Current partner codePEPTIDESDE
NCT06632457·Phase 3·INTERVENTIONAL

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

Status

Recruiting

Phase

Phase 3

Enrollment

1,590

Locations

444

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

COMBINATION_PRODUCT

Survodutide

Subcutaneous injection, pre-filled syringe

COMBINATION_PRODUCT

Placebo matching survodutide

Subcutaneous injection, pre-filled syringe

Timeline

From registration to results.

  1. First posted

    Oct 9, 2024

  2. Study start

    Nov 7, 2024

  3. Primary completion

    Jun 5, 2029

  4. Study completion

    Jun 5, 2029

  5. Results posted

    Not reported

  6. Registry updated

    Jul 9, 2026

Outcomes

What the study measures.

Primary outcomes

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

Time frame · up to 4.5 years.

MELD = model of end-stage liver disease CSPH = Clinically significant portal hypertension

Secondary outcomes

Key secondary endpoint: Absolute change from baseline in enhanced liver fibrosis (ELF) score

Time frame · At baseline and at Week 76.

Key secondary endpoint: Percentage change from baseline in body weight

Time frame · At baseline and at Week 76.

Key secondary endpoint: Absolute change from baseline in glycosylated haemoglobin A1c (HbA1c) (%) in participants with type 2 diabetes mellitus (T2DM) at baseline

Time frame · At baseline and at Week 76.

Key secondary endpoint: Absolute change from baseline in liver stiffness (kPa) in FibroScan® vibration-controlled transient elastography (VCTE)

Time frame · At baseline and at Week 76.

Percentage change from baseline in liver stiffness in FibroScan® VCTE

Time frame · At baseline and at Week 76.

Time to first occurrence of progression to CSPH

Time frame · 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

Time frame · up to 4.5 years.

Occurrence of all-cause hospitalisation (first and recurrent)

Time frame · 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)

Time frame · up to 4.5 years.

Absolute changes from baseline in lipids (mg/dL)

Time frame · At baseline and at Week 76.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

Inclusion criteria: 1. Male or female adults ≥18 years of age at the time of screening, and at least the legal age of consent in countries where it is \>18 years 2. Body mass index (BMI) ≥27 kg/m2(≥25 kg/m2 for Asian trial participants) 3. Compensated metabolic dysfunction-associated steatohepatitis (MASH) cirrhosis. 4. Magnetic resonance imaging proton density fat fraction (MRI-PDFF) fat fraction ≥5% or FibroScan® with controlled attenuation parameter (CAP) ≥288 dB/m, obtained during the screening period or a historic MRI-PDFF ≤12 weeks prior to randomisation (except for patients with 'cryptogenic cirrhosis' where MRI-PDFF \<5% or FibroScan® with CAP \<288 dB/m is allowed). This inclusion criterion does not apply for participants with a recent (≤12 months prior to randomisation) liver biopsy showing steatosis/steatohepatitis. 5. Further inclusion criteria apply. Exclusion criteria: 1. Current or history (\<5 years) of significant alcohol consumption, defined as an average of \>140 g/week in female patients and \>210 g/week in male patients, for a period of \>3 consecutive months, or an inability to reliably quantify alcohol consumption based upon judgment of the investigator. 2. Model of end-stage liver Disease (MELD) score \>12 due to liver disease 3. History or current (i.e. at screening) hepatic decompensation event of any of the following but not limited to: * Portal hypertension-related upper gastrointestinal (GI) bleeding * Ascites * Hepatic encephalopathy (HE) ≥Grade 1 according to the West Haven criteria 4. Any of the following lab test result at screening * Albumin below \<3.5 g/dL (\<35.0 g/L) * International normalised ratio (INR) \>1.3 unless due to therapeutic anticoagulants * Total bilirubin (TBL) \>1.2x upper limit of normal (ULN) NOTE: Trial participants with Gilbert Syndrome are eligible with a TBL \>1.2x ULN if reticulocyte count is within normal limits, haemoglobin is within normal limits unless due to chronic anaemia and unrelated to haemolysis, and direct bilirubin is \<20% of TBL. * Alkaline phosphatase \>1.5x ULN * PLT \<100,000/µL (\<100 GI/L) 5. History or evidence of other chronic liver diseases, such as primary biliary cholangitis, primary sclerosing cholangitis, autoimmune hepatitis or overlap syndrome, Wilson's disease, alpha-1-antitrypsin deficiency, or genetic haemochromatosis 6. Hepatitis B positive (defined as positive hepatitis B surface antigen (HBsAg)) or history of chronic HBV infection 7. Hepatitis C positive (defined as positive hepatitis C virus (HCV) antibody and a positive HCV ribonucleic acid (RNA)) 8. Serum aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \>5x ULN 9. Evidence of alcoholic liver disease, or drug-induced liver disease, as defined on the basis of typical exposure and history 10. History of liver transplantation or listed for liver transplantation 11. History of transjugular intrahepatic portosystemic shunt (TIPS) or other radiological/surgical procedure for portal hypertension treatment 12. Further exclusion criteria apply

Study locations

444 registered sites.

Argentina · Australia · Austria · Belgium · Brazil · Bulgaria · Canada · Chile · China · Czechia · France · Georgia · Germany · Hungary · India · Italy · Japan · Jordan · Kazakhstan · Malaysia · Mexico · Netherlands · New Zealand · Poland · Puerto Rico · Romania · Saudi Arabia · Singapore · South Africa · South Korea · Spain · Switzerland · Taiwan · Turkey (Türkiye) · United Kingdom · United States. Showing up to 24 locations stored in the fast local snapshot.

The Institute for Liver Health II DBA Arizona Clinical Trials

Peoria, Arizona, United States

Scottsdale Medical Specialists, Ltd

Scottsdale, Arizona, United States

Adobe Clinical Research, LLC

Tucson, Arizona, United States

Arizona Liver Health - Tucson

Tucson, Arizona, United States

Del Sol Research Management, LLC

Tucson, Arizona, United States

Hope Clinical Research

Canoga Park, California, United States

Velocity Clinical Research-Chula Vista

Chula Vista, California, United States

Southern California Research Center

Coronado, California, United States

ARK Clinical Research

Fountain Valley, California, United States

Velocity Clinical Research-Huntington Park

Huntington Park, California, United States

310 Clinical Research

Inglewood, California, United States

Velocity Clinical Research, San Diego

La Mesa, California, United States

Om Research, LLC

Lancaster, California, United States

Delta Research Partners, LLC

Los Angeles, California, United States

Catalina Research Institute, LLC

Montclair, California, United States

Clinnova Research Solutions

Orange, California, United States

Fomat Medical Research

Oxnard, California, United States

Cadena Care Institute, LLC

Poway, California, United States

Ficramed Research Institute

Poway, California, United States

Inland Empire Clinical Trials, LLC

Rialto, California, United States

Metro Clinical Trials

San Bernardino, California, United States

Acclaim Clinical Research

San Diego, California, United States

Future Innovative Treatments

Colorado Springs, Colorado, United States

South Denver Gastroenterology PC

Englewood, Colorado, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Survodutide.

Related PeptideStat pages

Put the record in context.

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