A study to test survodutide in people with NASH/MASH F2/F3 fibrosis
Research type
Research Study
Full title
A randomised, double-blind, placebo-controlled, multicentre, Phase III trial evaluating long-term efficacy and safety of survodutide weekly injections in adult participants with non-cirrhotic non-alcoholic steatohepatitis/metabolic associated steatohepatitis (NASH/MASH) and (F2) - (F3) stage of liver fibrosis
IRAS ID
1010426
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 medication 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 moderate or advanced liver fibrosis. NASH/MASH 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. Currently there are very limited available medications to treat NASH/MASH. Management of the condition involves lifestyle modifications such as weight loss, physical activity and dietary changes. The study consists of two parts. The first aims to determine the effect of survodutide on NASH/MASH and liver fibrosis, while the second assesses the safety and effectiveness of survodutide in improving liver function. Approximately 1800 participants are expected to take part across 450 hospitals and 40 countries. Participants are randomly assigned to one of two groups: one group receives survodutide, while the other receives a placebo. The placebo resembles survodutide but does not contain any active medication. Both participants and doctors are unaware of which group they belong to. Participants are given survodutide or placebo through injections under the skin once a week. The dosage of survodutide is gradually increased until the target dose is reached. All participants receive counseling on dietary changes and regular exercise. The study duration is up to 7 years. Participants have regular visits to the study site or remote video call visits. Doctors monitor participants' health and body weight, record any unwanted effects and assess the impact on the stomach, intestines and liver. At 2 or 3 visits, doctors take a small sample of liver tissue (biopsy). Participants also complete questionnaires about their symptoms and quality of life.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
24/SC/0260
Date of REC Opinion
1 Nov 2024
REC opinion
Further Information Favourable Opinion