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Trial · Interventional

RecruitingPhase 3Registry data

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

NCTNCT06632457 (opens ClinicalTrials.gov in a new tab)Other id1404-0064Other id2024-513741-36-00Other idU1111-1307-0227
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Recruiting
Phase
Phase 3
Enrollment
1,590 participants (estimated)
Sponsor
Boehringer Ingelheim · Industry
Design
Randomized · Double masking
Countries
30 countries

United States, 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

Start
12 Nov 2024
Primary completion
5 Jun 2029 (estimated)
Completion
5 Jun 2029 (estimated)
First posted
9 Oct 2024
Last update posted
1 Oct 2026
Conditions
Metabolic Dysfunction Associated Steatohepatitis

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2024202520262027202820292030
  1. Ph 3

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

    NCT06632457

    12 Nov 2024 to est. 5 Jun 2029

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

  • SurvodutideCombination product
  • Placebo matching survodutideCombination product

Arms2

  • Experimental

    Survodutide

  • Placebo comparator

    Placebo

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. 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.

    Registry description

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

Secondary outcomes(13)

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

    Time frame · At baseline and at Week 76.

  2. Key secondary endpoint: Percentage change from baseline in body weight

    Time frame · At baseline and at Week 76.

  3. 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.

  4. 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.

  5. Percentage change from baseline in liver stiffness in FibroScan® VCTE

    Time frame · At baseline and at Week 76.

  6. Time to first occurrence of progression to CSPH

    Time frame · up to 4.5 years.

  7. 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.

  8. Occurrence of all-cause hospitalisation (first and recurrent)

    Time frame · up to 4.5 years.

  9. 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.

  10. Absolute changes from baseline in lipids (mg/dL)

    Time frame · At baseline and at Week 76.

  11. Absolute change from baseline in aspartate aminotransferase (AST) (U/L)

    Time frame · At baseline and at Week 76.

  12. Absolute change from baseline in alanine aminotransferase (ALT) (U/L)

    Time frame · At baseline and at Week 76.

  13. Absolute change from baseline in liver stiffness (kPa) assessed by magnetic resonance elastography (MRE)

    Time frame · At baseline and at Week 76.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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