Testing Survodutide against a placebo for metabolic dysfunction associated steatohepatitis (MASH)
Official title: LIVERAGE™: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Moderate or Advanced Liver Fibrosis
A Randomised, Double-blind, Placebo-controlled, Multicentre, Phase III Trial Evaluating Long-term Efficacy and Safety of Survodutide Weekly Injections in Adult Participants With Noncirrhotic Non-alcoholic Steatohepatitis/Metabolic Dysfunction-associated Steatohepatitis (NASH/MASH) and (F2) - (F3) Stage of Liver Fibrosis
- Phase 3
- 2 groups
- Sites in Québec, Calgary and 5 more cities
- Recruiting
Interventions
- Other intervention
Survodutide
Subcutaneous injection, prefilled syringe
- Other intervention
Placebo
Subcutaneous injection, prefilled syringe
Canadian Sites (9)
7 of 9 recruiting
- Recruiting
University of Calgary
Calgary, Alberta
- Recruiting
University of British Columbia
Vancouver, British Columbia
- Recruiting
Pacific Gastroenterology Associates
Vancouver, British Columbia
- Recruiting
Viable Clinical Research
Bridgewater, Nova Scotia
- Recruiting
Toronto Liver Centre
Toronto, Ontario
- Recruiting
Diex Recherche Québec
Québec
- Recruiting
Centre de Médecine Métabolique de Lanaudière
Terrebonne, Quebec
- Not yet recruiting
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec
- Not yet recruiting
McGill University Health Centre (MUHC)
Montreal, Quebec
Eligibility Criteria
See who this study is looking for19 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Male or female participants ≥18 years (or who are of legal age in countries where that is greater than 18 years) of age at time of consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
- +Diagnosis of MASH (non-alcoholic fatty liver disease (NAFLD)) activity score \[NAS\] ≥4
- +Stable body weight defined as less than 5% self-reported change in body weight 3 months prior to the screeningScreeningThe checks done before joining, to see whether a study fits.Read more → or during the period between the historical biopsy and randomisationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →, if a historical biopsy is used
- +Be willing to maintain a stable diet and physical activity levels throughout the entire trial Further inclusion criteriaInclusion criteriaThe things you must have or be for a study to consider you.Read more → apply
Exclusion
- −Any of the following liver laboratory test abnormalities at screeningScreeningThe checks done before joining, to see whether a study fits.Read more →:
- −Serum AST and/or alanine aminotransferase (ALT) elevation ≥5x upper limit of normal (ULN)
- −Platelet count \<140 000/mm\^3 (\<140 GI/L)
- −Alkaline phosphatase \>2x upper limit of normal (ULN)
- −Abnormal synthetic liver function as defined by screening central laboratory evaluation:
- −Albumin below \<3.5 g/dL (35.0 g/L)
- −OR International normalised ratio (INR) of prothrombin time \>1.3
- −OR total serum bilirubin concentration ≥1.5x ULN
- −Any history or evidence of acute or chronic liver disease other than MASH
- −Histologically documented liver cirrhosis (fibrosis stage F4), either at screening or in a historical biopsy
- −History of or current diagnosis of hepatocellular carcinoma
- −History of or planned liver transplant
- −Inability or unwillingness to undergo a liver biopsy at screening (if a suitable historical biopsy is unavailable for central review), or during trial conduct.
- −History of portal hypertension or presence of decompensated liver disease
- −Model for end-stage liver disease (MELD) score ≥12 due to liver disease. Further exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → apply
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives Survodutide.
Registry label: A: Survodutide
Group B, the placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group, receives Placebo.
Registry label: B: Placebo
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
Neither you nor the study team would know which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 1,800 people.
The study is currently expected to finish around December 2031.
The main measurement is taken over: BaselineBaselineYour starting measurements, taken before treatment begins.Read more → and at Week 52.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Part 1: Resolution of MASH without worsening of liver fibrosis on MASH Clinical Research Network (CRN) fibrosis score — measured over BaselineBaselineYour starting measurements, taken before treatment begins.Read more → and at Week 52.
Part 1: At least a 1-point improvement in fibrosis stage with no worsening of MASH — measured over Baseline and at Week 52.
Part 2: Time to first occurrence of any of components of the composite endpointEndpointThe specific thing a study measures to answer its question.Read more → consisting of progression to cirrhosis, all-cause mortality, liver transplant, hepatic decompensation event(s), worsening of MELD score to ≥15, progression to CSPH — measured over Up to 7 years.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06632444 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About SurvodutideCombination product
Subcutaneous injection, prefilled syringe
From the trial registry — its own words, unedited.
What a combination product is here: A product that combines two categories — for example a drug delivered by a device.
Read the full explanation → · in clinical review
About PlaceboCombination product
Subcutaneous injection, prefilled syringe
From the trial registry — its own words, unedited.
What a combination product is here: A product that combines two categories — for example a drug delivered by a device.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
Neither you nor the study team would know which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: BaselineBaselineYour starting measurements, taken before treatment begins.Read more → and at Week 52..
The study as a whole is currently expected to finish around 2031-12-27.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 1,800 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 16 locations, including: Québec, Canada; Calgary, Alberta, Canada; Vancouver, British Columbia, Canada; Bridgewater, Nova Scotia, Canada; Toronto, Ontario, Canada; Montreal, Quebec, Canada, and 10 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
This study is open to adults who are at least 18 years old living with obesity and have: * a confirmed liver disease called non-alcoholic steatohepatitis (NASH)/metabolic associated steatohepatitis (MASH) and * moderate or advanced liver fibrosis People with a history of acute or chronic liver diseases other than MASH or chronic 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 MASH and moderate or advanced liver fibrosis improve their liver function. This study has 2 parts. The purpose of the first part of this study is to find out the effect of survodutide on MASH and liver fibrosis. The purpose of the second part is to find out how safe and effective survodutide is in improving 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. The survodutide doses are slowly increased until the target dose is reached. All participants receive counselling to make changes to their diet and to exercise regularly. Participants are in the study for up to 7 years. During this time, they regularly visit the study site or have remote visits by video call. For about the first year of the study, participants have these visits every 2 weeks, increasing to every 4 weeks and then every 6 weeks. After being in the study for a little over a year participants will then alternate between visiting the study site or having 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 and effects on the stomach and intestines are regularly measured. At some visits the liver is measured using different imaging methods. At 2 or 3 visits doctors take a small sample of liver tissue (biopsy). The participants also fill in questionnaires about their symptoms and quality of life. The results are compared between the groups to see whether the treatment works.
Other Sites (9)
Clinical Research Institute of Michigan, LLC
Clinton Township, Michigan, United States
West Michigan Clinical Research Center
Wyoming, Michigan, United States
MNGI Digestive Health, PA
Minneapolis, Minnesota, United States
NewYork-Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, United States
Basil Clinical
Laurelton, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Velocity Clinical Research, Seattle
Seattle, Washington, United States
Velocity Clinical Research-Spokane-69716
Spokane, Washington, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.