Trials / Recruiting
RecruitingNCT07221227
A Pivotal Clinical Study to Investigate Efimosfermin Alfa in Participants With Biopsy-confirmed F2- or F3-stage MASH
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 3-Arm Study to Investigate the Safety and Efficacy of Efimosfermin Alfa in Participants With Biopsy-Confirmed F2- or F3-Stage Metabolic Dysfunction-Associated Steatohepatitis (MASH) (ZENITH-1)
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,200 (estimated)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to assess the safety and efficacy of efimosfermin alfa in the resolution of steatohepatitis and improvement of liver-related clinical outcome compared to placebo in individuals with MASH and biopsy-confirmed F2- or F3-stage fibrosis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Efimosfermin alfa | Efimosfermin alfa will be administered |
| DRUG | Efimosfermin alfa | Efimosfermin alfa will be administered |
| DRUG | Placebo | Placebo will be administered |
Timeline
- Start date
- 2025-10-24
- Primary completion
- 2028-03-29
- Completion
- 2031-12-12
- First posted
- 2025-10-27
- Last updated
- 2026-04-16
Locations
49 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07221227. Inclusion in this directory is not an endorsement.