First came “edible billboard, “Which appeared last year during the East Village holidays in New York, loaded with cake treats. Then, at the end of January, came the national marketing campaign with television and digital media, which promoted the idea that trying to lose weight does not mean that one can not enjoy eating.
These advertising messages pass a product called Plenity as a potential relief from the problems of people who follow a diet. This is a $ 98 a month weight loss treatment that looks like a cure: patients take three capsules twice a day. But this is not a drug. And his success in gaining lost pounds is, on average, modest.
Plenity is approved by the FDA as a device that contains grains the size of a sugar absorbent hydrogel. Each grain swells 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 a meal. The gel is not absorbed and eventually leaves the body in the feces.
Treatment is also usually not covered by insurance.
“We thought we would rate it low enough for most consumers to be able to pay out of pocket,” he said. Harry Leider, Chief Medical Officer and Executive Vice President of Gelesis, the manufacturer of Plenity.
Although much cheaper than some other prescription weight loss treatments, it is still “not available to low-income people,” said Jenna Shaw Tronieri, assistant and director of clinical services at the University of Pennsylvania. Eating disorders.
Plenity is designed to help patients who want to eat less and take it is comparable to eat a large salad before lunch and dinner without the actual raw vegetables.
He joins a growing selection of prescription weight loss and obesity drugs, from old oral drugs, which are often cheap generic drugs, to far more expensive branded injectable drugs for diabetes, recently developed as a weight loss treatment. Results vary considerably between study 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, encompasses a strategy that has been used for decades by some people: to feel full before eating a main meal, thus reducing the calories they consume. Studies show that “if you eat broth-based soup or vegetables before meals, you’ll feel fuller and eat less,” Tronieri said. She noted that filling with water does not lead to the same saturating effect.
However, some patients say they “hate vegetables” and that “capsules are much easier,” he said. Christina Nguyen, Medical Director of Obesity Medicine in the Health System of Northeast Georgia. It is not affiliated with Gelesis, but has been prescribing Plenity since its soft launch in late 2020.
So far, Gelesis attributes the marketing campaign to its development 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 in as a potential weight loss tool for more than 70% of older Americans 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 see with this device,” said W. Timothy Garvey, a professor at the University of Alabama at Birmingham and director of the University Center for diabetes research.
Gelesis reports that participants in its clinical trial who used Plenity lost an average of 6.4% of their body weight – more than 5%, which many doctors say is a good target. For a person weighing 200 pounds, this would be almost 13 pounds. Still, this is only slightly better than the average weight loss of 4.4% that people receive placebo in a six-month trial period experienced. All 436 participants were put on diets that averaged 300 calories a day less than they needed to maintain their weight.
Nguyen said he was telling his patients that they needed to change their eating and exercise habits or Plenity would not work. “You have to be realistic and set expectations,” she said. “What I saw with Plenity is a weight loss of about 5%.”
She noted that there were relatively few side effects – mainly gastrointestinal, such as bloating, nausea, constipation or flatulence – and the FDA approved it for use in people with a lower body mass index than is required for many other products. dispensed with a prescription.
The average weight loss of Plenity is comparable to or below that of some other oral medicines and is much lower than that of much more expensive new supplements on the market such as Novo Nordisk’s Wegovy injection once a week. it costs $ 1,300 a month. Wegovy helped patients lose nearly 15% of their body weight in an average of 17 months, according to clinical studies. In April, said Eli Lily an injectable drug he tested helped patients achieve an average weight loss of 22.5%. More details have been published June 4.
“We do not see Wegovy as a competitor,” said Leider of Gelesis.
Nor does Leider view over-the-counter weight loss products as competitors.
Leider said Gelesis sought FDA approval for treatment, not non-prescription status, because “there is a whole wall of supplements and products” and “we felt it was absolutely important to do the research and prove it works scientifically.” . “Down the road, ‘once we build the brand,’ Gelesis may seek free sale status,” he added.
As with other treatments, weight loss with Plenity can vary greatly, he noted. The survey data showed that 27% of those who received treatment were considered “super-responsive”, 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 the participants in the experiment.
“If you take it for two months and don’t lose weight, this may not be the therapy for you,” Leider said.
Patients can request Plenity from their doctors. In a move to differentiate it from other treatments, Gelesis offers potential patients another option: to skip the office visit by requesting treatment online. It partners with Ro, a direct patient care platform that provides its network of connected physicians for online health assessments and delivers treatment to eligible clients. Ro is also a big buyer of Plenity by placing a prepaid order of $ 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 to doctors through Ro are free, including those for weight loss. Patients need to answer questions about their health and experience in trying to lose weight. Pregnant patients, people under the age of 22 and allergic to Plenity ingredients 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 Zacharia Reitano said all data is stored in “HIPAA-compliant” ways.
Ro added Plenity to his proposals because of the results of clinical trials and because he saw a business opportunity with weight loss. Aid for weight management challenges was one of the most important things his clients asked for, Reitano said.
Although not covered by his insurance plan, patient Rene Morales said the $ 98 a month he spends is worth it. “If I spend that [much] for coffee, I can spend it to take advantage of my health, “said the 51-year-old, who is president of a skateboard company in Moncler, California, and was interviewed by Gelesis.
He started taking Plenity in late January after his doctor told him about it during his annual check-up. Morales said he had lost 15 pounds from his original weight of nearly 280 pounds and wanted to continue treatment until he lost 30.
Morales said the treatment also helped him change his outlook on food and focus on smaller portions: “I got to [the] realizing that you don’t have to pile up your plate to enjoy your food. ”