Study S001877

Multicenter, Double-blind, Parallel-group, Randomized, 48 Weeks, Dose-ranging, Placebo-controlled Phase II Trial to Evaluate Efficacy, Safety and Tolerability of Multiple Subcutaneous (s.c.) Doses of BI 456906 in Patients With Non-alcoholic Steatohepatitis (NASH) and Fibrosis.

ClinicalTrials.gov record Study Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration: NCT04771273
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE2
Masking: QUADRUPLE
Status: COMPLETED
Enrollment: 295
Start: 2021-04-27
Primary completion: 2023-11-09
Lead sponsor: Boehringer Ingelheim
Conditions: Non-alcoholic Steatohepatitis (NASH)
Interventions: DRUG:Survodutide; DRUG:Placebo
Results posted: TRUE
Individual participant data sharing: YES
Secondary identifiers: EUDRACT_NUMBER:2020-002723-11

Registered primary outcomes

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 [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 ≥ 4, Fibrosis F1-F3) - Planned Maintenance Treatment [At baseline and after 48 weeks of treatment.]

Linked records (3)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

Record	Title	Year	Design	Identifiers	Link basis
R0011519	Weight reduction-dependent/-independent effects of survodutide on liver endpoints: Mediation analysis of a phase 2 trial in MASH. Noureddin M, Hepatology (Baltimore, Md.)	2026	Other trial	PMID 42545725 DOI	cites ClinicalTrials.gov:NCT04771273
R0015897	A Phase 2 Randomized Trial of Survodutide in MASH and Fibrosis. Sanyal AJ, The New England journal of medicine	2024	Randomized trial	PMID 38847460 DOI	cites ClinicalTrials.gov:NCT04771273; cites EudraCT:2020-002723-11; registry reference DERIVED:38847460
R0040528	From cause to consequence: Insights into incident diabetes mellitus after hepatic steatosis Manik Aggarwal, Clinical Liver Disease	2023	Other	PMID 36938314 DOI	cites ClinicalTrials.gov:NCT04771273