Gelesis G-04 study
Research type
Research Study
Full title
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Assessing the Effect of Gelesis100 on Body Weight in Overweight and Obese Subjects with and without Type 2 Diabetes
IRAS ID
206014
Contact name
Eyal S. Ron
Contact email
Sponsor organisation
Gelesis Inc.
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 3 months, 31 days
Research summary
Is Gelesis100 effective in reducing body weight in Overweight and Obese Subjects with and without Type 2 Diabetes?
This research study is designed to assess the safety and performance of a new medical device in reducing body weight for people who are overweight or obese. It is an investigational device, which means it is not approved yet. Results of a previous study in humans show that the device has the potential to reduce body weight and improve blood sugar in people who are overweight or obese.
The medical device in question (administered in standard gelatin capsules) is capable of absorbing water solutions up to 100 times its original weight in the gastrointestinal environment. The device hydrates in the stomach and converts a volume of liquids into a volume of small, distinct gel particles. The hydrated gel particles mix with ingested foods, creating a larger volume, reducing appetite and food intake, thereby contributing to weight reduction.
This study is funded by Gelesis srl. and it is conducted as a randomized, double-blind, placebo-controlled, parallel-group study in approximately 38 medical centers in North America and Europe (3 centers in the UK: Liverpool, Bristol and Swansea), with approximately 460 participating adult men and women, whose participation in this study is expected to last up to 31 weeks. After a screening period, the participant subjects will be assigned to receive either the active product (1 chance out of 2) at the amounts of 3 capsules (2.25 g) to be taken twice daily with water 20 to 30 min before lunch and dinner for 24 weeks, or the placebo “inactive product” (1 chance out of 2) to be taken like the active product. The product is assigned randomly (by chance, like the flip of a coin).
REC name
North West - Greater Manchester West Research Ethics Committee
REC reference
16/NW/0575
Date of REC Opinion
16 Aug 2016
REC opinion
Favourable Opinion