Obesity Clinical Trial
Official title:
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
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
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).
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