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

What Was Tested

This registered phase 2 trial tested Survodutide.

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.

It had four arms (groups): one (experimental), one (experimental), one (experimental) and Placebo - planned maintenance treatment (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

295 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Patients willing and able to undergo liver biopsies per protocol as judged by the Investigator. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.

The full record lists 6 inclusion and 7 exclusion criteria; among the exclusions: personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2, manifest hypo- or hyperthyroidism at visit 1.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

The participants were allocated by chance, so the Survodutide group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Survodutide.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2021-04-27 with completion listed for 2023-11-09.

It ran at 154 sites in United States (36), Japan (21), China (13), Poland (11), Germany (9) and Italy (6).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 10 secondary outcomes, for example Absolute Change of Liver Fat Content From Baseline After 48 Weeks of Treatment Assessed by MRI-PDFF - Actual Maintenance Treatment, Absolute Change of Liver Fat Content From Baseline After 48 Weeks of Treatment Assessed by MRI-PDFF - Planned Maintenance Treatment, Percent Change of Liver Fat Content From Baseline After 48 Weeks of Treatment Assessed by MRI-PDFF - Actual Maintenance Treatment, Percent Change of Liver Fat Content From Baseline After 48 Weeks of Treatment Assessed by MRI-PDFF - Planned Maintenance Treatment, Absolute Change From Baseline in NAS After 48 Weeks of Treatment Assessed by Liver Biopsy - Actual Maintenance Treatment and Absolute Change From Baseline in NAS After 48 Weeks of Treatment Assessed by Liver Biopsy - Planned Maintenance Treatment.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Survodutide in 295 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Survodutide compound page, all human trials.