” said Dr. Fatima Cody Stanford, an obesity medicine specialist at Massachusetts General Hospital and Harvard Medical School who was not involved with any of the clinical trials.

But that leaves employers and insurers in the uncomfortable position of deciding if it’s worth it.

Wegovy’s monthly wholesale price tag — set at $1,349 — is about 58% more than Ozempic’s, although, the company points out, the drug’s injector pens contain more than twice as much of the active ingredient. Studies so far show that patients may need to take it indefinitely to maintain weight loss, translating to a tab that could top $323,000 over 20 years at the current price. Weight loss treatments are not universally covered by insurance policies.

The arrival of this new class of weight loss drugs — may soon follow — has created a thicket of issues for those who will pay for them. The decision is complicated by many unknowables concerning their long-term use and whether competition might eventually lower the price.

“The metric we try to use is value,” said James Gelfand, senior vice president for health policy at the ERISA Industry Committee, or ERIC, which represents large, self-insured employers. “If we pay for this drug, how much is this going to cost and how much value will it provide to the beneficiaries?”

have had a lackluster past in this regard, with only modest results. Many employers and insurers likely remember , a combination of fenfluramine and dexfenfluramine that was pulled from the market in the late 1990s for causing heart valve problems.

New drugs like Wegovy, more effective but also pricier than previous weight loss treatments, will add more fuel to that debate.

Past treatments were shown to prompt weight loss in the range of 5% to 10% of body weight. But many had relatively serious or unpleasant .

Wegovy, however, helped patients lose an average of 15% of their body weight over 68 weeks in the that led to its approval. A comparison group that got a placebo injection lost an average of 2.5% over the same period. On the high end, nearly a third of patients in the treatment group lost 20% or more. Both groups had counseling on diet and exercise.

Side effects, generally considered mild, included nausea, diarrhea, vomiting and constipation. A few patients developed pancreatitis, a serious inflammation of the pancreas. Like the diabetes medication, the drug carries a warning about a potential risk of a type of thyroid cancer.

Weight loss in those taking Wegovy puts it close to the 20% to 25% losses seen with bariatric surgery, said Stanford at Mass General, and well above the 3% to 4% seen with diet and other lifestyle changes alone.

Participants also saw reductions in their waistlines and improvements in their blood pressure and blood sugar levels, which may mean they won’t develop diabetes, said Dr. Sean Wharton, an internal medicine specialist and adjunct professor at York University in Toronto who was among the co-authors of the report outlining the results of the on Wegovy.

Since weight loss is known to reduce the risk of heart attack, high blood pressure and diabetes, might the new drug type be worth it?

Covering such treatment would be a sea change for Medicare, which specifically bars coverage for obesity medications or drugs for “anorexia, weight loss or weight gain,” although it does pay for bariatric surgery. Pharmaceutical companies, patient advocates and some medical professionals are backing proposed federal legislation to allow coverage. But the legislation, the Treat and Reduce Obesity Act, has not made progress despite being reintroduced every year since 2012, and sponsors are now instead to rewrite existing rules.

Private insurers will have to consider a cost-benefit analysis of adding Wegovy to their list of covered treatments, either broadly or with limits. Obesity was first recognized as a disease by the American Medical Association, easing the path for insurance coverage, in .

“Employers are going to have a bit of a challenge” deciding whether to add the benefit to insurance offerings, said Steve Pearson, founder and president of the Institute for Clinical and Economic Review, which provides cost-benefit analyses of medical treatments but has not yet looked at Wegovy.

The trade-offs are embodied in patients like Phylander Pannell, a 49-year-old Largo, Maryland, woman who said she lost 65 pounds in a clinical trial of Wegovy. That study gave the drug to all participants for the first 20 weeks, then randomly assigned patients to get either the drug or a placebo for the next 48 weeks to determine what happens when the medication is stopped. Only after the trial ended did she find out she was in the treatment group the entire time.

Her weight fell slowly at first, then ramped up, eventually bringing her 190-pound frame down to about 125. Pains in her joints eased; she felt better all around.

“I definitely feel the drug was it for me,” said Pannell, who also followed the trial’s guidance on diet and exercise.

The found that both groups lost weight in the initial 20 weeks, but those who continued to get the drug lost an additional average of 7.9% of their body weight. Those who got a placebo gained back nearly 7%.

After the trial ended, and the covid-19 pandemic hit, Pannell regained some weight and is now at 155. She is eager to get back on the medication and hopes her job-based insurance will cover it.

Many employers do cover obesity drugs. For example, about 40% of private employer plans include Novo Nordisk’s once-daily injection called Saxenda on their health plans, said Michael Bachner, Novo Nordisk’s director of media relations.

He said the $1,349-a-month wholesale acquisition price of Wegovy was determined by making it equivalent to that of Saxenda, which is less effective.

Still, that is more than the $851 monthly wholesale price of Ozempic. But, he points out, the recommended dosage of Wegovy is more than twice that of Ozempic. Four milligrams come in the Ozempic injector pens for the month, while Wegovy has 9.6.

“There’s more drug in the pen,” Bachner said. “That drives the price up.”

He added: “This is not a 20-year-old drug that we now have a new indication for and are pricing it higher. It’s a whole different clinical program,” which required new trials.

Now scientists, employers, physicians and patients will have to decide whether the new drugs are worth it.

Earlier estimates — some commissioned by Novo Nordisk — of the potential cost of adding an obesity drug benefit to Medicare showed an overall reduction in spending when better health from the resulting weight loss was factored in.

Still, those considered much less expensive drugs, including a range of generic and branded drugs costing as little as $7 a month to more than $300, a small fraction of Wegovy’s cost.

