A randomized, double-blind, placebo-controlled study of Gelesis100: A novel nonsystemic oral hydrogel for weight loss
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- Greenway et al_Obesity_2019_Vol 27(2)_205-216
Forlagets udgivne version, 619 KB, PDF-dokument
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 & 4 andre
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.
|Status||Udgivet - 2019|
CURIS 2019 NEXS 042
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