NCT02652962

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

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Gelesis, Inc. · Industry
• Sex: Male
• Age: 22 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Healthy Overweight Obese

Interventions

Type	Name	Description
DEVICE	Gelesis200	3 capsules each containing 0.70 g
OTHER	Placebo	3 capsules each containing 0.57 g of a mixture of microcrystalline cellulose and maltodextrin in a ratio of approximately 50 ± 10%

Timeline

• Start date: 2016-01-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2016-01-12
• Last updated: 2016-05-09

Locations

1 site across 1 country: Canada