Phase 3Recruiting
A Clinical Study to Investigate the Safety and Tolerability of Efimosfermin Alfa Injection in Participants With Known or Suspected F2- or F3-stage MASH (ZENITH-2)
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 3-Arm Study to Investigate the Safety and Tolerability of Efimosfermin Alfa in Participants With Known or Suspected F2- or F3-Stage Metabolic Dysfunction-Associated Steatohepatitis (MASH) (ZENITH-2)
- Sponsor
- GlaxoSmithKline (Industry)
- Enrollment
- 1,250 planned
- Conditions
- Non-alcoholic Fatty Liver Disease
- Interventions
- Efimosfermin Alfa; Placebo
- Ages
- adults, older adults
- Registry
- NCT07221188, CTIS2025-523674-16-00
Full record on ClinicalTrials.gov
From the registry
This study will evaluate the safety and tolerability of Efimosfermin Alfa for participants with known or suspected MASH with fibrosis consistent with stage F2 or F3.
Primary outcomes
- Number of participants with treatment-emergent adverse events (TEAEs) and TEAEs by severity
- Number of participants with TEAEs leading to discontinuation and TEAEs leading to discontinuation by severity
- Number of participants with Grade 3 and Grade 4 laboratory abnormalities
History
Primary completion expected
Last registry update
Started
Registered