← Back to Search

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

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

Compensated metabolic dysfunction-associated steatohepatitis (MASH) cirrhosis diagnosed according to modified Liver Forum criteria (Noureddin et al, Gastroenterology 2020;159:422-427)

Must not have

History of transjugular intrahepatic portosystemic shunt (TIPS) or other radiological/surgical procedure for portal hypertension treatment

Model of end-stage liver Disease (MELD) score >12 due to liver disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4.5 years.

Awards & highlights

Pivotal Trial

Summary

"This trial is for adults with a liver disease called NASH or MASH and a high BMI. The study aims to see if a medicine called survodutide can help improve liver function. Participants

Who is the study for?

Adults over 18 with NASH or MASH cirrhosis, a BMI of at least 27 kg/m2 (25 kg/m2 for Asians), and certain liver fat measurements can join this trial. Those with other chronic liver diseases or high alcohol intake are excluded.

What is being tested?

The study tests if survodutide improves liver function in people with NASH/MASH cirrhosis. Participants are randomly assigned to receive either survodutide or placebo weekly, while also getting diet and exercise counseling.

What are the potential side effects?

While the specific side effects of survodutide aren't listed here, participants' health is monitored for any unwanted effects throughout the study.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am an adult over 18 or the legal age of consent in my country.

Select...

I have a specific type of liver cirrhosis related to fatty liver disease.

Exclusion Criteria

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

Select...

I have had a procedure to treat high blood pressure in the liver.

Select...

My liver disease severity score is above 12.

Select...

I have had a liver transplant or am on the waiting list for one.

Select...

I have tested positive for Hepatitis C.

Select...

I have liver disease due to alcohol or drug use.

Select...

I have had liver problems, like bleeding in my stomach, fluid buildup, or confusion due to liver disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4.5 years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4.5 years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4.5 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

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