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Peptide

Survodutide for Fatty Liver Disease

Phase 3

Recruiting

Research Sponsored by Boehringer Ingelheim

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of MASH (non-alcoholic fatty liver disease (NAFLD) activity score [NAS] ≥4, with at least 1 point in inflammation and ballooning each) and fibrosis stage F2-F3 proven by a biopsy conducted during the screening period or by a historical biopsy conducted within the last 6 months prior to randomisation

Be older than 18 years old

Must not have

History of or planned liver transplant

History of portal hypertension or presence of decompensated liver disease (including hepatic encephalopathy, variceal bleeding, ascites, and spontaneous bacterial peritonitis)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 7 years.

Awards & highlights

Pivotal Trial

Summary

"This trial is for adults with a liver disease called non-alcoholic steatohepatitis (NASH) or metabolic-associated steatohepatitis (MASH) and moderate or advanced liver fib

Who is the study for?

Adults over 18 with MASH (a type of non-alcoholic fatty liver disease) and moderate to advanced fibrosis confirmed by a biopsy can join. They must not have other chronic liver diseases or a history of heavy alcohol use, maintain stable body weight, and keep consistent diet and exercise during the trial.

What is being tested?

The LIVERAGE™ study is testing if Survodutide improves liver function in MASH patients with fibrosis. Participants are randomly assigned to receive either Survodutide or placebo via weekly injections, with double the chance of receiving Survodutide. The study spans up to 7 years with regular health checks.

What are the potential side effects?

While specific side effects aren't listed here, participants' health is closely monitored for any unwanted effects. This includes tracking changes in body weight and gastrointestinal symptoms as well as using imaging methods and occasional liver biopsies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with MASH, with a NAS score of 4 or more, and moderate liver fibrosis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had or am planning to have a liver transplant.

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I have a history of serious liver problems.

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I cannot or do not want to have a liver biopsy.

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I have liver disease, but it's not MASH.

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My liver has been diagnosed with severe scarring.

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My liver disease severity score is 12 or higher.

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I have or had liver cancer.

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I have had pancreatitis or my enzyme levels are high.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 7 years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 7 years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 7 years. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Part 2: Time to first occurrence of any of components of the composite endpoint consisting of progression to cirrhosis, all-cause mortality, liver transplant, hepatic decompensation event(s), worsening of MELD score to ≥15, progression to CSPH

Secondary study objectives

Key secondary endpoint part 1: Absolute change from baseline in glycosylated haemoglobin (HbA1c)

Key secondary endpoint part 2: Absolute change from baseline in HbA1c

Part 1: Absolute change from baseline in LFC in MRI-PDFF

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