TY - JOUR
T1 - A Randomized, Double-Blind, Placebo-Controlled Study of Gelesis100
T2 - A Novel Nonsystemic Oral Hydrogel for Weight Loss
AU - Greenway, Frank L.
AU - Aronne, Louis J.
AU - Raben, Anne
AU - Astrup, Arne
AU - Apovian, Caroline M.
AU - Hill, James O.
AU - Kaplan, Lee M.
AU - Fujioka, Ken
AU - Matejkova, Erika
AU - Svacina, Stepan
AU - Luzi, Livio
AU - Gnessi, Lucio
AU - Navas-Carretero, Santiago
AU - Alfredo Martinez, J.
AU - Still, Christopher D.
AU - Sannino, Alessandro
AU - Saponaro, Cosimo
AU - Demitri, Christian
AU - Urban, Lorien E.
AU - Leider, Harry
AU - Chiquette, Elaine
AU - Ron, Eyal S.
AU - Zohar, Yishai
AU - Heshmati, Hassan M.
PY - 2018/1/1
Y1 - 2018/1/1
N2 - 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.
AB - 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.
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U2 - 10.1002/oby.22347
DO - 10.1002/oby.22347
M3 - Article
C2 - 30421844
AN - SCOPUS:85056384369
JO - Obesity
JF - Obesity
SN - 1930-7381
ER -