A Study to Test Safety and Efficacy of Survodutide (BI456906) in Adults With Non-alcoholic Steatohepatitis (NASH) and Fibrosis (F1-F3)

NCT04771273 · Completed

Last updated 2026-05-28

This clinical trial is testing the safety and effectiveness of the drug survodutide (BI456906) in adults with non-alcoholic steatohepatitis (NASH) and mild to moderate liver scarring (fibrosis stages F1-F3).

Status Completed The study has finished.

Phase Phase 2 Tests whether it works and watches safety in a moderate group.

Type Interventional (clinical trial)

Design Randomized, quadruple-blind treatment study

Participants 295 people

Who can join Ages 18–80 · all sexes

Timeline Started 2021-04 · est. completion 2023-12

Where 154 sites · Australia, Austria, Belgium, Canada, China, Czechia, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Japan, Malaysia, Netherlands, New Zealand, Poland, Portugal, Singapore, South Korea, Spain, Taiwan, United Kingdom, United States

What this study is testing ClinicalTrials.gov NCT04771273 ↗

Description as written by the study sponsor.

This study is open for men and women with a liver disease called nonalcoholic steatohepatitis (NASH) and liver fibrosis. The purpose of the study is to find out whether a medicine called BI 456906 helps patients with NASH and liver fibrosis. The study tests 3 different doses of BI 456906 to find the dose that helps best. Participants are put into 4 groups randomly, which means by chance. There are 3 groups that each receive a different dose of BI 456906 and there is 1 group that receives placebo. BI 456906 and placebo are given as an injection under the skin once per week. The placebo injection looks like the BI 456906 injection but does not contain any medicine. Participants are in the study for a little over 1 year (60 weeks). During this time, they visit the study site several times and have some video calls in addition. At the visits, the study doctors take different measurements. To see whether the treatment works, the doctors take a very small sample of liver tissue (biopsy) from each participant at the start and at the end of the study. They also examine the liver by ultrasound and MRI. The doctors also regularly check the general health of the participants.

Treatments tested

Survodutide also known as BI 456906 Drug

Survodutide
Placebo Drug

Placebo

Main thing measured	Improvement (Yes/ no) From Baseline in Liver Histological Findings Based on Liver Biopsy After 48 Weeks of Treatment in Patients With NASH (NAS ≥ 4, Fibrosis F1-F3) - Actual Maintenance Treatment
Sponsor	Boehringer Ingelheim
Conditions studied	Non-alcoholic Steatohepatitis (NASH)
GLP-1 drugs	survodutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT04771273 ↗