NCT03058029

Effect of Gelesis200 on Body Weight in Overweight and Obese Subjects w/o Type 2 Diabetes

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Assessing the Effect of Gelesis200 on Body Weight in Overweight and Obese Subjects Without or With Type 2 Diabetes

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Gelesis, Inc. · Industry
• Sex: All
• Age: 22 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Assessing the Effect of Gelesis200 on Body Weight in Overweight and Obese Subjects without or with Type 2 Diabetes

Detailed description

Multicenter, two-cohort, randomized, double-blind, placebo-controlled, parallel-group, fixed-dose, adaptive (Two Phases). In the first Phase of the adaptive design, unblinded interim analyses were conducted on 57 subjects and used to adjust the design for the second Phase. The first Phase was completed under protocol Version 1.0. Data used in the unblinded interim analyses of the first Phase will not be included in the second Phase (protocol Version 2.0 and subsequent protocol versions) analyses. The study will evaluate the safety, tolerability and efficacy of Gelesis200 as a superabsorbent hydrogel for weight loss in treated diabetic subjects, untreated diabetic subjects, and prediabetic subjects (Cohort 1). The study will evaluate separately the safety, tolerability and efficacy of Gelesis200 for weight loss in normoglycemic subjects (Cohort 2).

Conditions

• Overweight
• Diabetes
• PreDiabetes
• Obesity

Interventions

Type	Name	Description
DEVICE	Gelesis200	Subject would take Gelesis200 capsules 2 times per day.
DEVICE	Placebo	Subject would take placebo capsules 2 times per day.

Timeline

• Start date: 2017-02-22
• Primary completion: 2021-01-15
• Completion: 2021-01-15
• First posted: 2017-02-20
• Last updated: 2020-07-21

Locations

30 sites across 8 countries: United States, Canada, Czechia, Denmark, Hungary, Italy, Poland, United Kingdom

Regulatory

• FDA-regulated device study