A randomized, double-blind, placebo-controlled study of Gelesis100: A novel nonsystemic oral hydrogel for weight loss
Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
Standard
A randomized, double-blind, placebo-controlled study of Gelesis100 : A novel nonsystemic oral hydrogel for weight loss. / 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.
I: Obesity, Bind 27, Nr. 2, 2019, s. 205-216.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
Harvard
APA
Vancouver
Author
Bibtex
}
RIS
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 -
ID: 208905561