New weight loss treatment is marked by heavy marketing and modest results

First came the “edible billboard,” which popped up last year during the holidays in New York’s East Village laden with treats. Then, in late January, came the national marketing campaign, with TV and digital media promoting the idea that trying to lose weight doesn’t mean a person can’t like to eat.

These commercials are pushing a product named Plenity as a potential release from dieters’ woes. It’s a $98-a-month weight-loss treatment that’s like medicine: Patients take three capsules twice a day. But it’s not a drug. And its success in piling on the lost pounds, on average, is modest.

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

The treatment is also usually not covered by insurance.

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

Although much less expensive than some other prescription weight loss treatments, it “still isn’t affordable for someone on a low income,” said Jena Shaw Tronieri, assistant professor and director of clinical services at the Center for Weight Loss. the University of Pennsylvania. and eating disorders.

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

It joins a growing selection of prescription weight loss and obesity treatments, ranging from old-fashioned oral medications that are often inexpensive generics to much more expensive brand-name injectable diabetes drugs newly repurposed as loss treatments. weight. Results varied widely among trial participants; 59% of those who received Plenity lost at least 5% of their body weight, although the rest did not reach this threshold.

Plenity, whose active ingredient is a form of cellulose, adopts a strategy that some people have used for decades: feeling full before eating a main meal, thereby reducing caloric intake. Studies have shown that “if you fill up on a broth-based soup or vegetables before a meal, you’ll feel fuller and eat less,” Tronieri said. She noted that filling up with water doesn’t produce the same satiating effect.

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

So far, Gelesis credits the marketing campaign with helping it attract 40,000 new customers in the first three months of the year, adding $7.5 million in revenue, though the company still lost money in the first quarter.

So where does this latest treatment fit as a potential weight loss tool for over 70% of overweight or obese American adults?

“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, a 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 an average of 6.4% of their body weight – above the 5% that many doctors consider a good target threshold. For a 200-pound person, that would equate to nearly 13 pounds. Still, that’s only slightly better than the 4.4% weight loss, on average, of people given a placebo in the six-month lived trial. The 436 participants followed diets that averaged 300 fewer calories a day than they needed to maintain their weight.

Nguyen said she tells her patients they need to 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 about a 5% weight loss.”

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

Plenity’s average weight loss is on par with or less than some other oral medications and is much lower than much more expensive new additions on the market such as Novo Nordisk’s Wegovy, a weekly injection that costs $1,300 per month . Wegovy helped patients lose almost 15% of their body weight over 17 months, on average, according to clinical trials. In April, Eli Lilly said an injectable drug it is testing helped patients lose weight by an average of 22.5%. More details were released on June 4.

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

Leider also does not consider over-the-counter weight loss products to be competitors.

Leider said Gelesis sought FDA prescription approval for the treatment, rather than over-the-counter status, because “there is a whole wall of nutritional supplements and products out there” and “we felt there It was absolutely important to do the study and prove it works scientifically.” Later, “once we build the brand,” Gelesis could apply for OTC status, he added.

As with other treatments, weight loss with Plenity can vary widely, he noted. Data from the study shows that 27% of people who received 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 trial participants.

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

Patients can request Plenity from their doctor. In a move to differentiate it from other treatments, Gelesis offers potential patients another choice: skip an office visit entirely by requesting the treatment online. It has partnered with Ro, a direct-to-patient platform, which provides its network of affiliate doctors for online health assessments and provides treatment to eligible clients. Ro is also a big buyer of Plenity, placing a prepaid order for $30 million at the end of 2021.

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

Online visits with doctors via Ro are free, including those for weight loss. Patients are asked questions about their health and their experiences trying to lose weight. Pregnant patients, people under the age of 22, and people allergic to ingredients in Plenity should not take it.

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

Ro added Plenity to his offerings because of clinical trial results and because he saw a business opportunity with weight loss. Help with “weight management challenges” was a top request from her clients, Reitano said.

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

He started taking Plenity at the end of January after his doctor mentioned it during his annual checkup. Morales said he had lost 15 pounds from his initial weight of almost 280 pounds and wanted to continue treatment until he had lost 30.

Morales said the treatment also helped her reshape her outlook on food and focus on smaller portions: “I came to [the] realizing that you don’t have to stack your plate to enjoy your food.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism on health issues. Along with policy analysis and polls, KHN is one of the three main operating programs of the KFF (Kaiser Family Foundation). KFF is an endowed non-profit organization providing information on health issues to the nation.

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