Still, C.D. (Christopher D.)

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    A randomized, double-blind, placebo-controlled study of gelesis100: A novel nonsystemic oral hydrogel for weight loss
    (Wiley, 2019) Gnessi, L. (Lucio); Martinez, J.A. (José Alfredo); Fujioka, K. (Ken); Luzi, L. (Livio); Zohar, Y. (Yishai); Sannino, A. (Alessandro); Heshmati, H.M. (Hassan M.); Apovian, C.M. (Caroline M.); Aronne, L.J. (Louis J.); Svacina, S. (Stephan); Hill, J.O. (James O.); Raben, A. (Anne); Saponaro, C. (Cosimo); Astrup, A. (Arne); Chiquette, E. (Elaine); Ron, E.S. (Eyal S.); Still, C.D. (Christopher D.); Greenway, F.L. (Frank L.); Navas-Carretero, S. (Santiago); Matejkova, E. (Erika); Leider, H. (Harry); Urban, L.E. (Lorien E.); Kaplan, L.M. (Lee M.); Demitri, C. (Christian)
    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.