A Randomised, Double-blind, Placebo-controlled, Multicentre, Phase III Trial Evaluating Long-term Efficacy and Safety of Survodutide Weekly Injections in Adult Participants With Noncirrhotic Non-alcoholic Steatohepatitis/Metabolic Dysfunction-associated Steatohepatitis (NASH/MASH) and (F2) - (F3) Stage of Liver Fibrosis

Registration

Registration

NCT06632444

Study type

INTERVENTIONAL

Allocation

RANDOMIZED

Phase

PHASE3

Masking

DOUBLE

Status

RECRUITING

Enrollment

1800

Start

2024-10-14

Primary completion

2031-12-27

Lead sponsor

Boehringer Ingelheim

Conditions

Metabolic Dysfunction Associated Steatohepatitis (MASH); Liver Fibrosis

Interventions

COMBINATION_PRODUCT:Survodutide; COMBINATION_PRODUCT:Placebo

Results posted

FALSE

Individual participant data sharing

YES

Secondary identifiers

REGISTRY:2024-513739-25-00; REGISTRY:U1111-1306-9071

Registered primary outcomes

• Part 1: Resolution of MASH without worsening of liver fibrosis on MASH Clinical Research Network (CRN) fibrosis score [Baseline and at Week 52.]
• Part 1: At least a 1-point improvement in fibrosis stage with no worsening of MASH [Baseline and at Week 52.]
• Part 2: Time to first occurrence of any of components of the composite endpoint consisting of progression to cirrhosis, all-cause mortality, liver transplant, hepatic decompensation event(s), worsening of MELD score to ≥15, progression to CSPH [Up to 7 years.]