New weight loss treatments are characterized by heavy marketing and modest results

The first “Edible Billboard” arrived, which was loaded with cake treats in New York’s East Village during the holidays last year. Then, in late January, comes the national marketing campaign, with TV and digital media promoting the idea that trying to lose weight does not mean that a person cannot enjoy eating.

These advertising messages are pushing a product called Plenity as a possible relief from the suffering of dieters. This is a $ 98-per-month weight loss treatment that looks like a drug: patients take three capsules twice a day. But it is not a drug. And the success of the lost pound rack up, average, modest.

The planet is an FDA-approved instrument containing a sugar-sized grain of a plant-based, absorbent hydrogel. Each grain swells 100 times its size, which collectively fills a quarter of a person’s stomach. The three capsules containing these must 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.

Treatment is not usually covered by insurance.

“We thought we’d lower the price enough for most consumers to pay out of pocket,” said Dr. Harry Lider, chief medical officer and executive vice president of Jealousy, the creator of Pliny.

Although some prescriptions are much less expensive than weight loss treatments, they are “not affordable for anyone with a low-income bracket,” said Jenna Shaw Tronier, an assistant professor of clinical services at the University of Pennsylvania and director of the Weight Loss Center. And eating disorders.

Planetarium is designed to help patients who want to eat less and taking it is comparable to eating a large salad before lunch and dinner without taking actual raw vegetables.

This is compounded by the growing choice of prescription weight loss and obesity treatments, from old school oral medications that often range from low-cost generics to many expensive brand-name injectable diabetes medications that are being revived as new weight loss treatments. Outcomes vary widely among trial participants; Of those who received the planet, 59% lost at least 5% of their body weight, although the rest failed to meet that threshold.

The planet, whose active ingredient is a form of cellulose, adopts a technique that some people have been using for decades: to feel full before eating a main meal, thus reducing the calories they consume. Studies have shown that “if you eat broth-based soup or vegetables before you fill up, you will feel satisfied and eat less,” said Tronier. He noted that filling with water does not produce the same satiety effect.

Still, some patients say they “hate vegetables” and “capsules are too simple,” said Dr. Christina Nguyen, medical director of obesity medicine at Northeast Georgia Health System. He is not associated with Gelesis but has been determining the planet since its soft launch in late 2020.

So far, the Gelisis marketing campaign credits the fact that it helped pick 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 tool for more than 70% of American adults who are overweight or obese?

W. Timothy Garvey, professor and director at the University of Alabama at Birmingham, said: “I’m glad to see it on the market, but I want patients to lose weight more than I do with this device.” University of Diabetes Research Center

Jelisis reports that participants in its clinical trials who used Plenity lost 6.4% of their average weight – above 5% which many doctors say is a good goal threshold. For a 200-pound person, that would be about 13 pounds. Still, it’s a little better than the 4.4% weight loss, on average, people gave a placebo Experienced in six months trial. All 436 participants were placed on a diet that contained 300 calories less per day than they needed to maintain their weight.

Nguyen said he told his patients they must change their eating and exercise habits or the planet would not work. “You have to be realistic and set expectations,” he said. “What I’ve seen with Plenty is about 5% weight loss.”

He noted that it has relatively few side effects – mainly gastrointestinal, such as bloating, nausea, constipation or flatulence – and that the FDA has approved it for use by people with lower body mass index numbers than other prescription products.

Plenity’s average weight loss is less than or equal to some other oral medications, and much lower than the more expensive new additions on the market, such as Novo Nordisk’s Wegovy, an injection once a week that costs $ 1,300 a month. According to clinical trials, Wegovy helped patients lose about 15% of their body weight in 17 months. In April, Eli Lilly said an injectable drug that it was testing would help patients lose an average of 22.5% of their weight. More details were published June 4.

“We don’t see Wegovic as a competitor,” said the leader of Gelasis.

Nor do Leider view weight loss products available without a prescription as competitors.

Ledger said that Gelasis sought FDA prescriptions for treatment rather than over-the-counter status, because “there is a whole wall of nutritional supplements and products” and “we felt it was important to do the research and prove it scientifically.” “Once we’ve built the brand,” Jelisis could ask for over-the-counter status, he added.

Like other treatments, weight loss can vary greatly with plenitis, he noted. Study data show that 27% of those who were treated were considered “super responsive”, losing an average of 14% of their weight. Patients with diabetes or pre-diabetes may respond better than 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 can’t lose weight, it may not be therapy for you,” Leider said.

Patients can request a lot from their doctors. In a move aimed at distinguishing it from other treatments, Galesis offers potential patients another option: to avoid office visits altogether by requesting treatment online. It has partnered with Ro, a direct-to-patient platform that provides a network of its affiliated physicians for online health assessment and treatment to qualified clients. Row a Pliny’s largest buyer is placing $ 30 million in prepaid orders by the end of 2021.

Ro, originally named Roman, was launched in 2017 and initially focused on men’s health concerns, including erectile dysfunction and hair loss. It has been extended to cover other conditions.

Free online visits with physicians through Ro, also for weight loss. Patients must answer questions about their health and experience trying to lose weight. It should not be taken by pregnant patients, persons under 22 years of age and those who are allergic to Plenity’s ingredients.

The information provided to Ro is not protected under the Health Insurance Portability and Accountability Act, or the federal privacy law called HIPAA, but CEO Zakaria Reitano said all data is stored in a “HIPAA-compliant” manner.

Plenity added to Ro’s offers because of the results of clinical trials and seeing a business opportunity with weight loss. Support for the “challenge with weight management” was one of the top items requested by his clients, Reitano said.

Although it is not covered by his insurance plan, patient Renেনে Morales says it is worth spending $ 98 a month. “If I spend [much] In coffee, I can spend it on my health, “said the 51-year-old, who was offered an interview by the president of a skateboard company in Montclair, California, and by Gelesis.

She began taking the planet in late January when her doctor brought it in during her annual physical time. Morales said he has lost about 280 pounds to 15 pounds of his original weight and would like to stay in treatment until he is 30.

Morales said the treatment was helping him rebuild his outlook on food and focus on smaller areas: “I’m here. [the] Realize that you don’t have to submit your plate to enjoy your meal. “

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