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Many Americans turn to the latest big idea to lose weight — fad diets, fitness crazes, dodgy herbs and pills, bariatric surgery, just to name a few. They’re rarely the magic solution people dream of.

Now a wave of startups offer access to a new category of drugs coupled with intensive behavioral coaching online. But already concerns are emerging.

These startups, spurred by hundreds of millions of dollars in funding from blue-chip venture capital firms, have signed up well over 100,000 patients and could reach millions more. These patients pay hundreds, if not thousands, of dollars to access new drugs, called GLP-1 agonists, along with online coaching to encourage healthy habits.

The startups initially positioned themselves in lofty terms. “This is the last weight loss program you’ll try,” said a 2020 marketing analysis by startup Calibrate Health, in messaging designed to reach one of its target demographics, the “Working Mom.” (Company spokesperson Michelle Wellington said the document does not reflect Calibrate’s current marketing strategy.)

But while doctors and patients are intrigued by the new model, some customers complain online that reality is short of the buildup: They say they got canned advice and unresponsive clinicians — and some report they couldn’t get the newest drugs.

Calibrate Health, a New York City-based startup, it had served 20,000 people. Another startup, , headquartered in San Francisco, has served 160,000 patients since July 2020. costs patients nearly $1,600 a year, not counting the price of drugs, which can hit nearly $1,500 monthly without insurance, according to drug price savings site . (Insurers reimburse for GLP-1 agonists in limited circumstances, patients said.) Found offers a six-month plan for nearly $600, a company spokesperson said. (That price includes generic drugs, but not the newer GLP-1 agonists, like Wegovy.)

The two companies are beneficiaries of over $200 million in combined venture funding, according to by , a repository of venture capital investments. The firms say they’re on the vanguard of weight care, both citing the influence of biology and other scientific factors as key ingredients to their approaches.

There’s potentially a big market for these startups. Just , according to the Centers for Disease Control and Prevention, driving up their risk for cardiovascular conditions and Type 2 diabetes. Effective medical treatments are elusive and hard to access.

Centers that provide this specialty care “are overwhelmed,” said Dr. , an obesity medicine specialist at Massachusetts General in Boston, a teaching hospital affiliated with Harvard. Her own clinic has a waitlist of 3,000.

Stanford, who said she has advised several of these telemedicine startups, is bullish on their potential.

, director of obesity medicine at the Cleveland Clinic, said the startups can offer care with less judgment and stigma than in-person peers. They’re also more convenient.

Butsch, who learned about the model through consultancies, patients, and colleagues, wonders whether the startups are operating “to strategically find which patients respond to which drug.” He said they should coordinate well with behavioral specialists, as antidepressants or other medications may be driving weight gain. “Obesity is a complex disease and requires treatments that match its complexity,” he said. “I think programs that do not have a multidisciplinary team are less comprehensive and, in the long term, less effective.”

The startups market a two-pronged product: first, the new class of GLP-1 agonists. While these medications are effective at provoking weight loss, Wegovy, one of two in this class specifically approved for this purpose, is in due to manufacturing difficulties, according to its maker, Novo Nordisk. can be prescribed off-label. But doctors generally aren’t familiar with the medications, Stanford said. In theory, the startups can bridge some of those gaps: They offer more specialized, knowledgeable clinicians.

Then there’s the other prong: behavioral changes. The companies use televisits and online messaging with nutritionists or coaches to help patients incorporate new diet and exercise habits. The weight loss figures achieved by participants in clinical trials for the new drugs — up to 15% of body mass — were tied to such changes, according to .

Social media sites are bursting with these startups’ ads, everywhere from podcasts to Instagram. A search of Meta’s ad library finds 40,000 ads on Facebook and Instagram between the two firms.

The ads complement people’s own postings on social media: Numerous Facebook groups are devoted to the new type of drugs — some even focused on helping patients manage side effects, like changes in their bowel movements. The buzz is quantifiable: On TikTok, mentions of the new GLP-1 agonists tripled from last June to this June, according to an analysis by investment bankers at Morgan Stanley.

There’s now a feverish, expectant appetite for these medications among the startups’ clientele. Patients often complained that their friends had obtained a drug they weren’t offered, recalled Alexandra Coults, a former pharmacist consultant for Found. Coults said patients may have perceived some sort of bait-and-switch when in reality clinical reasons — like drug contraindications — guide prescribing decisions.

Patient expectations influence care, Coults said. Customers came in with ideas shaped by the culture of fad diets and New Year’s resolutions, she said. “Quite a few people would sign up for one month and not continue.”

In interviews with KHN and in online complaints, patients also questioned the quality of care they received. Some said intake — which began by filling out a form and proceeded to an online visit with a doctor — was perfunctory. Once medication began, they said, requests for counseling about side effects were slow to be answered.

Jess Garrant, a Found patient, recalled that after she was prescribed zonisamide, a generic anticonvulsant that has shown some ability to help with weight loss, she felt “absolutely weird.”

“I was up all night and my thoughts were racing,” . She developed sores in her mouth.

She sought advice and help from Found physicians, but their replies, she told KHN, “weren’t quick.” Nonemergency communications are routed through the company’s portal.

It took a week to complete a switch of medications and have a new prescription arrive at her home, she said. Meanwhile, she said, she went to an urgent care clinic for the mouth sores.

Found frequently prescribes generic medications — often off-label — rather than just the new GLP-1 agonists, company executives said in an interview. Found said older generics like zonisamide are more accessible than the GLP-1 agonists advertised on social media and their own website. Both Butsch and Stanford said they’ve prescribed zonisamide successfully. Butsch said ramping up dosage rapidly can increase the risk of side effects.

But Dr. Kim Boyd, chief medical officer of competitor Calibrate, said the older drugs “just haven’t worked.”

