The new weight loss treatment is characterized by heavy marketing and modest results

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

Those advertisements are pushing a product called Plenity as a potential dieter’s release from woes. It’s a $ 98 / month slimming treatment that looks like a drug – patients take three capsules twice a day. But it is not a drug. And his success in accumulating lost pounds, on average, is modest.

Plenity is an FDA approved device, one that contains sugar 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 that contain them must be taken with two glasses of water at least 20 minutes before consumption. The gel is not absorbed and eventually exits the body in the stool.

Furthermore, the treatment is generally not covered by insurance.

“We thought we were priced low enough for most consumers to pay out of their own pockets,” said Dr. Harry Leider, medical director and executive vice president of Gelesis, the creator of Plenity.

While much less expensive than 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 Center for Weight. University of Pennsylvania and Eating Disorders.

Plenity is designed to help patients who want to eat less, and taking it is comparable to having a large salad before lunch and dinner, without the real 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 branded injectable diabetes medications recently repurposed as treatments for weight loss. Results varied widely among study participants; 59% of those who obtained Plenity lost at least 5% of their body weight, even if the rest did not reach that threshold.

Plenity, whose active ingredient is a form of cellulose, embraces a strategy that some people have used for decades: feeling full before having a main meal, thus reducing the calories they consume. Studies have shown that “if you fill up on broth-based soup or vegetables before meals, you’ll feel fuller and eat less,” said Tronieri. You have noticed that filling with water does not produce the same satiating effect.

However, some patients say they “hate vegetables” and that “capsules are a lot easier,” said Dr. Christina Nguyen, medical director of obesity medicine at Northeast Georgia Health System. She is not affiliated with Gelesis but has since prescribed Plenity for its gradual launch at the end of 2020.

So far, Gelesis credits the marketing campaign with helping it garner 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 over 70% of overweight or obese American adults?

“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, professor at the University of Alabama at Birmingham and director of the University 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% which many doctors believe is a good target threshold. For a 200-pound person, that would equate to nearly 13 pounds. However, it’s just a little better than the 4.4% weight loss, on average, that people who were given a placebo in the six-month study experienced. All 436 participants underwent diets with an average of 300 fewer calories per day than needed to maintain their weight.

Nguyen said he tells his 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 saw with Plenity is about 5% weight loss.”

He 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 in people with BMI numbers lower than those required for many other prescription products. .

Plenity’s average weight loss is comparable or less than that of other oral medications and is much lower than that of much more expensive new additions to the market like Novo Nordisk’s Wegovy, a once-a-week injection that costs $ 1,300 a month . Wegovy has helped patients lose nearly 15 percent of their body weight in 17 months, on average, according to clinical studies. In April, Eli Lilly said that an injectable drug he is testing has helped patients achieve an average weight loss of 22.5%. More details were released on June 4th.

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

Nor does Leider consider weight loss products available without a prescription as competitors.

Leider said Gelesis has sought approval of the FDA’s prescription for the treatment, rather than over-the-counter status, because “there is a whole wall of supplements and nutritional products” and “we felt it was absolutely important to do the study. and prove it works scientifically. “Along the way,” 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, she noted. The study data shows that 27% of those who received the treatment were considered “super responders”, losing 14% of their weight on average. Patients with diabetes or prediabetes may respond better than those with normal blood sugar levels.

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

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

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

Ro, originally called 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 must answer questions about their health and experiences they try to lose weight. Pregnant patients, people under the age of 22 and those allergic to the ingredients of 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 all data is stored in “HIPAA compliant” ways.

Ro added Plenity to her offerings due to clinical trial results and because she saw a business opportunity with weight loss. Help with “weight management challenges” was one of the main items requested by her clients, Reitano said.

While it’s not covered under his insurance plan, patient Rene Morales said $ 98 a month is worth spending. “If I spend it [much] on coffee, I can spend it for the benefit of my health, “said the 51-year-old 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 lifted him during his annual medical examination. Morales said he has lost 15 pounds from his original weight of nearly 280 pounds and wants to continue the treatment until he’s down by 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. “

This article was reprinted from khn.org with permission from the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorial independent news service, is a program of the Kaiser Family Foundation, a non-partisan health policy research organization not affiliated with Kaiser Permanente.