LIGHT-UP: Loss of weight in prediabetes and type 2 diabetes
Research type
Research Study
Full 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
IRAS ID
211176
Contact name
John Wilding
Contact email
Sponsor organisation
Gelesis, Srl.
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Overweight and obesity are major health problems worldwide, responsible for increased mortality and morbidity including cancers, heart disease, high blood pressure and Type 2 diabetes. Type 2 diabetes is characterised by high blood sugar levels due to the body being unable to produce enough insulin or respond to insulin (a hormone which regulates blood sugar levels). Type 2 diabetes can cause serious long-term health problems, including blindness and kidney disease. Almost 90% of people living with Type 2 diabetes are overweight or obese.
Lifestyle changes such as a low calorie diet and exercise are vital to encourage weight loss and to prevent or delay the onset of type 2 diabetes in the overweight and obese. Success of these options however can be limited by access to healthy food choices and safe environment for lifestyle intervention, variable tolerability, and poor compliance. There is an unmet need for a product that is easy to use, convenient, accessible and effective at inducing and sustaining weight loss in patients who are at high risk of developing diabetes.
Gelesis, Srl. have developed a new medical device, Gelesis200, which has been designed to induce satiety and reduce food intake to allow safe and effective weight loss and improve blood sugar control.
This study is being done to see if Gelesis200 can promote weight loss in overweight and obese patients with prediabetes or type 2 diabetes.
This is a multicentre study, which will take place across Europe and United States. It is anticipated that approximately 420 participants will be enrolled worldwide.
This is a double-blind, randomised, placebo-controlled study meaning that participants will be randomly assigned to receive Gelesis200 alone, Gelesis200 and placebo (‘dummy drug’ with no active ingredient), or placebo alone three times a day orally for 24 weeks. Neither the participant nor the study doctor will know which capsules are being given.REC name
London - West London & GTAC Research Ethics Committee
REC reference
17/LO/0447
Date of REC Opinion
21 Jun 2017
REC opinion
Further Information Favourable Opinion