New Plenity weight loss treatment gets heavy marketing. How well does it work?

First came the “edible billboard,” which appeared last year while on vacation in New York’s East Village laden with goodies. 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 enjoy eating.

These advertising messages are promoting a product called Plenity as a potential release from dieters’ problems. It’s a $98-a-month weight-loss treatment that looks like a drug: Patients take three capsules twice a day. But it’s not a drug. And their success in accumulating lost pounds, on average, is modest.

fullness capsules
Plenity, a weight loss treatment by Gelesis, was developed to help people feel full with smaller portions.

Business Wire via AP

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

Treatment is also usually not covered by insurance.

“We thought the price would be low enough that most consumers could pay out of pocket,” said Dr. Harry Leider, Chief Medical Officer and Executive Vice President of Gelesis, maker of Plenity.

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

Plenity is designed to help patients who want to eat less, and taking it is comparable to consuming a large 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 much more expensive brand-name injectable diabetes medications recently repurposed as weight loss treatments. Weight. Results varied widely among study participants; 59% of those who received Plenity lost at least 5% of their body weight, although the rest did not reach that threshold.

Plenity, whose active ingredient is a form of cellulose, adopts a strategy that has been used for decades by some people: feeling full before eating a main meal, thus reducing the calories ingested. in broth or vegetable-based soup before a meal, you’ll feel fuller and eat less,” Tronieri said. She noted that filling with water doesn’t produce the same satiating effect.

Still, some patients “say they hate vegetables” and that “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 been prescribing Plenity since its soft release in late 2020.

So far, Gelesis credits the marketing campaign with helping it gain 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 in 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 I see with this device,” said W. Timothy Garvey, a professor at the University of Alabama-Birmingham and director of the university’s Diabetes Research Center. .

Gelesis reported that participants in its clinical trial who used Plenity had an average weight loss of 6.4% of body weight – up from the 5% that many doctors say is a good target limit. For a 200-pound person, that would equate to almost 13 pounds. Still, that’s only slightly better than the 4.4% weight loss, on average, that people who received a placebo in the six-month trial experienced. All 436 participants were on diets with an average of 300 fewer calories per day than needed to maintain weight.

Nguyen said he tells his patients that 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 about a 5% weight loss.”

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

The average weight loss of Plenity is comparable to or less than that of some other oral medications and is much less than that of much more expensive new additions on the market such as Wegovy by Nova Nordisk, a once-a-week injection that costs $1,300 a month. Wegovy has helped patients lose nearly 15% of their body weight in 17 months on average, according to clinical trials. In April, Eli Lilly said an injection drug it is testing has helped patients achieve an average weight loss of 22.5%. More details were released on June 4.

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

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Leider also does not view over-the-counter weight loss products 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 works.” scientifically.” In the future, “once we build the brand,” Gelesis may seek over-the-counter status, he added.

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

Still, it didn’t work for 40% of study participants.

“If you take 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 doctors. In a move that aims to differentiate it from other treatments, Gelesis offers potential patients another option: skipping an office visit altogether by ordering treatment online. It has partnered with Ro, a direct-to-patient platform, which provides its network of affiliate physicians for online health assessments and offers treatment to qualified clients. Ro is also a big buyer for Plenity, placing a $30 million prepaid order at the end of 2021.

Ro, originally named Roman, was 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 consultations with doctors through Ro are free, including for weight loss. Patients must answer questions about their health and experiences in trying to lose weight. Pregnant patients, people under the age of 22 and people who are allergic to the ingredients in Plenity should not take it.

The 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 that all data is stored in a “HIPAA-compliant” manner.

Ro added Plenity to its offerings because of clinical trial results and because it saw a business opportunity with weight loss. Help with “weight management challenges” was one of the top items requested by its customers, 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 it [much] in coffee, I can spend it to benefit my health,” said the 51-year-old, who is president of a skateboarding company in Montclair, Calif., and was made available for an interview by Gelesis.

He started taking Plenity in late January after his doctor mentioned it during his annual physical. Morales said he has lost 15 pounds from his original weight of nearly 280 pounds and wants to continue treatment until he drops 30.

Morales said the treatment is also helping him to reframe his view of food and focus on smaller portions: [the] realization 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 Research, KHN is one of the three main operational programs of the KFF (Kaiser Family Foundation). KFF is a non-profit organization that provides information on health issues to the nation.

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