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.
MedicalResearch.com: What should readers take away from your report?
Response: More than 130 million Americans struggle with weight loss, making it one of the biggest public health issues facing our society. We believe Gelesis100’s strong safety and efficacy offers a compelling new potential approach to weight loss.
Currently, there are no simple and well-established predictive indicators of response to weight-loss therapeutics, so these findings may identify individuals more likely to be responders. If cleared by the U.S. Food and Drug Administration, Gelesis100 could be an important addition to the clinical toolkit for treating overweight and obesity.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: Based on these results, we are also studying how the Gelesis hydrogel technology may modulate metabolic and inflammatory systems in a number of conditions related to gut barrier dysfunction including non-alcoholic fatty liver disease (NAFLD), non-alcoholic steatohepatitis (NASH), and inflammatory bowel disease (IBD).
Additionally, we are conducting a proof-of-concept study for our second candidate, Gelesis200, which is optimized for weight loss and glycemic control in patients with type 2 diabetes and prediabetes.
MedicalResearch.com: Is there anything else you would like to add?
Response: Gelesis100 is a non-systemic, superabsorbent hydrogel in development for the potential treatment of overweight or obesity. It is made from two naturally derived building blocks, modified cellulose cross-linked with citric acid, that create a three-dimensional matrix. Orally administered in capsules with water before a meal, Gelesis100 particles rapidly absorb water in the stomach and homogenously mix with ingested foods. When hydrated, Gelesis100 occupies about one-fourth of the average stomach volume. Rather than forming one large mass, it creates thousands of small individual gel pieces with the elasticity (firmness) of solid ingested foods (e.g., vegetables) without caloric value. Gelesis100 maintains its three-dimensional structure and mechanical properties during transit through the small intestine. Once it arrives in the large intestine, the hydrogel is partially broken down by enzymes and loses its three-dimensional structure along with most of its absorption capacity. The released water is reabsorbed in the large intestine, and the remaining cellulosic material is expelled in the feces.
A Randomized, Double‐Blind, Placebo‐Controlled Study of Gelesis100: A Novel Nonsystemic Oral Hydrogel for Weight Loss
Obesity ( IF 4.042 ) Pub Date : 2018-11-13 , DOI: 10.1002/oby.22347
Frank L. Greenway; Louis J. Aronne; Anne Raben; Arne Astrup; Caroline M. Apovian; James O. Hill; Lee M. Kaplan; Ken Fujioka; Erika Matejkova; Stepan Svacina; Livio Luzi; Lucio Gnessi; Santiago Navas‐Carretero; J. Alfredo Martinez; Christopher D. Still; Alessandro Sannino; Cosimo Saponaro; Christian Demitri; Lorien E. Urban; Harry Leider; Elaine Chiquette; Eyal S. Ron; Yishai Zohar; Hassan M. Heshmati
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