A Randomized, Double‐Blind, Placebo‐Controlled Study of Gelesis100: A Novel Nonsystemic Oral Hydrogel for Weight Loss

Autor: Livio Luzi, Louis J. Aronne, Yishai Zohar, Elaine Chiquette, Lee M. Kaplan, Erika Matejkova, James O. Hill, Anne Raben, Ken Fujioka, Christopher D. Still, J. Alfredo Martínez, Arne Astrup, Hassan Heshmati, Cosimo Saponaro, Alessandro Sannino, Lorien E. Urban, Christian Demitri, Stepan Svacina, Caroline M. Apovian, Eyal S. Ron, Harry Leider, Santiago Navas-Carretero, Frank L. Greenway, Lucio Gnessi
Přispěvatelé: 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., Leider, H., Chiquette, E., Ron, E. S., Zohar, Y., Heshmati, H. M.
Rok vydání: 2018
Předmět:
Male
medicine.medical_specialty
Endocrinology
Diabetes and Metabolism
Placebo-controlled study
Administration
Oral
Medicine (miscellaneous)
030209 endocrinology & metabolism
Type 2 diabetes
Overweight
Placebo
Gastroenterology
The Gelesis Loss Of Weight (GLOW)
law.invention
03 medical and health sciences
0302 clinical medicine
Endocrinology
Double-Blind Method
Randomized controlled trial
law
Weight loss
Diabetes mellitus
Internal medicine
Weight Loss
medicine
Obesity
030212 general & internal medicine
Clinical Trials and Investigations
medicine (miscellaneous)
endocrinology
diabetes and metabolism
endocrinology
nutrition and dietetics
Nutrition and Dietetics
business.industry
Superabsorbent hydrogel
Original Articles
Middle Aged
Placebo-controlled
medicine.disease
Hydrogel
Tolerability
Female
Original Article
medicine.symptom
business
Human
Zdroj: Obesity (Silver Spring, Md.)
Dadun. Depósito Académico Digital de la Universidad de Navarra
Consejo Superior de Investigaciones Científicas (CSIC)
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, Leider, H, Chiquette, E, Ron, E S, Zohar, Y & Heshmati, H M 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
ISSN: 1930-739X
1930-7381
Popis: 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.
Databáze: OpenAIRE
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