A Pivotal Clinical Study to Investigate the Safety and Efficacy of Efimosfermin Compared With Placebo in Adult Participants With Compensated Cirrhosis Due to Metabolic Dysfunction-associated Steatohepatitis (MASH)
Part of paid clinical trials in Miami, Florida.
- Sponsor
- GlaxoSmithKline
- Study ID
- NCT07701993
- Phase
- PHASE3
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- Efimosfermin alfa — DRUGEfimosfermin alfa (subcutaneous injection) will be administered.
- Placebo — DRUGPlacebo (subcutaneous injection) will be administered.
Study Details
This study will investigate the safety and efficacy of efimosfermin alfa in participants with compensated cirrhosis due to MASH.
Key Dates
- First listed
- Jul 14, 2026
- Start date
- Jul 22, 2026
- Status verified
- Sep 2026
- Primary completion
- Jun 23, 2033
- Completion
- Aug 24, 2033
Study Design
- Enrollment
- 1,740 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Participants receiving efimosfermin alfa
- Placebo Comparator: Participants receiving placebo
Primary Outcome Measure
Time from randomization to an adjudicated composite liver-related clinical outcome [ Time Frame: From Randomization (Day 1) to Week 356 (end of treatment) ]
Central Contacts
- US GSK Clinical Trials Call Center877-379-3718
- EU GSK Clinical Trials Call Center+44 (0) 20 89904466
Locations (5)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| GSK Investigational Site | Miami | Florida | 33135-4661 | Yaneicy Gonzalez Rojas (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | Miami | Florida | 33155 | Jorge Amaya (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | Dallas | Texas | 75243-1921 | Valentine Ebuh (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | Humble | Texas | 77346 | Brian Chou (PRINCIPAL_INVESTIGATOR) |
| GSK Investigational Site | San Antonio | Texas | 78215 | Eric Lawitz (PRINCIPAL_INVESTIGATOR) |
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