A study to test survodutide in people with NASH/MASH cirrhosis
Research type
Research Study
Full title
A Phase III double-blind, randomised, placebo-controlled trial to evaluate liver-related clinical outcomes and safety of once weekly injected survodutide in participants with compensated non-alcoholic steatohepatitis/metabolic dysfunction associated steatohepatitis (NASH/MASH) cirrhosis
IRAS ID
1010427
Contact name
Medical Information N/A
Contact email
Sponsor organisation
Boehringer Ingelheim International GmBH
Research summary
This study, conducted by Boehringer Ingelheim, aims to test whether a medicine called survodutide can help individuals who are at least 18 years old, have a confirmed diagnosis of a liver disease known as non-alcoholic steatohepatitis (NASH)/metabolic-associated steatohepatitis (MASH) and who have cirrhosis.
NASH/MASH cirrhosis is a progressive condition characterised by liver damage without excessive alcohol consumption as the primary cause. It is often associated with obesity, high blood pressure, and high cholesterol. It is becoming more common worldwide and has very limited treatment options. Management of the condition involves lifestyle modifications such as weight loss, physical activity and dietary changes.
Participants are put into 2 groups by chance: one group receives survodutide, while the other receives a placebo. The placebo resembles survodutide but does not contain any active medication. Participants have twice the chance of receiving the study medicine. Both participants and doctors are unaware of which group they belong to. Participants inject survodutide or placebo under their skin once a week. The survodutide doses are slowly increased until the target dose is reached. Participants visit their doctors regularly or get video calls at home.
The study duration is up to 4.5 years. Approximately 1590 participants are expected to take part across 450 hospitals and 40 countries. Doctors monitor participants' safety carefully, collect information about health, take blood samples, measure the liver and record any problems. All participants in the study will receive counselling on diet and exercise. The hope is that survodutide, taken once a week, will improve liver health and reduce the risk of death in participants with this condition.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
24/SC/0261
Date of REC Opinion
1 Nov 2024
REC opinion
Further Information Favourable Opinion