A Randomized, Double‐Blind, Placebo‐Controlled Study of Gelesis100: A Novel Nonsystemic Oral Hydrogel for Weight Loss

Abstract

Objective This study aims to assess the efficacy and safety of Gelesis100, a novel, nonsystemic, superabsorbent hydrogel to treat overweight or obesity. Methods The Gelesis Loss Of Weight (GLOW) study was a 24‐week, multicenter, randomized, double‐blind, placebo‐controlled study in patients with BMI ≥ 27 and ≤ 40 kg/m2 and fasting plasma glucose ≥ 90 and ≤ 145 mg/dL. The co‐primary end points were placebo‐adjusted weight loss (superiority and 3% margin super‐superiority) and at least 35% of patients in the Gelesis100 group achieving ≥ 5% weight loss. Results Gelesis100 treatment caused greater weight loss over placebo (6.4% vs. 4.4%, P = 0.0007), achieving 2.1% superiority but not 3% super‐superiority. Importantly, 59% of Gelesis100‐treated patients achieved weight loss of ≥ 5%, and 27% achieved ≥ 10% versus 42% and 15% in the placebo group, respectively. Gelesis100‐treated patients had twice the odds of achieving ≥ 5% and ≥ 10% weight loss versus placebo (adjusted OR: 2.0, P = 0.0008; OR: 2.1, P = 0.0107, respectively), with 5% responders having a mean weight loss of 10.2%. Patients with prediabetes or drug‐naive type 2 diabetes had six times the odds of achieving ≥ 10% weight loss. Gelesis100 treatment had no apparent increased safety risks. Conclusions Gelesis100 is a promising new nonsystemic therapy for overweight and obesity with a highly desirable safety and tolerability profile.

The gut-liver axis in liver disease: Pathophysiological basis for therapy

“…Orally administered in capsules with water before a meal, hydrogel particles rapidly absorb water in the stomach and homogeneously mix with ingested foods, but without caloric value. 132 Once hydrated, the ingested dose of hydrogel occupies about one-fourth of the average stomach, mimicking food in terms of volume and thereby improving satiety. It maintains its 3D structure and mechanical properties during transit through the small intestine and once in the large intestine, the hydrogel is partially digested by enzymes and loses its 3D structure along with most of its absorption capacity.…”

“…A significant association was observed between baseline fasting plasma glucose levels and the effectiveness of the treatment, suggesting a benefit for a higherrisk population otherwise known to be less responsive to therapy. 132 Hydrogel is currently being tested in preclinical models 133 and ongoing clinical trials in obese patients with and without type 2 diabetes (NCT03622424 and NCT03058029) (Table 3). Currently, no data are available on the effects of this technology on the liver, although it could prevent or improve NAFLD by inducing weight loss and relieving insulin resistance.…”

Medical and surgical management of obesity and diabetes: what's new?

“…Gelesis 100 is an orally administered hydrogel made from food‐grade cellulose which absorbs water 100 times its dry weight and expands to form an elastic solid in the stomach, giving a sensation of fullness. In a placebo‐controlled study, 436 volunteers with obesity were randomized to three capsules with 500 ml water or placebo, 20 min before a reduced‐calorie meal daily . After 24 weeks, 5% weight loss was achieved by 59% and 42% of participants, and 10% weight loss by 27% and 15% of the participants assigned to hydrogel and placebo, respectively.…”

A Weight Loss Device That Looks Like a Pill

“…In this issue of Obesity , Greenway et al present results of the pivotal trial for Gelesis100, which could be the first approved agent in a new class of medication‐like, noninvasive devices for obesity treatment .…”