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

N1 - CURIS 2019 NEXS 042

PY - 2019

Y1 - 2019

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.

U2 - 10.1002/oby.22347

DO - 10.1002/oby.22347

M3 - Journal article

C2 - 30421844

VL - 27

SP - 205

EP - 216

JO - Obesity

JF - Obesity

SN - 1930-7381

IS - 2

ER -