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NCT06161571 · ClinicalTrials.gov record · last posted 2026-04-30

A Study Evaluating Efruxifermin in Subjects With Non-invasively Diagnosed Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Nonalcoholic Fatty Liver Disease (NAFLD)/Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)

StatusActive, Not Recruiting
PhasePhase 3
Started2023-11-10
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from the ClinicalTrials.gov record
The aim of this study is to assess the safety and tolerability of EFX compared to placebo in subjects with non-invasively diagnosed NASH/MASH and NAFLD/MASLD.

Amendment record 16 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 16 times since 2023-11-29; most recent amendment 2026-04-28. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2025-06-03
Status change Enrolling by Invitation→Active, Not Recruitingv14
2025-01-31
Status change Recruiting→Enrolling by Invitationv13
Trial Details
NCT Number NCT06161571
Lead Sponsor Akero Therapeutics, Inc
Conditions NASH/MASH, NAFLD/MASLD
Enrollment 700 participants
Start Date 2023-11-10
Primary Completion 2026-03-03 (estimated)
Study Completion 2026-06-19 (estimated)
Updated on ClinicalTrials.gov 2026-04-30