ClinicalTrials16 Apr 2026·Phase 3● 7/10i 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
Boehringer Ingelheim
Boehringer Ingelheim is testing survodutide, a once-weekly injectable, in people with compensated NASH/MASH cirrhosis in a phase 3 trial targeting liver-related clinical outcomes. The randomized, placebo-controlled study aims to enroll 1,590 participants over 4.5 years, measuring time to death, liver transplant, hepatic decompensation, or disease progression. This represents Boehringer's entry into the competitive NASH space where Novo Nordisk's semaglutide is already in phase 3 trials for non-cirrhotic NASH. The trial focuses on advanced cirrhotic patients, a population with high unmet need but challenging regulatory pathway.
Strategic signal
Boehringer positions survodutide against established GLP-1 players in NASH, targeting the most severe patient population where liver-related events drive regulatory approval but commercial adoption faces reimbursement hurdles. The 4.5-year event-driven design mirrors cardiovascular outcome trials, suggesting Boehringer anticipates FDA requiring hard clinical endpoints rather than histologic improvement. This strategy differentiates from Novo's non-cirrhotic NASH approach with semaglutide, potentially creating distinct market segments based on disease severity and specialist referral patterns.
Original Abstract
This study is open to adults who are at least 18 years old and have:
* A confirmed liver disease called non-alcoholic steatohepatitis (NASH) or
* A confirmed liver disease called metabolic-associated steatohepatitis (MASH)
* BMI of 27 kg/m2 or more or
* 25 kg/m2 or more if the participant is Asian.
People with a history of other chronic liver diseases or high alcohol intake cannot take part in this study. The purpose of this study is to find out whether a medicine called survodutide helps people with NASH or MASH improve their liver function.
Participants are put into 2 groups randomly, which means by chance. 1 group gets survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Each participant has twice the chance of getting survodutide. Participants and doctors do not know who is in which group. Participants inject survodutide or placebo under their skin once a week. All participants regularly receive counselling to make changes to their diet and to exercise regularly.
Participants are in the study for up to 4 and a half years. During this time, they visit the study site or have a remote visit by video call every 2, 4 or 6 weeks for about a 1 year and 5 months. After this time participants visit the trial site or have a remote visit every 3 months until the end of the study.
The doctors check participants' health and take note of any unwanted effects. The participants' body weight is regularly measured. At some visits the liver parameters are measured using different imaging methods. The participants also fill in questionnaires about their symptoms. The results are compared between the groups to see whether the treatment works. | Condition(s): Metabolic Dysfunction Associated Steatohepatitis | Primary endpoint(s): Time to first occurrence of any component of the composite clinical endpoint (at EoS) consisting of: all-cause mortality, liver transplant, hepatic decompensation events, worsening of MELD score to ≥15 and progression to CSPH | Enrollment: 1,590 (estimated) | Phase: Phase 3 | Sponsor: Boehringer Ingelheim | Expected completion: 2029-06-05 | Status: Recruiting | Last update: 2026-04-16