This is a registry record, not a result. A trial being listed, recruiting or completed says nothing by itself about whether the compound works or is safe.
| Registry number | NCT04771273 |
|---|---|
| Status | Completed |
| Phase | Phase 2 |
| Sponsor | Boehringer Ingelheim |
| Enrollment | 295 participants |
| Design | Interventional, Randomized, Parallel, Masking: Quadruple |
| Conditions | Non-alcoholic Steatohepatitis (NASH) |
| Interventions | Survodutide; Placebo |
| Start | Apr 27, 2021 |
| Primary completion | Nov 9, 2023 |
| Study completion | Dec 21, 2023 |
| Results posted | Yes, in the registry |
| Registry last updated | Dec 3, 2024 |
Compounds on this site that cite this trial
What the registry says the trial is about
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.
Primary outcomes
These are what the trial was designed to measure first. They are registered in advance, which is what makes a later result checkable.
| Outcome measure | Time frame |
|---|---|
| Improvement (Yes/ no) From Baseline in Liver Histological Findings Based on Liver Biopsy After 48 Weeks of Treatment in Patients With NASH (NAS u2265 4, Fibrosis F1-F3) - Actual Maintenance Treatment | At baseline and at 48 weeks. |
| Improvement (Yes/ no) From Baseline in Liver Histological Findings Based on Liver Biopsy After 48 Weeks of Treatment in Patients With NASH (NAS u2265 4, Fibrosis F1-F3) - Planned Maintenance Treatment | At baseline and after 48 weeks of treatment. |
10 secondary outcomes also registered. See the registry record for the full list.
Source: ClinicalTrials.gov (U.S. National Library of Medicine). Last checked against the registry on Oct 3, 2026. See the trial changes feed for what has changed recently.
