This new weight loss treatment is characterized by extensive marketing and modest results

came first”edible plateLast year, during the holidays in New York’s East Village came packed with cake. Then, in late January, came the national marketing campaign, in which television and digital media promoted the idea that trying to lose weight doesn’t mean a person can’t enjoy eating.

those Advertising messages They are pushing a product called Plenity as a potential release from the woes 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 is not a medicine. And her success in collecting lost pounds is, on average, modest.

Plenity is approved as a device, containing sugar-sized granules of absorbent vegetable hydrogel. Each pill swells to 100 times its size, cumulatively filling a quarter of a person’s stomach. The three capsules they contain should be taken with two glasses of water at least 20 minutes before eating. The gel is not absorbed and is eventually excreted from the body in the feces.

Treatment is not generally covered by insurance.

“We thought we would set a price low enough that most consumers could pay out of their own pockets,” said Dr. Harry Leader, chief medical officer and executive vice president of Gelesis, the manufacturer of Plenity.

Although it’s much less expensive than some other prescription weight loss treatments, it’s still “not affordable for someone on a low income,” said Gina Shaw Troneri, associate 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 eat less comparable For a great salad before lunch and dinner, without the actual raw veggies.

It joins a growing group of prescription weight loss and obesity treatments, from older and often low-cost oral medications to higher-priced, brand-new injectable diabetes medications that are newly repurposed as weight loss treatments. Results differed widely among the trial participants. 59% of those who got Plenity lost at least 5% of their body weight, although the rest did not meet that limit.

Plenity, whose active ingredient is a form of cellulose, adopts a strategy that some people have used for decades: feel full before eating a main meal, thus reducing the calories they eat. Studies have shown that, “If you fill up on your body. If you eat a broth-based or vegetable soup before a meal, you will feel full and eat less,” Troneri said. She noted that filling with water does not produce the same saturation effect.

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

So far, Gelesis credits the marketing campaign with helping it recover 40 thousand new customers In the first three months of the year, it added $7.5 million in revenue, though the company still lost money in the first quarter.

So where does this latter treatment fit as a potential weight loss tool for the more than 70% of American adults who are overweight or obese?

“I am happy to see it on the market, but I tend to lose weight in patients more than I look forward to using this device,” said W Timothy Garvey, professor at the University of Alabama at Birmingham and director. From the University’s Diabetes Research Center.

Gelesis reports that participants in its clinical trial who used Plenity lost an average of 6.4% of their body weight — above the 5% that many clinicians say is a good target threshold. For a 200-pound person, that equals approximately 13 pounds. However, this is slightly better than the 4.4% weight loss, on average, that people who took a placebo experienced. Six months on trial tested. All 436 participants were put on a diet averaging 300 calories per day less than they would need to maintain their weight.

Nguyen said she tells her patients that they must change their eating and exercise habits, or abundance will not work. “You have to be realistic and set expectations,” she said. “What I’ve seen with Plenity is a weight loss of about 5%.”

It noted that it has relatively few side effects — mainly in the digestive system, such as bloating, nausea, constipation or flatulence — and has been approved by the U.S. Food and Drug Administration for use in people with lower BMI numbers than is required for many other medicinal products. .

Plenty’s average weight loss is comparable to or below that of some other oral medications, and much less than that of more expensive new additions to the market such as Novo Nordisk WeGov, a once-weekly injection. Which costs $1300 a month. Wegovy helped patients lose nearly 15% of their body weight over an average of 17 months, according to clinical trials. in April, Eli Lilly said An injectable drug being tested helps patients achieve a weight loss rate of 22.5%. More details have been released June 4.

“We don’t view Wegove as a competitor,” said Laider, of Gilesys.

Leader does not see over-the-counter weight loss products as competitors.

Lieder said Gelesis sought FDA approval for the treatment, rather than an over-the-counter condition, because “there is a whole wall of supplements and products” and “we felt it was very important to do the study and scientifically prove that it worked.” He added that in The future, “Once we build the brand,” Gillys can seek over-the-counter status.

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

However, 40% of the trial participants did not succeed.

“If you’ve taken it for two months and haven’t lost weight, it may not be the right treatment for you,” Lieder said.

Patients can request relief from their doctors. In a move meant to set it apart from other treatments, Gelesis offers potential patients another option: to skip an office visit entirely by ordering the treatment online. It has partnered with Ro, a direct-to-patient platform, whose network of affiliated physicians provides online health assessments and offers treatment to eligible clients. Ro is also a filebig buyer From Plenty, submitting a $30 million prepaid order in late 2021.

Ro, originally called Roman, launched in 2017 and initially focused on men’s health concerns, including erectile dysfunction and hair loss. It has since expanded to include other conditions.

Online visits with doctors through Ro are free, including weight loss visits. Patients should answer questions about their health and experiences in trying to lose weight, and pregnant patients, people under the age of 22, and those allergic to Plenty’s ingredients should not take it.

Information provided to Ro is not protected under a federal privacy law called the Health Insurance Portability and Accountability Act, or HIPAA, but CEO Zacharias Retano said all data is stored in “HIPAA compliant” ways.

Ro Plenity added to his offerings because of clinical trial results and because he saw a business opportunity with weight loss. Ritano said that help with his “weight management challenges” was one of the most important items his clients requested.

Although his insurance plan doesn’t cover it, patient Renee Morales said the $98 a month he spends is worth it. “If you spend it [much] Over coffee, I can spend it for my health, said the 51-year-old, the president of a skateboard company in Montclair, Calif., that Giles made available for an interview.

He started getting Plenty in late January after his doctor brought it up during his annual medical checkup. Morales said he’s lost 15 pounds from his original 280 pounds and wants to continue the treatment until he’s dropped 30 pounds.

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

Kaiser Health NewsThis article was reprinted from Courtesy of the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization not affiliated with Kaiser Permanente.