Gelesis200 Safety and Tolerability Study and Effects on Glycemic and Appetite Parameters — STAGE  

Healthy Overweight Obese Clinical Trial

Official title: A Randomized, Double-blind, Placebo-Controlled, 4-Period Study Assessing the Safety, Tolerability and Glycemic and Appetite Effects of Gelesis200 Using Two Different Timings of Administration in Overweight and Obese Subjects

Status Completed

Clinical Trial Summary

The purpose of this study is to determine the safety and tolerability of Gelesis200.

Clinical Trial Description

This is a cross-over within parallel design. Parallel groups will receive Gelesis200 either 2 times or 3 times in one day before meals. Within the parallel groups, subjects will cross-over to 4 arms: A) Gelesis200 10 min before meals, B) Gelesis200 30 min before meals, C) Placebo 10 min before meals, D) Placebo 30 min before meals. Postprandial glucose, insulin and subjective appetite ratings will also be measured. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Overweight Obese
• Overweight

• NCT number: NCT02652962
• Study type: Interventional
• Source: Gelesis, Inc.
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Completion date: March 2016