Trials / Active Not Recruiting
Active Not RecruitingNCT06161571
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)
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of 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)
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 700 (estimated)
- Sponsor
- Akero Therapeutics, Inc · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Efruxifermin | Administered by subcutaneous (SC) injection |
| DRUG | Placebo | Administered by SC injection |
Timeline
- Start date
- 2023-11-10
- Primary completion
- 2026-04-01
- Completion
- 2026-10-01
- First posted
- 2023-12-08
- Last updated
- 2025-09-12
Locations
211 sites across 13 countries: United States, Argentina, Australia, Canada, India, Israel, Mexico, Puerto Rico, South Korea, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06161571. Inclusion in this directory is not an endorsement.