Novel drug may spur weight loss
A novel oral weight-loss therapy led to meaningful weight loss in 58% of adults with obesity in a pivotal study, according to a press release from Gelesis.
The experimental therapy, Gelesis100 (Gelesis) is an oral capsule that contains small hydrogel particles. After ingestion, the capsule dissolve to release the particles in the stomach where they absorb water and expand to about 100 times their original size. The particles mix with food and travel through the gastrointestinal tract to trigger satiety, reduce hunger and cause weight loss.
The Gelesis Loss of Weight Study was a randomized, double-blind, placebo-controlled trial of adults with BMI 27 kg/m2 and 40 kg/m2 (n = 436), including those with prediabetes and type 2 diabetes. Participants were randomly assigned to twice daily 2.25 g of Gelesis100 or placebo. Participants in both arms were assigned a hypocaloric diet and daily physical activity. Follow-up was 6 months.
In those randomized to Gensis100, 58% achieve 5% or more body weight loss compared with 42% in the placebo group (P = .0028). Additionally, 20% of those in the treatment arm lost more than 10% of their body weight compared with 12% in the placebo (P = .027).
The study did not meet its co-primary endpoint of 3% mean difference from placebo.
There was no increased safety risk or adverse event reported, and dropout rate was lower in the treatment arm compared with placebo.
“Based on these results, Gelesis100 could potentially be the treatment we’ve been missing for the patients who need it most,” Frank L. Greenway, MD, chief medical officer at Pennington Biomedical Research Center at the Lousiana State University, said in the release. “Current interventional approaches to weight loss are often invasive and/or have serious side effects.”
The participants are being followed up for an additional 6 months to further assess safety and efficacy.
Gelesis has begun talks with regulatory agencies to assess the feasibility of approval.