A randomized, double-blind, placebo-controlled study of Gelesis100: A novel nonsystemic oral hydrogel for weight loss

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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 tidsskriftTidsskriftartikelForskningfagfællebedømt

Harvard

Greenway, FL, Aronne, LJ, Raben, A, Astrup, A, Apovian, CM, Hill, JO, Kaplan, LM, Fujioka, K, Matejkova, E, Svacina, S, Luzi, L, Gnessi, L, Navas-Carretero, S, Alfredo Martinez, J, Still, CD, Sannino, A, Saponaro, C, Demitri, C, Urban, LE, Leider, H, Chiquette, E, Ron, ES, Zohar, Y & Heshmati, HM 2019, 'A randomized, double-blind, placebo-controlled study of Gelesis100: A novel nonsystemic oral hydrogel for weight loss', Obesity, bind 27, nr. 2, s. 205-216. https://doi.org/10.1002/oby.22347, https://doi.org/10.1002/oby.22533

APA

Greenway, F. L., Aronne, L. J., Raben, A., Astrup, A., Apovian, C. M., Hill, J. O., ... Heshmati, H. M. (2019). A randomized, double-blind, placebo-controlled study of Gelesis100: A novel nonsystemic oral hydrogel for weight loss. Obesity, 27(2), 205-216. https://doi.org/10.1002/oby.22347, https://doi.org/10.1002/oby.22533

Vancouver

Greenway FL, Aronne LJ, Raben A, Astrup A, Apovian CM, Hill JO o.a. A randomized, double-blind, placebo-controlled study of Gelesis100: A novel nonsystemic oral hydrogel for weight loss. Obesity. 2019;27(2):205-216. https://doi.org/10.1002/oby.22347, https://doi.org/10.1002/oby.22533

Author

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. / A randomized, double-blind, placebo-controlled study of Gelesis100 : A novel nonsystemic oral hydrogel for weight loss. I: Obesity. 2019 ; Bind 27, Nr. 2. s. 205-216.

Bibtex

@article{35cdc923edac40c5931bc5647e439b33,
title = "A randomized, double-blind, placebo-controlled study of Gelesis100: A novel nonsystemic oral hydrogel for weight loss",
abstract = "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.",
author = "Greenway, {Frank L} and Aronne, {Louis J} and Anne Raben and Arne Astrup and Apovian, {Caroline M} and Hill, {James O} and Kaplan, {Lee M} and Ken Fujioka and Erika Matejkova and Stepan Svacina and Livio Luzi and Lucio Gnessi and Santiago Navas-Carretero and {Alfredo Martinez}, J and Still, {Christopher D} and Alessandro Sannino and Cosimo Saponaro and Christian Demitri and Urban, {Lorien E} and Harry Leider and Elaine Chiquette and Ron, {Eyal S} and Yishai Zohar and Heshmati, {Hassan M}",
note = "CURIS 2019 NEXS 042",
year = "2019",
doi = "10.1002/oby.22347",
language = "English",
volume = "27",
pages = "205--216",
journal = "Obesity",
issn = "1930-7381",
publisher = "Wiley-Blackwell",
number = "2",

}

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