A Randomized, Double‐Blind, Placebo‐Controlled Study of Gelesis100: A Novel Nonsystemic Oral Hydrogel for Weight Loss. Issue 2 (13th November 2018)

• Record Type: Journal Article
• Authors: Greenway, Frank L.; Aronne, Louis J.; Raben, Anne; Astrup, Arne; Apovian, Caroline M.; Hill, James O.; Kaplan, Lee M.; Fujioka, Ken; Matejkova, Erika; Svacina, Stepan; Luzi, Livio; Gnessi, Lucio; Navas‐Carretero, Santiago; Alfredo Martinez, J.; Still, Christopher D.; Sannino, Alessandro; Saponaro, Cosimo; Demitri, Christian; Urban, Lorien E.; Leider, Harry; Chiquette, Elaine; Ron, Eyal S.; Zohar, Yishai; Heshmati, Hassan M.
• Is Part Of: Obesity. Volume 27:Issue 2(2019)
• Page Start: 205
• Page End: 216
• Publication Date: 2018-11-13
• Subjects: Obesity -- Periodicals; 616.398005
• DOI: 10.1002/oby.22347
• Languages: English
• ISSNs: 1930-7381

Abstract

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/m 2 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.