Patients of both companies have critiqued online and in interviews the startups’ behavioral care — which experts across the board maintain is integral to successful weight loss treatment. But some patients felt they simply had canned advice.

Other patients said they had ups and downs with their coaches. Dana Crom, an attorney, said she had gone through many coaches with Calibrate. Some were good, effective cheerleaders; others, not so good. But when kinks in the program arose, she said, the coach wasn’t able to help her navigate them. While the coach can report trouble with medications or the app, it appears those reports are no more effective than messages sent through the portal, Crom said.

And what about when her yearlong subscription ends? Crom said she’d consider continuing with Calibrate.

Relationships with coaches, given the need to change behavior, are a critical element of the business models. Patients’ results depend “on how adherent they are to lifestyle changes,” said Found’s chief medical officer, .

While the startups offer care to a larger geographic footprint, it’s not clear whether the demographics of their patient populations are different from those of the traditional bricks-and-mortar model. Calibrate’s patients are overwhelmingly white; over 8 in 10 have at least an undergraduate degree; over 8 in 10 are women, according to the company.

And its earlier marketing strategies reflected that. The September 2020 “segmentation” document laid out three types of customers the company could hope to attract: perimenopausal or menopausal women, with income ranging from $75,000 to $150,000 a year; working mothers, with a similar income; and “men.”

Isabelle Kenyon, Calibrate’s CEO, said the company now hopes to expand its reach to partner with large employers, and that will help diversify its patients.

Patients will need to be convinced that the model — more affordable, more accessible — works for them. For her part, Garrant, who no longer is using Found, reflected on her experience, writing in her blog post that she was hoping for more follow-up and a more personal approach. “I don’t think it’s a helpful way to lose weight,” she said.

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For years, people with Type 1 diabetes have worn continuous glucose monitors, or CGMs, to track blood sugar spikes and make sure they’re getting enough insulin. CGMs are small patches with tiny needles for sensors that prick the skin and are generally worn on the stomach or back of the arm.

Now, a wave of tech companies are selling CGMs to the public. That made me curious: Would this work for me? What would I learn?

The devices, linked to apps with personalized analytics and meal planning advice, are being touted as a behavior-changing path to better health and athletic performance, consistent energy, and overcoming the dreaded weight-loss-weight-gain cycle once and for all.

For people without diabetes, tracking the glycemic response to meals can pinpoint which foods significantly spike blood sugar, leading to a subsequent blood sugar crash and then lethargy. That excess insulin and glucose in the blood stream can also signal to the body to put the surplus sugar in storage, causing weight gain.

The new-age, health-monitoring ecosystem sprawls well beyond CGMs, leaving traditional step counters in the dust. A tracker in the form of made by Ultrahuman monitors movement and sleep — and can be paired with a glucose-monitoring patch. ’s wearable technology, which tracks respiratory rate, blood oxygen, and other health metrics, can . Another device, the Lumen, to determine whether the user is burning carbs or fat.

The market for this technology is huge, from Olympic athletes to office workers looking to avoid the post-lunch lull. The nation has long been in the throes of what is often referred to as an obesity epidemic. From 2017 through 2021, 26% of Americans, on average, said they were “seriously trying to lose weight,” and more than half said they would like to, according to . And about 96 million U.S. adults have prediabetes, increasing their risk of developing chronic diseases like Type 2 diabetes and heart disease, . Prediabetes affects people who are both lean and overweight, though obesity does .

Investors are taking note. Nearly $3.5 billion poured into U.S. weight loss digital health startups from 2020 through the first half of 2022, according to an analysis by venture fund Rock Health for KHN. CGM startups , , , and have raised more than $140 million in funding collectively, according to company funding database Crunchbase.

There’s plenty of hype about all the data they deliver.

and in podcasts often feature active 20-somethings. They promise unique insights into how individual bodies react to food, exercise, and sleep in real time by homing in on metabolic health and how well users keep their glucose levels in check. “,” says CGM-based company Signos. A promo for Lumen shares: “You hold in your lungs the secret to sustainable weight loss.”

But even as people in the field have seen “significant” results from incorporating these tools into weight loss programs, they acknowledge that no single approach seems able to do it all. For instance, Eric Kusher, a doctor of chiropractic who runs an intensive weight loss program at , said he still relies on the human element, too, falling back on his staff’s dietary advice, not the meal guidance provided by apps.

The reality layer is also important, said Dr. , a senior scholar at Stanford University’s Clinical Excellence Research Center. “If you’re a harried mother trying to care for three kids and hold down a job, you’re not going to have time to monitor and create the perfect green shake,” he said. “You’re going to buy the dollar meal because that’s easier and cheaper for your kids — and then you’re going to eat whatever they don’t eat.”

For weight loss and inflammation flare-ups, Sarah Schacht, a 42-year-old government innovation consultant from Seattle, has tried all kinds of health tech, including Levels and Lumen. The generalized “eat less, move more” — — wasn’t working for her. The Levels app lets the user log meals, exercise, and other notable events; combines the information with CGM data; and then offers insights and advice on how users can foster gentler glucose curves. Since starting Levels a year and a half ago, she has lost 5 pounds, her weight has stabilized, and the inflammatory responses have gone down. But her body has not dramatically changed, she said.

“I get the feeling that the few success stories I’ve seen, people who have radically changed their bodies, spend a lot of time on their eating strategy,” Schacht said. “Not everyone has that mental capacity, time, or budget.”

These devices aren’t covered by insurance, so, with related subscriptions for the data, costs can be hundreds of dollars annually. There is also scant research on CGMs’ effectiveness in improving the health of people without diabetes, let alone prompting weight loss. Without firm results, many health care providers . Some experts also worry that the constant stream of data could prompt .

