About 450 overweight or obese adults with BMI 27-40 kg/m2 were randomized to receive Gelesis100 or placebo. Subjects were followed for 6 months. At the end of the trial, patients receiving Gelesis100 lost a significant amount of weight compared to placebo group: about 60% and 25% of the adults lost ≥5% (≥10 lbs) and ≥10% (≥20 lbs) body weight.
Gelesis100 comes in a capsule form. It is taken with plenty of water twice daily before meals. The capsule contains particles, that in the presence of water, have the capability of expanding massively in the stomach, thus triggering a sense of fullness and decreased appetite.
The particles are not absorbed in the bloodstream. No serious adverse events were seen. Gastrointestinal upset was the most common side effect.
The FDA has cleared Gelesis100 (Plenity, Gelesis) for weight management in adults with a BMIof 25 - 40 kg/m2, when used together with diet and exercise, according to a company news release.
The prescription device is a capsule containing hydrogel particles that expand in the stomach after they are ingested but are not systemically absorbed, making the user feel full. They are taken twice daily with water before meals.
"More than 150 million Americans struggle with excess or unhealthy weight. Unfortunately, the majority of individuals with weight issues have important weight-related medical problems. There is no doubt that making a significant impact on this issue should be America's number one public health priority," Ken Fujioka, MD, a weight loss expert and endocrinology researcher at Scripps Clinic and scientific advisor to Gelesis, said in the news release.
The FDA's decision follows consideration of data from a multicenter, double-blind, placebo-controlled pivotal trial that assessed body weight change in 436 adult patients with overweight or obesity (BMI 27-40 kg/m2) after completing 6 months of treatment.
The two predefined coprimary endpoints of the study were 35% or greater percentage of patients in the Plenity group achieving at least a 5% weight loss (categorical endpoint) and placebo-adjusted weight loss with a super-superiority margin of 3%. The researchers also conducted a prespecified analysis of simple superiority.
The trial "met and exceeded the predefined categorical endpoint," with 59% of those in the treatment group experiencing at least a 5% weight loss.
Gelesis100 demonstrated superiority over placebo (–6.4% vs –4.4%; P = .0007) but did not meet the 3% super-superiority endpoint.
Those who received Gelesis100 were twice as likely to achieve at least 5% weight loss when compared with placebo (adjusted odds ratio, 2.0; P = .0008).
More than a quarter (26%) of study completers were "super-responders" to Gelesis100, which the researchers defined as experiencing at least a 10% weight loss. Participants in this group lost an average of 15% or approximately 30 pounds.
Adverse events were similar in the treatment and placebo groups. The most frequently seen treatment-related adverse events were:
Gastrointestinal disorders (38% in the Gelesis100 group vs 28% in the placebo group),
Infections and infestations (1% in each of the Gelesis100 and placebo groups), and
Musculoskeletal and connective tissue disorders (1% in the Gelesis100 group and 0% in the placebo group).
No serious adverse events occurred in the Gelesis100 group and one occurred in the placebo group.