Study S002626

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)

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

Registration

Registration: NCT05039450
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE2
Masking: QUADRUPLE
Status: COMPLETED
Enrollment: 213
Start: 2021-07-30
Primary completion: 2023-12-15
Lead sponsor: Akero Therapeutics, Inc
Conditions: NASH - Nonalcoholic Steatohepatitis
Interventions: DRUG:EFX; DRUG:Placebo
Results posted: TRUE
Individual participant data sharing: NO

Registered primary outcomes

Main: Change From Baseline in Fibrosis With no Worsening Steatohepatitis Assessed by NASH CRN System [Week 36]

Linked records (2)

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
R0050940	Consistent efficacy of efruxifermin across PNPLA3 genotypes in phase 2b trials in MASH Naga Chalasani, Hepatology	2026	Randomized trial	PMID 42127430 DOI	cites ClinicalTrials.gov:NCT05039450
R0004489	Safety and Efficacy of Efruxifermin in Combination With a GLP-1 Receptor Agonist in Patients With NASH/MASH and Type 2 Diabetes in a Randomized Phase 2 Study. Harrison SA, Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association	2025	Randomized trial	PMID 38447814 DOI	cites ClinicalTrials.gov:NCT05039450; registry reference DERIVED:38447814