, co-director of the Center for Weight Management and Wellness at Brigham and Women’s Hospital in Boston, said she does not see the use of an expensive CGM for someone who doesn’t have diabetes, especially with new weight loss drugs within reach. Those drugs, of course, will also carry a hefty price tag.

“It’s hard work losing 10 pounds,” Apovian said. “A CGM is going to wipe out your money so you can’t join a gym.”

Most of the people who have insulin resistance and metabolic disease tend to be lower income and minorities who can’t afford CGMs, said , co-owner of BioCoach. has FDA clearance for its glucose and ketone meter, which checks glucose levels and tests for ketones in the blood — . Its more traditional finger-prick technology keeps the subscription price down to $30 a month while still letting people without diabetes learn about their metabolic health, though not with continuous data. The company has amassed a , where Delgado and others raise awareness about sugary foods and diabetes.

The CGM startups generally offer one of two CGMs: Abbott’s FreeStyle Libre, which is cheaper and requires a manual scan of the sensor by a smartphone, or the Bluetooth-connected Dexcom G6, which updates to a smartphone automatically. The monitors are provided to people without diabetes through “off-label” prescriptions because the FDA has not yet approved the tools for the general population.

CGMs are , so companies are betting that the FDA will approve them to be available on drugstore shelves in the U.S. That should drive down the prices of the sensors, which can cost hundreds of dollars.

But already says it can use artificial intelligence to predict a person’s glucose levels after a user wears a CGM for two weeks. The algorithm, backed by and a library of food nutrition data, can then predict the person’s glucose response to thousands of foods before the user decides what to eat, not after. This brings the cost down, essentially creating a virtual CGM, said , CEO of January. The company is rolling out a new version of its app this fall.

Across the board, the startups are largely working through the kinks, some still conducting the research to back up their marketed claims and taking different approaches to using the technology. A common theme for the startups, though, is going direct-to-consumer first — aiming for people who can afford the concept — before eventually seeking coverage from insurers, said , founder and general partner of Rock Health Capital.

The companies are also trying to add novel twists to how their apps use the data to reach health and weight-loss goals, each with libraries of informational blogs, lessons, and activities. They range in cost from hundreds of dollars annually to , with charges covering the price of the hardware, the subscription for wraparound services, and in some cases nutritionist support. The companies are banking on the idea that customers will sign on for the long term.

Taking a more wraparound approach, NutriSense has leaned heavily into building out an 80-person nutrition team that works closely with customers, according to Kara Collier, the company’s vice president of health.

Signos, which focuses on weight loss, uses artificial intelligence to set a “weight loss range” for customers depending on their general glucose ranges and level of fitness.

Out of curiosity, this reporter stuck a CGM on the back of her arm for 10 days and signed up for the Levels app. At first, the metrics were jarring. As a person without diabetes, I had never reckoned with my glucose levels before.

Then I started recognizing patterns that made sense: Drinking beer always spiked my glucose, but a bagel after a long morning walk kept my blood sugar relatively stable. Avocado toast or eggs for breakfast were better alternatives, though. And a salad with chickpeas, tomatoes, and turkey for lunch earned top marks.

Digesting data alongside every meal certainly made me think harder about what I ate and when I exercised. But it also felt like a lot of extra homework.

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Excitement is building about a new generation of drugs that tout the ability to help adults with excess weight shed more pounds than older drugs on the market.

Some patients, obesity medicine specialists say, are experiencing decreases in blood pressure, better-managed diabetes, less joint pain, and better sleep from these newfound treatments.

The newer drugs, which are repurposed diabetes drugs, “are showing weight loss unlike any other medications we’ve had in the past,” said , a psychologist and registered dietitian in the Bariatric & Metabolic Institute at the Cleveland Clinic.

Yet for him and other experts, the thrill is tempered.

That’s because no single drug is a magic solution by itself, and it’s possible many patients will need to take the to maintain results. On top of that, the newest treatments are often very costly and often not covered by insurance.

The five-figure annual costs of the new medications are also raising concern about access for patients and what widespread use could mean for the nation’s overall health care tab.

Evaluating the trade-offs — weighing the value of better health and possibly fewer complications of obesity down the road against the upfront drug costs — will increasingly come into play as insurers, employers, government programs, and others who pay health care bills consider which treatments to cover.

“If you pay too much for a drug, everyone’s health insurance goes up. Then people drop off health insurance because they can’t afford it,” so providing the drug might cause more harm to the system than not, , chief medical officer for the Institute for Clinical and Economic Review, or ICER, a nonprofit group that reviews medical evidence to evaluate treatments for effectiveness and cost.

Many commercial insurers currently limit coverage to only some of the drugs currently available, or require patients to meet certain thresholds for coverage — often pegging it to a controversial measure called “body mass index,” a ratio of height to weight. Medicare specifically bars coverage for obesity medications or drugs for “anorexia, weight loss or weight gain,” although it pays for bariatric surgery. Coverage in other government programs varies. Legislation that would allow medication coverage in Medicare — the — has not made progress despite being reintroduced every congressional session since 2012.

As insurers view the cost of treatments with concern, manufacturers see a potential financial bonanza. Morgan Stanley analysts recently said “obesity is the new hypertension” and predicted industry revenue from U.S. obesity drug sales could rise from its current $1.6 billion to $31.5 billion by 2030.

It’s easy to see how they could predict that startling number based simply on potential demand. In the U.S., 42% of adults are considered obese, up from 33% a decade earlier. Health problems sometimes linked to weight, such as and , are also on the rise.

Even losing 5% of body weight can provide health benefits, say experts. Some of the new drugs, which can help curb hunger, aid some patients in surpassing that marker.

