Active Digestion, Kidneys & Other Organs NIHR-supported project

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

Funder NIHR (part of DHSC)
Recipient organisation NIHR Nottingham Biomedical Research Centre
NIHR support Recorded as supported by this research centre
Period Jan 2025 — Oct 2027

In plain English

AI plain-English summary

A weekly injection of survodutide is being tested in 1,590 people with NASH/MASH cirrhosis to see if it can prevent liver failure and death. NASH/MASH cirrhosis is a scarring of the liver linked to obesity and metabolic problems, not alcohol. It is becoming more common worldwide, yet no drug is currently approved to treat the condition once cirrhosis has developed. Patients are currently limited to lifestyle changes—diet and exercise—which are difficult to sustain and often insufficient to reverse advanced disease. If survodutide proves effective, it would become the first pharmacological treatment for this stage of the disease. The drug works by mimicking a natural hormone that regulates appetite and metabolism, and the trial is designed to measure hard clinical outcomes: whether patients develop liver decompensation, require a transplant, or die. A positive result would give doctors a concrete tool to slow or halt disease progression in a growing patient population that currently has no medical option beyond supportive care. The trial runs for up to 4.5 years across 450 hospitals in 40 countries.

View original technical description
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.

Researchers

Stephen Ryder (Principal Investigator)

Related Research

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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 nonalcoholic steatohepatitis/metabolic dysfunction associated steatohepatitis (NASH/MASH) cirrhosis
BI 1404-0044 A randomised, double-blind, placebo-controlled, multicentre, Phase III trial evaluating long-term efficacy and safety of Survodutide weekly injections in adult participants patients with non-cirrhotic non-alcoholic steatohepatitis/metabolic associated steatohepatitis (NASH/MASH) and (F2) - (F3) stage of liver fibrosis
A randomised, double-blind, placebo-controlled, multicentre, Phase III trial evaluating long-term efficacy and safety of Survodutide weekly injections in adult participants patients with non-cirrhotic non-alcoholic steatohepatitis/metabolic associated steatohepatitis (NASH/MASH) and (F2) - (F3) stage of liver fibrosis
A Double-Blind, Placebo-Controlled Phase 2b Study to Evaluate the Efficacy and Safety of GSK4532990 in Adults with NonAlcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis
NUT-3 Double-blind, randomised, placebo-controlled, phase IIb trial on the efficacy and safety of norursodeoxycholic acid tablets in patients with non-alcoholic steatohepatitis (NASH)

Original classification

Gastrointestinal and Liver Disorders

Plain English summaries and category classifications on this site are generated by AI and may not perfectly reflect the original research.