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/m 2 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.

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. - ISSN 1930-7381. - 27:2(2019), pp. 205-216. [10.1002/oby.22347]

A randomized, double-blind, placebo-controlled study of gelesis100. A novel nonsystemic oral hydrogel for weight loss

Gnessi, Lucio;SANNINO, ALESSANDRO;
2019

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/m 2 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.
2019
medicine (miscellaneous); endocrinology, diabetes and metabolism; endocrinology; nutrition and dietetics
01 Pubblicazione su rivista::01a Articolo in rivista
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. - ISSN 1930-7381. - 27:2(2019), pp. 205-216. [10.1002/oby.22347]
File allegati a questo prodotto
File Dimensione Formato  
Greenwaay_Randomized-double-blind_2019.pdf

accesso aperto

Tipologia: Versione editoriale (versione pubblicata con il layout dell'editore)
Licenza: Creative commons
Dimensione 635.1 kB
Formato Adobe PDF
635.1 kB Adobe PDF

I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.

Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11573/1248864
Citazioni
  • ???jsp.display-item.citation.pmc??? 12
  • Scopus 112
  • ???jsp.display-item.citation.isi??? 85
social impact