Wegovy, which is a higher dose of the self-injectable diabetes drug Ozempic, helped patients lose an average of 15% of their body weight over 68 weeks during the clinical trial that led to its FDA approval last year. After stopping the drug, many patients followed in an extension of the trial gained back weight, which is not uncommon with almost any diet medication. Wegovy has spent much of the year in due to manufacturing issues. It can cost around $1,300 a month.

Another injectable drug, still in final clinical trials but by the FDA, could spur even greater weight loss, in the 20% range, according to Eli Lilly, its manufacturer. Both drugs mimic a hormone called glucagon-like peptide 1, which can signal the brain in ways that make .

The average weight loss from both, however, puts the drugs within striking distance of results seen following surgical procedures, offering another option for patients and physicians.

But will the range of old and new prescription medical products — with even more in the development pipeline — be the answer to America’s weight problem?

A big maybe, say experts. For one thing, the medications and devices don’t work for everyone and vary in effectiveness.

Plenity is a prime example. With a price tag of $98 a month, it’s considered by the FDA to be a device and requires a prescription. During clinical trials, about 40% of people who tried it failed to lose weight. But among the other 60%, the average weight loss was 10.2% of body weight over 24 weeks when coupled with diet and exercise.

That average puts it in line with other, older, prescription weight loss medications, which often show when taken over a year.

While it is true that weight loss drugs — both old- and new-generation — don’t work for everyone, there’s enough variation among individuals that “even the older drugs work really well for some people,” said Rind at ICER.

But it’s too soon — especially for the newer drugs — to know how long the results can last and what patients will weigh five or 10 years out, he said.

Still, advocates argue that insurers should cover treatments for weight issues as they cover those for cancer or chronic conditions like high blood pressure. Paying for such treatment could be good both for the patient and insurers’ bottom lines, they argue. Over time, insurers may pay less for people who lose weight and then avoid other health complications, but such financial gains to the health system could take years or even decades to accrue.

Financial benefits for drugmakers are mixed so far. Novo Nordisk, the maker of Wegovy and Ozempic, saw obesity care sales grow 110% in the first half of the year, driven by Wegovy, but its stock price remained flat and even dipped in September. But Lilly, which won approval for , that may soon also get the green light for weight loss, saw its September stock prices 34% higher than last September’s.

Some employers and insurers who pay health care bills are also asking whether the drugs are priced fairly.

ICER recently , comparing four weight loss medications. Two, Wegovy and Saxenda, are new-generation treatments, both made by Novo based on an existing injection diabetes drug. The other two — phentermine/topiramate, sold by Vivus as Qsymia, and bupropion/naltrexone, sold as Contrave by Currax Pharmaceuticals — are older therapies based on pill combinations.

Results were mixed, according to a report released in August, which will be finalized soon after public comments are evaluated and incorporated.

Wegovy showed greater weight loss compared with other treatments. But Qsymia also helped patients lose a substantial amount of weight, Rind said. That older drug combination has a net cost, after manufacturer discounts, of about $1,465 annually in the second year of use, compared with Wegovy, which had a net cost of $13,618 in that second year, the report said. Many patients may be prescribed weight loss drugs for years.

With such numbers, Wegovy did not meet the group’s cost-effectiveness threshold.

“It’s a great drug, but it’s about twice as expensive as it should be” when its health benefits are weighed against its cost and potential to drive up overall medical spending and health premiums, said Rind.

Don’t expect costs to go down anytime soon, though, even as other new drugs are poised to hit the market.

Lilly, for instance, has yet to reveal what Mounjaro will cost if it clears clinical trials for use as a weight loss medication. But a hint comes from its $974-a-month price as a diabetes treatment — an amount similar to that of rival diabetes drug Ozempic, Wegovy’s precursor.

Novo charges more for Wegovy than Ozempic, although the weight loss version does include more of the active ingredient. It’s possible Lilly will take a page out of that playbook and also charge more for its weight loss version of Mounjaro.

, a professor in the department of nutrition sciences at the University of Alabama-Birmingham, predicts insurance coverage will improve over time.

“It’s undeniable now that you can achieve substantial weight loss if you stay on medications — and reduce the complications of obesity,” Garvey said. “It will be hard for health insurers and payers to deny.”

One thing the new focus on medication treatment may promote, most of the experts said, is to temper the bias and stigma that has long dogged patients who are overweight or have obesity.

“The group with the highest level of weight bias is physicians,” said , an obesity medicine specialist and the equity director of the endocrine division at Massachusetts General Hospital. “Imagine how you feel if you have a physician who tells you your value is based on your weight.”

Rind sees the new, more effective therapies as another way to help dispel the notion that patients “aren’t trying hard enough.”

“It’s become more and more obvious over the years that obesity is a medical issue, not a lifestyle choice,” Rind said. “We’ve been waiting for drugs like this for a very long time.”

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That work, done in the 1830s by , appealed to life insurance companies, which created “ideal” weight tables after the turn of the century. By the 1970s and 1980s, the measurement, now dubbed body mass index, was adopted to screen for and track obesity.

Now it’s everywhere, using an equation — — to categorize patients as overweight, underweight, or at a “healthy weight.” It’s appealingly simple, with a scale that designates adults who score between 18.5 and 24.9 as within a healthy range.

But critics — and they are widespread these days — say it was never meant as a health diagnostic tool. “BMI does not come from science or medicine,” said , an obesity medicine specialist and the equity director of the endocrine division at Massachusetts General Hospital.

She and other experts said BMI can be useful in tracking population-wide weight trends, but it falls short by failing to account for differences among ethnic groups, and it can target some people, including athletes, as overweight or obese because it does not distinguish between muscle mass and fat.

Still, BMI has become a standard tool to determine who is most at risk of the health consequences of excess weight — and who qualifies for often-expensive treatments. Despite the heavy debate surrounding BMI, is that people who are overweight or obese are at greater risk for a host of health problems, including diabetes, liver problems, osteoarthritis, high blood pressure, sleep apnea, and cardiovascular problems.

