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Research type
Research Study
Full title
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Assessing the Effect of GS300 on Nonalcoholic Fatty Liver Disease
IRAS ID
300586
Contact name
Mahadev Ramjee
Contact email
Sponsor organisation
Gelesis, Srl.
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 2 months, 11 days
Research summary
Nonalcoholic fatty liver disease (NAFLD) is a condition that can be characterised by the additional fat build-up in the liver, without a clear cause for the build-up such as alcohol, virus, or medicine. When left untreated, NAFLD can sometimes develop into liver cirrhosis (additional scarring in the liver, slowing down its ability to function) or liver cancer.
NAFLD affects about 20% of the population. Those affected often have one or more components of metabolic syndrome such as obesity, systemic hypertension, dyslipidemia and insulin resistance/overt diabetes. To date, drug treatments have proven to be ineffective largely disappointing or unappealing due to side effects, with no drug outperforming the impact of weight loss. The most common treatments typically involve diet and weight loss therapy. However, most patients cannot achieve or sustain weight loss, thus there is an urgent need for safe and effective therapies to treat NAFLD and related issues of obesity and metabolic syndrome.
The purpose of this research study is to test the safety, tolerability and effectiveness of the GS300 study device in reducing weight and the amount of fat in the liver. GS300 capsules, when taken before a meal, is homogeneously mixed with ingested food, increasing the elasticity of the stomach and small intestine contents. This in turn may induce satiety, which reduces food intake.It is hypothesized that GS300 can help patients achieve significant weight loss, potentially decrease intestinal permeability, and insulin resistance, and correct the microbiome disruption that could result in liver fat reduction.
This is a double-blind, randomised, placebo-controlled study where the effects of GS300 will be compared to the effects of placebo in ~250 participants from roughly 35 clinical sites in the UK, US and EU. Participants in the study will be randomly assigned to receive GS300 or placebo 2 times per day prior to meals for 24 weeks.
REC name
London - Queen Square Research Ethics Committee
REC reference
21/LO/0807
Date of REC Opinion
3 Nov 2021
REC opinion
Unfavourable Opinion