Study S000288

A Phase III Double-blind, Randomised, Placebo-controlled Trial to Evaluate Liver-related Clinical Outcomes and Safety of Once Weekly Injected Survodutide in Participants With Compensated Non-alcoholic Steatohepatitis/Metabolic Dysfunction Associated Steatohepatitis (NASH/MASH) Cirrhosis

ClinicalTrials.gov record

Registration

Registration: NCT06632457
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: DOUBLE
Status: RECRUITING
Enrollment: 1590
Start: 2024-11-12
Primary completion: 2029-06-05
Lead sponsor: Boehringer Ingelheim
Conditions: Metabolic Dysfunction Associated Steatohepatitis
Interventions: COMBINATION_PRODUCT:Survodutide; COMBINATION_PRODUCT:Placebo matching survodutide
Results posted: FALSE
Individual participant data sharing: YES
Secondary identifiers: REGISTRY:2024-513741-36-00; REGISTRY:U1111-1307-0227

Registered primary outcomes

Time to first occurrence of any component of the composite clinical endpoint (at EoS) consisting of: all-cause mortality, liver transplant, hepatic decompensation events, worsening of MELD score to ≥15 and progression to CSPH [up to 4.5 years.]

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