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 |
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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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