The BMI measure is commonly included in the prescribing directions for weight loss drugs. Some of the newest and most effective drugs, such as Wegovy, limit use to patients who have a BMI of 30 or higher — the obesity threshold — or a lower level of 27, if the patient has at least one weight-related medical condition, such as diabetes. Doctors can prescribe the medications to patients who don’t meet those label requirements, but insurers might not cover any of the cost.

While most insurers, including Medicare, of bariatric surgery for weight loss, they might require a patient to have a BMI of at least 35, along with other health conditions, such as high blood pressure or diabetes, to qualify.

With medications, it can be even trickier. does not cover most prescription weight loss drugs, although it will cover behavioral health treatments and obesity screening. Coverage for weight loss medications varies among private health plans.

“It’s very frustrating because everything we do in obesity medicine is based on these cutoffs,” said Stanford.

Critics say that BMI can err on both ends of the scale, mistakenly labeling some larger people as unhealthy and people who weigh less as healthy, even if they need medical treatment.

For eating disorders, insurers often use BMI to make coverage decisions and can limit treatment to only those who rank as underweight, missing others who need help, said , communications director for , a nonprofit that helps patients get treatment, whether they are uninsured or have been denied care through their health plan.

“Because there’s such a focus on BMI numbers, we are missing people who could have gotten help earlier, even if they are at a medium BMI,” Nangia said. “If they are not underweight, they are not taken seriously, and their behaviors are overlooked.”

Stanford said she, too, often battles insurance companies over who qualifies for overweight treatment based on BMI definitions, especially some of the newer, pricier weight loss medications, which can cost more than $1,500 a month.

“I’ve had patients doing well on medication and their BMI gets below a certain level, and then the insurance company wants to take them off the medication,” Stanford said, adding she challenges those decisions. “Sometimes I win, sometimes I lose.”

While perhaps useful as a screening tool, BMI alone is not a good arbiter of health, said Stanford and many other experts.

“The health of a person with a 29 BMI might be worse than one with a 50 if that person with the 29 has high cholesterol, diabetes, sleep apnea, or a laundry list of things,” said Stanford, “while the person with a 50 just has high blood pressure. Which one is sicker? I would say the person with more metabolic disease.”

Additionally, BMI can for tall people and underestimate it for short ones, experts say. And it does not account for .

Case in point: “Black women who are between 31 and 33 BMI tend to have better health status even at that above-30 level” than other women and men, Stanford said.

Meanwhile, , including the long-running Nurses’ Health Study, found that Asian people had a greater risk of developing diabetes as they gained weight, compared with whites and certain ethnic groups. As a result, countries such as China and Japan have set lower BMI overweight and obesity thresholds for people of Asian descent.

Experts generally agree that BMI should not be the only measure to assess patients’ health and weight.

“It does have limitations,” said , a psychologist and registered dietitian at Cleveland Clinic’s Bariatric and Metabolic Institute. “It doesn’t tell us anything about the difference between muscle and fat weight,” he said, noting that many athletes might score in the overweight category, or even land in the obesity range due to muscle bulk.

Instead of relying on BMI, physicians and patients should consider other factors in the weight equation. One is being aware of where weight is distributed. Studies have shown that health risks increase if a person carries excess weight in the midsection. “If someone has thick legs and most of their weight is in the lower body, it’s not nearly as harmful as if they have it around their midsection, especially their organs,” said Creel.

Stanford agrees, saying midsection weight “is a much better proxy for health than BMI itself,” with the potential for developing conditions like fatty liver disease or diabetes “directly correlated with waist size.”

Patients and their doctors can use a simple tool to assess this risk: . Measuring just above the hipbone, women should stay at 35 inches or less; men, 40 inches or less, researchers advise.

New ways to define and diagnose obesity are in the works, including a panel of international experts convened by the prestigious Lancet Commission, said Stanford, a member of the group. Any new criteria ultimately approved might not only help inform physicians and patients, but also affect insurance coverage and public health interventions.

Stanford has also studied a way to recalibrate BMI to reflect gender and ethnic differences. It incorporates various groups’ risk factors for conditions such as diabetes, high blood pressure, and high cholesterol.

Based on her research, she said, the BMI cutoff would trend lower for men as well as Hispanic and white women. It would shift to slightly higher cutoffs for Black women. (Hispanic people can be of any race or combination of races.)

“We do not plan to eliminate the BMI, but we plan to devise other strategies to evaluate the health associated with weight status,” said Stanford.

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Those are pushing a product named Plenity as a potential liberation from dieters’ woes. It’s a $98-a-month weight loss treatment that looks like a drug: Patients take three capsules twice a day. But it isn’t a drug. And its success in racking up lost pounds, on average, is modest.

Plenity is FDA-approved as a device, one that contains sugar-sized grains of a plant-based, absorbent hydrogel. Each grain swells to 100 times its size, cumulatively filling about a quarter of a person’s stomach. The three capsules containing them must be taken with two cups of water at least 20 minutes before eating. The gel is not absorbed and eventually exits the body in stool.

The treatment is also generally not covered by insurance.

“We thought we would price it low enough that most consumers can pay out-of-pocket,” said Dr. Harry Leider, chief medical officer and executive vice president of Gelesis, the maker of Plenity.

Although far less costly than some other prescription weight loss treatments, it still “isn’t affordable for someone in the low-income bracket,” said Jena Shaw Tronieri, an assistant professor and director of clinical services at the University of Pennsylvania’s Center for Weight and Eating Disorders.

Plenity is designed to help patients who want to eat less, and taking it to consuming a big salad before lunch and dinner, without the actual raw vegetables.

