FDA Clears Plenity Hydrogel Capsules for Weight Management

Troy Brown, RN

April 16, 2019

The US Food and Drug Administration (FDA) has cleared Gelesis100 (Plenity, Gelesis) for weight management in adults with a body mass index (BMI) of 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.

The definition of overweight is a BMI of 25 kg/m2 and over, and obesity is defined as 30 kg/m2 and over.

"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 scientific data supporting Plenity's positive effects on weight make it a powerful tool to help with weight management. The most compelling aspects of this approach are its effectiveness, novel mechanism of action and impressive safety data. This approach creates another arm in the treatment algorithm of weight management and could be used by an overwhelming majority of people struggling with weight issues," Fujioka explained.

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 and ≤ 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.

The company plans to launch the product in the second half of 2019.

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