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NCT06215716 · ClinicalTrials.gov record · last posted 2026-08-07

A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis

Name: A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis — clinical trial record (NCT06215716)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

StatusRecruiting

PhasePhase 3

SponsorAkero Therapeutics, Inc

Started2023-12-01

View on ClinicalTrials.gov ↗

from the ClinicalTrials.gov record

This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in subjects with non-cirrhotic NASH/MASH and fibrosis stage 2 or 3 (F2 or F3). The study will enroll subjects in two cohorts for a total samples size of 1650 subjects.

Protocol amendment history 3 changes detected by DataLookout

2026-06-26

Primary completion pushed: 2032-11 → 2033-02

2026-06-26

Completion pushed: 2032-11 → 2033-02

2026-06-04

Trial sites expanded: 349 → 355 locations

Trial Details

NCT Number	NCT06215716
Lead Sponsor	Akero Therapeutics, Inc
Conditions	NASH With Fibrosis, MASH With Fibrosis
Enrollment	1,650 participants
Start Date	2023-12-01
Primary Completion	2033-02 (estimated)
Study Completion	2033-02 (estimated)
Updated on ClinicalTrials.gov	2026-08-07