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

First came the “edible billboardwhich appeared last year during the holiday season in New York’s East Village, brimming with cake 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. don’t enjoy food.

That advertising messages pushing a product called Plenity as a possible deliverance from the misery of dieters. 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 medicine. And the success in collecting lost pounds is modest on average.

Plenity capsules
Plenity, a slimming treatment from Gelesis, is designed to help people be satisfied with smaller portions.

Business Wire through AP

Plenity is FDA-approved as a device containing sugary granules 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 they contain should be taken with two cups of water at least 20 minutes before eating. The gel is not absorbed and eventually leaves the body in the stool.

The treatment is generally not reimbursed by insurance.

“We thought we would price it so low that most consumers can afford it out of pocket,” says Dr. Harry Leider, Chief Medical Officer and Executive Vice President of Gelesis, creator of Plenity.

While it’s much less expensive than some other prescription weight-loss treatments, it’s still “not affordable for someone on a low income,” says Jena Shaw Tronieri, an assistant professor and director of clinical services at the University’s Center for Weight. or Pennsylvania. and eating disorders.

Plenity is designed to help patients who want to eat less and use it is comparable to consuming a large salad for lunch and dinner, without the actual raw vegetables.

It joins a growing selection of prescription weight loss and obesity treatments, from old-fashioned oral medications that are often inexpensive generics to much more expensive brand-name injectable diabetes medications that have recently been repurposed as weight loss treatments. The results varied widely between trial 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, espouses a strategy that has been used by some people for decades: feeling full before eating a main meal, thereby cutting back on calories. Studies have shown that “if you have broth-based soup or vegetables before a meal, you’ll feel fuller and eat less,” Tronieri said. She noted that filling with water doesn’t have the same satiating effect.

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

So far, Gelesis credits the marketing campaign with helping to pick up 40,000 new customers 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 aid for the more than 70% of American adults who are overweight or obese?

“I’m happy 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 University of Alabama-Birmingham professor and director from the University’s Diabetes Research Center.

Gelesis reported that participants in his clinical trial who took Plenity had an average weight loss of 6.4% of body weight — more than the 5% that many doctors believe is a good target threshold. For a 200-pound person, that would equal almost 13 pounds. Still, that’s only slightly better than the 4.4% weight loss average that people who received a placebo in the… six month trial experienced. All 436 participants were fed a diet with an average of 300 calories per day less than they needed to maintain their weight.

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

She noted that 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 a lower body mass index number than required for many other prescription products.

The average weight loss of Plenity is comparable to or lower than that of some other oral medications and is much less than that of the much more expensive new additions to the market such as Novo Nordisk’s Wegovyan injection once a week that costs $1,300 per month† Wegovy helped patients lose an average of nearly 15% of their body weight in 17 months, according to clinical studies. in April, Eli Lilly said: an injectable drug it’s testing helped patients achieve an average weight loss of 22.5%. More details have been released June 4

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

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Leider doesn’t see the over-the-counter weight loss products as competitors either.

Leader said Gelesis was seeking FDA approval for the treatment, rather than over-the-counter status, because “there is a whole wall of nutritional supplements and products” and “we felt it was absolutely important to do the research and prove that it works scientifically.” Moving on, “once we build the brand,” Gelesis could seek over-the-counter status, he added.

As with other treatments, weight loss with Plenity can vary widely, he noted. Research data shows that 27% of those who received the treatment were considered ‘superresponders’, losing an average of 14% of their weight. Patients with diabetes or prediabetes may respond better than patients with normal blood sugar levels.

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

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

Patients can request Plenity from their doctor. In an effort to differentiate it from other treatments, Gelesis offers potential patients another choice: to skip a visit to the practice entirely by requesting the treatment online. It partners with Ro, a direct-to-patient platform, which powers its network of affiliated physicians for online health assessments and delivers the treatment to eligible customers. Ro is also a big buyer of Plenity, which will place a $30 million prepaid order at the end of 2021.

Ro, originally called Roman, was 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 to doctors through Ro are free, including those for weight loss. Patients should answer questions about their health and weight loss experiences. Pregnant patients, people under the age of 22 and people who are allergic to the ingredients of Plenity should not use it.

Information provided to Ro is not protected by the federal privacy law, 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 offering because of the results of clinical trials and because it saw a business opportunity with weight loss. Help for “weight management challenges” was one of the key items his clients asked for, Reitano said.

Although 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] 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 an interview by Gelesis.

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

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

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism on health issues. Together with Policy Analysis and Polling, KHN is one of the three most important operational programs on KFF (Kaiser Family Foundation). KFF is an endowed non-profit organization that provides information on health issues to the nation.

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