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

Research output: Contribution to journalJournal articlepeer-review

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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.

In: Obesity, Vol. 27, No. 2, 2019, p. 205-216.

Research output: Contribution to journalJournal articlepeer-review

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, vol. 27, no. 2, pp. 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., Kaplan, L. M., Fujioka, K., Matejkova, E., Svacina, S., Luzi, L., Gnessi, L., Navas-Carretero, S., Alfredo Martinez, J., Still, C. D., Sannino, A., Saponaro, C., Demitri, C., Urban, L. E., ... 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 et al. 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. In: Obesity. 2019 ; Vol. 27, No. 2. pp. 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