It joins a growing selection of prescription weight loss and obesity treatments, from old-school oral medications that are often low-cost generics to far pricier brand-name injectable diabetes drugs newly repurposed as weight loss treatments. Results varied widely among trial participants; 59% of those who got Plenity lost at least 5% of their body weight, although the rest did not meet that threshold.

Plenity, whose active ingredient is a form of cellulose, embraces a strategy that has been used for decades by some people: to feel full before eating a main meal, thus reducing the calories they take in. Studies have shown that “if you fill up on broth-based soup or vegetables before a meal, you will feel fuller and eat less,” said Tronieri. She noted that filling up with water doesn’t produce the same satiating effect.

Still, some patients say that they “hate vegetables” and that “capsules are a lot easier,” said Dr. Christina Nguyen, medical director of obesity medicine at Northeast Georgia Health System. She is not affiliated with Gelesis but has been prescribing Plenity since its soft launch in late 2020.

So far, Gelesis credits the marketing campaign with helping it pick up in the first three months of the year, adding $7.5 million in revenue, although the company still lost money in the first quarter.

So where does this latest treatment fit as a potential weight loss tool for the more than 70% of American adults who are overweight or obese?

“I’m glad to see it on the market, but I tend to want more weight loss in patients than what I’m looking at with this device,” said W. Timothy Garvey, professor at the University of Alabama at Birmingham and director of the university’s Diabetes Research Center.

Gelesis reported that participants in its clinical trial who used Plenity lost on average 6.4% of body weight — above the 5% that many physicians say is a good target threshold. For a 200-pound person, that would equal almost 13 pounds. Still, that’s only a bit better than the 4.4% weight loss, on average, that people given a placebo in the experienced. All 436 participants were put on diets that averaged 300 calories a day less than they needed to maintain their weight.

Nguyen said she tells her patients they must change their eating and exercise habits or Plenity won’t work. “You have to be realistic and set expectations,” she said. “What I’ve seen with Plenity is weight loss of about 5%.”

She noted it has relatively few side effects — mainly gastrointestinal, such as bloating, nausea, constipation, or flatulence — and the FDA has approved it for use in people with lower body mass index numbers than required for many other prescription products.

Plenity’s average weight loss is comparable to or below that of some other oral medications and is far less than that of the much more expensive new additions to the market such as Novo Nordisk’s Wegovy, a once-a-week injection that costs $1,300 a month. Wegovy helped patients lose nearly 15% of their body weight over 17 months, on average, according to clinical trials. In April, an injectable drug it is testing helped patients achieve an average weight loss of 22.5%. More details were released .

“We don’t see Wegovy as a competitor,” said Leider, of Gelesis.

Nor does Leider view the weight loss products available without a prescription as competitors.

Leider said Gelesis sought FDA prescription approval for the treatment, rather than over-the-counter status, because “there’s a whole wall of nutritional supplements and products” and “we felt it was absolutely important to do the study and prove it scientifically works.” Down the road, “once we’ve built the brand,” Gelesis could seek over-the-counter status, he added.

As with other treatments, weight loss with Plenity can vary widely, he noted. Study data shows 27% of those given the treatment were considered “super responders,” losing an average of 14% of their weight. Patients with diabetes or prediabetes may respond better than those with normal blood sugar levels.

Still, it didn’t work for 40% of participants in the trial.

“If you take it for two months and you’re not losing weight, it may not be the therapy for you,” Leider said.

Patients can request Plenity from their physicians. In a move aimed at setting it apart from other treatments, Gelesis offers potential patients another choice: skipping an in-office visit entirely by requesting the treatment online. It has partnered with Ro, a direct-to-patient platform, which provides its network of affiliated physicians for online health assessments and delivers the treatment to eligible customers. Ro is also a of Plenity, placing a $30 million prepaid order in late 2021.

Ro, originally named Roman, launched in 2017 and initially focused on men’s health concerns, including erectile dysfunction and hair loss. It has since expanded to cover other conditions.

Online visits with physicians through Ro are free, including those for weight loss. Patients must answer questions about their health and experiences trying to lose weight. Pregnant patients, people younger than 22, and those allergic to Plenity’s ingredients should not take it.

Information provided to Ro is not protected under the federal privacy law called the Health Insurance Portability and Accountability Act, or HIPAA, but CEO Zachariah Reitano said all data is stored in “HIPAA-compliant” ways.

Ro added Plenity to its offerings because of the clinical trial results and because it saw a business opportunity with weight loss. Help for “challenges with weight management” was one of the top items his customers requested, Reitano said.

Even though it’s not covered by his insurance plan, patient Rene Morales said the $98 a month he spends is worth it. “If I spend that [much] on coffee, I can spend it to benefit my health,” said the 51-year-old, who is president of a skateboard company in Montclair, California, and was made available for an interview by Gelesis.

He started taking Plenity in late January after his doctor brought it up during his annual physical. Morales said he has lost 15 pounds from his original weight of nearly 280 pounds and wants to stay on the treatment until he has dropped 30.

Morales said the treatment is also helping him reshape his view of food and focus on smaller portions: “I’ve come to [the] realization that you don’t have to pile your plate up to enjoy your food.”

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So it’s no surprise that some of the same drugs are being reformulated and renamed by manufacturers as a new obesity treatment. No longer limited to the crowded field of treatments for Type 2 diabetes, which of Americans, they join the far smaller number of drugs for obesity, and is ready to be mined for profit.

One that recently hit the market — winning Food and Drug Administration approval in June — is Novo Nordisk’s Wegovy, a higher-dose version of the company’s injectable diabetes drug, Ozempic.

Ozempic’s peppy ads suggest that people who use it might lose weight, but also include a disclaimer: that it “is not a weight loss drug.” Now — with a new name — it is. And clinical trials showed for many patients.

