Gelesis100 Hydrogel In Development For Weight Loss and Obesity

MedicalResearch.com Interview with:
Gelesis, Inc.H.M. Heshmati, M.D.

Executive Vice President, Endocrinology and Metabolism
Gelesis, Inc.

 MedicalResearch.com: What is the background for this study? What are the main findings? 

Response: The Gelesis Loss Of Weight (GLOW) clinical study is a pivotal, multicenter, double-blind, placebo-controlled study of our lead investigational product candidate, Gelesis100, which is an oral, non-systemic approach to weight loss. The GLOW study was designed to assess change in body weight in adults with overweight or obesity after six months of treatment with Gelesis100.

Main findings from the GLOW study include the following:

  • 59% of Gelesis100-treated adults achieved weight loss of at least 5% over six months.

o   The new data show that Gelesis100-treated adults fell into two groups: responders, the 6 out of 10 who lost an average of 10% of their total body weight (about 22 pounds) and nearly 4 inches from their waist circumference. Non-responders, the 4 out of 10 who lost an average of 1% of their total body weight (about 2 pounds).

o   The complete Gelesis100 treatment group (including both responders and non-responders) demonstrated superiority compared to placebo (–6.4% vs. –4.4%, P=0.0007)

  • Successful response to Gelesis100 may be predicted by elevated fasting plasma glucose at baseline or weight loss as early as week 8.
  • There was a clear and early separation between responders and non-responders. More specifically, weight loss of at least 3% as early as after eight 8 weeks of treatment predicted clinically meaningful weight loss at six months, with sensitivity and specificity levels exceeding 80%.
  • The study also showed that nearly half of the adults with prediabetes or drug-naive type 2 diabetes were super-responders. These individuals, who typically face greater challenges to lose weight, had six times greater odds of being super-responders, compared to placebo (adjusted OR: 6.1, P=0.0071).
  • Gelesis100 had a highly favorable safety and tolerability profile. 

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OPTIFAST Total Meal Replacement Plan Supported Significant Weight Loss

MedicalResearch.com Interview with:

Dr. Jamy Ard MD Professor of Epidemiology and Prevention Co-director,the Wake Forest Baptist Health Weight Management Center Wake Forest School of Medicine

Dr. Ard

Dr. Jamy Ard MD
Professor of Epidemiology and Prevention
Co-director,the Wake Forest Baptist Health Weight Management Center
Wake Forest School of Medicine

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Obesity continues to be a growing health challenge, and doctors need as many resources as possible to help their patients achieve success. The OPTIWIN trial shows that a total meal replacement program like OPTIFAST can help with significant and sustained weight loss.

The OPTIFAST Program is a medically monitored weight loss program that combines meal replacement with behavioral counseling and personalized support. In the OPTIWIN study, participants were randomized to either the OPTIFAST Program (OP) or a behavioral intervention using a food-based diet (FB).

At both 26 and 52 weeks, the OP group lost, on average, twice as much of their initial body weight as the FB group:

  • At 26 weeks: 12.4% (SE 0.6) vs 6.0% (SE 0.6) of body weight lost (OP vs FB, respectively; p<0.001)
  • At 52 weeks: 10.5% (SE 0.6) vs 5.5% (SE 0.6) of body weight lost (OP vs FB, respectively; p<0.001)

Additionally, the proportion of participants who achieved clinically meaningful weight loss (≥5%, ≥10%, and ≥15%) was significantly higher in the OP group. For example:

  • At 26 weeks, 55% of the OP group lost at least 10% of their initial body weight vs 23% of the FB group (p<0.001)
  • At 52 weeks, 44% of the OP group lost at least 10% of their initial body weight vs 22% of the FB group (p<0.001)

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