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

Conditions

• Non-alcoholic Steatohepatitis (NASH)

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Survodutide — DRUG
  Survodutide
• Placebo — DRUG
  Placebo

Study Details

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.

Key Dates

Start date

Apr 27, 2021

Status verified

Nov 2024

Primary completion

Nov 9, 2023

Completion

Dec 21, 2023

Study Design

Enrollment

295 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Survodutide 2.4 mg - planned maintenance treatment
• Experimental: Survodutide 4.8 mg - planned maintenance treatment
• Experimental: Survodutide 6.0 mg - planned maintenance treatment
• Placebo Comparator: Placebo - planned maintenance treatment

Primary Outcome Measure

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 [ Time Frame: At baseline and at 48 weeks. ]

Locations (36)

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