“People who go on this medication lose more weight than with any drug we’ve seen, ever,” said Dr. Fatima Cody Stanford, an obesity medicine specialist at Massachusetts General Hospital and Harvard Medical School who was not involved with any of the clinical trials.

But that leaves employers and insurers in the uncomfortable position of deciding if it’s worth it.

Wegovy’s monthly wholesale price tag — set at $1,349 — is about 58% more than Ozempic’s, although, the company points out, the drug’s injector pens contain more than twice as much of the active ingredient. Studies so far show that patients may need to take it indefinitely to maintain weight loss, translating to a tab that could top $323,000 over 20 years at the current price. Weight loss treatments are not universally covered by insurance policies.

The arrival of this new class of weight loss drugs — may soon follow — has created a thicket of issues for those who will pay for them. The decision is complicated by many unknowables concerning their long-term use and whether competition might eventually lower the price.

“The metric we try to use is value,” said James Gelfand, senior vice president for health policy at the ERISA Industry Committee, or ERIC, which represents large, self-insured employers. “If we pay for this drug, how much is this going to cost and how much value will it provide to the beneficiaries?”

have had a lackluster past in this regard, with only modest results. Many employers and insurers likely remember , a combination of fenfluramine and dexfenfluramine that was pulled from the market in the late 1990s for causing heart valve problems.

New drugs like Wegovy, more effective but also pricier than previous weight loss treatments, will add more fuel to that debate.

Past treatments were shown to prompt weight loss in the range of 5% to 10% of body weight. But many had relatively serious or unpleasant .

Wegovy, however, helped patients lose an average of 15% of their body weight over 68 weeks in the that led to its approval. A comparison group that got a placebo injection lost an average of 2.5% over the same period. On the high end, nearly a third of patients in the treatment group lost 20% or more. Both groups had counseling on diet and exercise.

Side effects, generally considered mild, included nausea, diarrhea, vomiting and constipation. A few patients developed pancreatitis, a serious inflammation of the pancreas. Like the diabetes medication, the drug carries a warning about a potential risk of a type of thyroid cancer.

Weight loss in those taking Wegovy puts it close to the 20% to 25% losses seen with bariatric surgery, said Stanford at Mass General, and well above the 3% to 4% seen with diet and other lifestyle changes alone.

Participants also saw reductions in their waistlines and improvements in their blood pressure and blood sugar levels, which may mean they won’t develop diabetes, said Dr. Sean Wharton, an internal medicine specialist and adjunct professor at York University in Toronto who was among the co-authors of the report outlining the results of the on Wegovy.

Since weight loss is known to reduce the risk of heart attack, high blood pressure and diabetes, might the new drug type be worth it?

Covering such treatment would be a sea change for Medicare, which specifically bars coverage for obesity medications or drugs for “anorexia, weight loss or weight gain,” although it does pay for bariatric surgery. Pharmaceutical companies, patient advocates and some medical professionals are backing proposed federal legislation to allow coverage. But the legislation, the Treat and Reduce Obesity Act, has not made progress despite being reintroduced every year since 2012, and sponsors are now instead to rewrite existing rules.

Private insurers will have to consider a cost-benefit analysis of adding Wegovy to their list of covered treatments, either broadly or with limits. Obesity was first recognized as a disease by the American Medical Association, easing the path for insurance coverage, in .

“Employers are going to have a bit of a challenge” deciding whether to add the benefit to insurance offerings, said Steve Pearson, founder and president of the Institute for Clinical and Economic Review, which provides cost-benefit analyses of medical treatments but has not yet looked at Wegovy.

The trade-offs are embodied in patients like Phylander Pannell, a 49-year-old Largo, Maryland, woman who said she lost 65 pounds in a clinical trial of Wegovy. That study gave the drug to all participants for the first 20 weeks, then randomly assigned patients to get either the drug or a placebo for the next 48 weeks to determine what happens when the medication is stopped. Only after the trial ended did she find out she was in the treatment group the entire time.

Her weight fell slowly at first, then ramped up, eventually bringing her 190-pound frame down to about 125. Pains in her joints eased; she felt better all around.

“I definitely feel the drug was it for me,” said Pannell, who also followed the trial’s guidance on diet and exercise.

The found that both groups lost weight in the initial 20 weeks, but those who continued to get the drug lost an additional average of 7.9% of their body weight. Those who got a placebo gained back nearly 7%.

After the trial ended, and the covid-19 pandemic hit, Pannell regained some weight and is now at 155. She is eager to get back on the medication and hopes her job-based insurance will cover it.

Many employers do cover obesity drugs. For example, about 40% of private employer plans include Novo Nordisk’s once-daily injection called Saxenda on their health plans, said Michael Bachner, Novo Nordisk’s director of media relations.

He said the $1,349-a-month wholesale acquisition price of Wegovy was determined by making it equivalent to that of Saxenda, which is less effective.

Still, that is more than the $851 monthly wholesale price of Ozempic. But, he points out, the recommended dosage of Wegovy is more than twice that of Ozempic. Four milligrams come in the Ozempic injector pens for the month, while Wegovy has 9.6.

“There’s more drug in the pen,” Bachner said. “That drives the price up.”

He added: “This is not a 20-year-old drug that we now have a new indication for and are pricing it higher. It’s a whole different clinical program,” which required new trials.

Now scientists, employers, physicians and patients will have to decide whether the new drugs are worth it.

Earlier estimates — some commissioned by Novo Nordisk — of the potential cost of adding an obesity drug benefit to Medicare showed an overall reduction in spending when better health from the resulting weight loss was factored in.

Still, those considered much less expensive drugs, including a range of generic and branded drugs costing as little as $7 a month to more than $300, a small fraction of Wegovy’s cost.

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