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

Phase 3

Recruiting

• Conditions: Metabolic Dysfunction Associated Steatohepatitis
• Interventions: Drug: Survodutide; Drug: Placebo matching survodutide

• Registration Number: NCT06632457
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-08
• Study First Submitted QC: 2024-10-08
• Study First Posted: 2024-10-09
• Study Start: 2024-11-12
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-20
• Last Update Posted: 2024-12-24
• Primary Completion: 2029-06-05
• Study Completion: 2029-06-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1590

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Survodutide	Survodutide	-
Placebo	Placebo matching survodutide	-

Primary Outcome Measures

Name	Time	Method
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	up to 4.5 years.	MELD = model of end-stage liver disease CSPH = Clinically significant portal hypertension

Secondary Outcome Measures

Name	Time	Method
Absolute change from baseline in enhanced liver fibrosis (ELF) score	At baseline and at Week 76.
Percentage change from baseline in body weight	At baseline and at Week 76.
Absolute change from baseline in glycosylated haemoglobin A1c (HbA1c) in participants with type 2 diabetes mellitus (T2DM) at baseline (%)	At baseline and at Week 76.
Absolute change from baseline in HbA1c in participants with T2DM at baseline (mmol/mol)	At baseline and at Week 76.
Absolute change from baseline in liver stiffness in FibroScan® vibration-controlled transient elastography (VCTE) (kPa)	At baseline and at Week 76.
Percentage change from baseline in liver stiffness in FibroScan® VCTE	At baseline and at Week 76.
Time to first occurrence of progression to CSPH	up to 4.5 years.
Time to first occurrence of any of the hepatic decompensation events (ascites, HE, or portal hypertension-related upper GI bleeding), or worsening of MELD score to ≥15	up to 4.5 years.
Occurrence of all-cause hospitalisation (first and recurrent)	up to 4.5 years.
Time to first occurrence of any of the adjudicated components of the composite endpoint 5-point major adverse cardiac event (5P-MACE)	up to 4.5 years.
Absolute changes from baseline in lipids (mg/dL)	At baseline and at Week 76.
Absolute change from baseline in aspartate aminotransferase (AST) (U/L)	At baseline and at Week 76.
Absolute change from baseline in alanine aminotransferase (ALT) (U/L)	At baseline and at Week 76.
Absolute change from baseline in liver stiffness assesses by magnetic resonance elastography (MRE)	At baseline and at Week 76.

Trial Locations

Locations (9)

Scottsdale Clinical Trials; 🇺🇸 Scottsdale, Arizona, United States

Synergy Healthcare; 🇺🇸 Brandon, Florida, United States

Optimus U Corporation-Miami-69452; 🇺🇸 Miami, Florida, United States

FQL Research LLC; 🇺🇸 Miramar, Florida, United States

Omega Research Orlando, LLC; 🇺🇸 Orlando, Florida, United States

Digestive Research Alliance of Michiana; 🇺🇸 South Bend, Indiana, United States

Delta Research Partners, LLC; 🇺🇸 Monroe, Louisiana, United States

Advanced Research Institute-Ogden-57845; 🇺🇸 Ogden, Utah, United States

Velocity Clinical Research-Seattle-69881; 🇺🇸 Seattle, Washington, United States