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NCT06161571Phase 3ACTIVE NOT RECRUITING

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)

Study Summary

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.

Conditions
NASH/MASHNAFLD/MASLD
Interventions / Drugs
EfruxiferminPlacebo
View on ClinicalTrials.gov ↗
Sponsor
AKRO
Akero Therapeutics
Metabolic Disease
D38/100
Study Details
Enrollment700 participants
Primary Completion—
Lead SponsorAkero Therapeutics, Inc
Data Retrieved2026-04-11 02:53:02.345439+00:00
What This Trial Means for Biotech Investors
Trial Phase Context

Phase 3 trials are pivotal studies with large patient populations (hundreds to thousands) designed to prove efficacy and safety for FDA submission. A successful Phase 3 readout is typically the last major hurdle before a New Drug Application (NDA) or BLA filing.

Status & Expected Data

Enrollment is complete. The trial is in its follow-up or data collection phase — a readout may occur on or near the primary completion date.

Enrolled: 700 participants
Sponsor Catalyst Profile

Akero Therapeutics (AKRO) is the sponsoring company for this trial. BiotechSign currently grades this company D (38/100) based on composite catalyst signals across its full pipeline. This trial is one data point in that overall catalyst picture.

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