Phase 3Recruiting
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) (NEBULA-1)
A Phase 3, Double-blind, Randomized, Placebo Controlled, 2-arm Study to Investigate the Safety and Efficacy of Efimosfermin Alfa Injection in Adult Participants With Compensated Cirrhosis Due to Metabolic Dysfunction-associated Steatohepatitis (NEBULA-1)
- Sponsor
- GlaxoSmithKline (Industry)
- Enrollment
- 1,740 planned
- Conditions
- Metabolic Dysfunction-associated Steatohepatitis
- Interventions
- Efimosfermin alfa; Placebo
- Ages
- adults, older adults
- Registry
- NCT07701993, CTIS2026-525755-82-00
Full record on ClinicalTrials.gov
From the registry
This study will investigate the safety and efficacy of efimosfermin alfa in participants with compensated cirrhosis due to MASH.
Primary outcomes
- Time from randomization to an adjudicated composite liver-related clinical outcome
History
Study completion expected
Primary completion expected
Last registry update
Started
Registered