First came the “edible billboard” that appeared in New York’s East Village during the holidays last year, loaded 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’t enjoy eating.
Those advertising messages push a product called Plenity as a potential deliverance from dieters’ misery. It’s a $98-a-month weight-loss treatment that looks like a drug: Patients take three capsules twice a day. But it is not a drug. And its success in gaining lost pounds is modest on average.
Plenity is FDA-approved as a device, one that contains sugar-sized granules of a plant-based, absorbent hydrogel. Each pellet swells to 100 times its size, cumulatively filling about a quarter of a person’s stomach. The three capsules it contains should be taken at least 20 minutes before eating with two cups of water. The gel is not absorbed and eventually leaves the body in stool.
The treatment is also generally not covered by insurance.
“We thought we would price it 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, said.
While it’s much cheaper than some other prescription weight-loss treatments, it’s still “not affordable for someone in the low-income bracket,” says Jena Shaw Tronieri, an assistant professor and director of clinical services at the University of Pennsylvania Center for Weight. and eating disorders.
Plenity is designed to help patients who want to eat less, and taking it is comparable to a large salad before lunch and dinner, without the actual raw vegetables.
It joins a growing selection of prescription treatments for weight loss and obesity, from old-school oral medications that are often cheap generics to much more expensive brand-name injectable diabetes drugs that are new to weight loss treatments. Results varied widely among trial participants; 59% of those given 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, embraces a strategy that has been used by some people for decades: to feel full before eating a main meal, thereby reducing the calories they consume. Studies have shown that “if you fill up on broth-based soup or vegetables before a meal, you’ll feel fuller and eat less,” Tronieri said, noting that filling up on water doesn’t have the same satiating effect.
Still, some patients say they “hate vegetables” and that “capsules are much easier,” says 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 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 newest 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 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 Centre.
Gelesis reported that participants in its clinical trial using Plenity lost an average of 6.4% of body weight — above the 5% that many doctors say 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, on average, that people gave a placebo experienced in the six-month trial. All 436 participants were put on diets that averaged 300 calories less per 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 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 lower body mass index numbers than are required for many other prescription products.
Plenity’s average weight loss is comparable to or below that of some other oral medications and far less than that of much more expensive new additions to the market such as Novo Nordisk’s Wegovy, a once-weekly injection that costs $1,300 a month. On average, Wegovy helped patients lose nearly 15% of their body weight over 17 months, according to clinical trials. In April, Eli Lilly said an injectable drug it was testing helped patients achieve an average weight loss of 22.5%. More details were released on June 4.
“We do not see Wegovy as a competitor,” said Leider van Gelesis.
Leider also does not consider the 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’s a whole wall of nutritional supplements and products out there” and “we felt it was absolutely important to do the study and proving that it works scientifically.” Down the road, “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. Study data shows that 27% of those given the treatment are 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.
However, it did not work for 40% of the participants in the trial.
“If you take it for two months and you don’t lose weight, it might not be the therapy for you,” Leider said.
Patients can request Plenity from their doctors. In a move aimed at differentiating it from other treatments, Gelesis offers potential patients another choice: to skip an office visit altogether by requesting the treatment online. It has partnered with Ro, a direct-to-patient platform, which provides its network of affiliated doctors for online health assessments and delivers the treatment to eligible customers. Ro is also a major buyer of Plenity, which placed a $30 million prepaid order at the end of 2021.
Ro, originally named Roman, launched in 2017 and initially focused on men’s health care, including erectile dysfunction and hair loss. It has since expanded to cover other conditions.
Online visits with doctors by Ro are free, including those for weight loss. Patients must answer questions about their health and weight loss experiences. Pregnant patients, people under 22 and those who are 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 his offerings because of the clinical trial results and because he saw a business opportunity with weight loss. Help for “weight management challenges” was one of the top items his clients 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 it [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, Calif., 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 continue the treatment until he drops 30.
Morales said the treatment also helps him reshape his view of food and focus on smaller portions: “I came to [the] realize that you don’t have to pile up your plate to enjoy your food.”
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