NCT06632457

LIVERAGE™ - Cirrhosis: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Cirrhosis

Recruiting now Phase 3 Last updated 16 April 2026

What this trial tests

Phase 3 trial testing Survodutide in Metabolic Dysfunction Associated Steatohepatitis in 1,590 participants. Currently enrolling.

Timeline

7 November 2024

Primary endpoint
5 June 2029

5 June 2029

Quick facts

Lead sponsor	Boehringer Ingelheim
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	1,590
Start date	7 November 2024
Primary completion	5 June 2029
Estimated completion	5 June 2029
Sites	438 locations across Italy, Jordan, Japan, Malaysia, Kazakhstan, Taiwan, Poland, South Korea

Drugs / interventions tested

• Survodutide — full drug profile →
• Placebo matching survodutide — full drug profile →

Conditions studied

• Metabolic Dysfunction Associated Steatohepatitis — all drugs for Metabolic Dysfunction Associated Steatohepatitis →

Sponsor

Boehringer Ingelheim — full company profile →

Who can join

18 and older, any sex, with Metabolic Dysfunction Associated Steatohepatitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Mechanism-guided drug development and treatment for liver fibrosis: a clinical perspective.
   Zeng X, Huang D, Zhu Z, Cai Q, et al · · 2025 · cited 6× · PMID 40492139 · DOI 10.3389/fphar.2025.1574385
2. Obesity-Driven Metabolic Disorders: The Interplay of Inflammation and Mitochondrial Dysfunction.
   Choi W, Woo GH, Kwon TH, Jeon JH. · · 2025 · cited 4× · PMID 41096980 · DOI 10.3390/ijms26199715
3. Innovative Drugs First Implemented in Type 2 Diabetes Mellitus and Obesity and Their Effects on Metabolic Dysfunction-Associated Steatohepatitis (MASH)-Related Fibrosis and Cirrhosis.
   Cazac-Panaite GD, Lăcătușu CM, Grigorescu ED, Foșălău AB, et al · · 2025 · cited 3× · PMID 40004572 · DOI 10.3390/jcm14041042
4. Current Trends and Perspectives on Obesity and Metabolic Dysfunction-Associated Steatohepatitis in East Asia.
   Lim S, Zhou H, Ogawa W. · · 2026 · cited 1× · PMID 41771545 · DOI 10.7570/jomes25083
5. How does survodutide work? Plain language review of a potential new medication for obesity and liver disease
   Almandoz J, Miras A, Seufert J, Paul E. · · 2026
6. Current Drug Development Pipeline for MASLD and MASH: Focusing on Cardiovascular Comorbidities.
   Prikhodko VA, Okovityi SV. · · 2026 · PMID 42072449 · DOI 10.3390/biomedicines14040909
7. Metabolic dysfunction associated steatotic liver disease: mechanisms, diagnosis, and management in adults.
   Reinson T, Bilson J, Childs C, Buchanan RM, et al · · 2026 · PMID 41947908 · DOI 10.1136/bmjmed-2025-002038
8. Management of obesity in advanced chronic liver disease.
   Caussy C, Francque SM. · · 2026 · PMID 41810426 · DOI 10.1016/j.jhepr.2026.101749