Phase 3Recruiting
A Study to Investigate Safety and Efficacy of Efimosfermin Compared With Placebo in Adult Participants With Compensated Cirrhosis Due to Metabolic Dysfunction-associated Steatohepatitis (MASH) (NEBULA-2)
A Phase 3, Two-part, Double-blind, Randomized, Placebo-controlled Study to Investigate the Safety and Efficacy of Efimosfermin Alfa Injection in Adult Participants With Compensated Cirrhosis (Stage F4 Fibrosis) Due to Metabolic Dysfunction-associated Steatohepatitis (NEBULA-2)
- Sponsor
- GlaxoSmithKline (Industry)
- Enrollment
- 380 planned
- Conditions
- Metabolic Dysfunction-associated Steatohepatitis
- Interventions
- Efimosfermin alfa; Placebo
- Ages
- adults, older adults
- Registry
- NCT07704892, CTIS2026-525757-37-00
Full record on ClinicalTrials.gov
From the registry
This is a multi-center, randomized, two-part (Part A and Part B) study investigating the safety and efficacy of efimosfermin alfa in adult participants with compensated cirrhosis due to MASH. Participants who complete the treatment during Part A of the study and meet the inclusion criteria will have the option to enroll in Part B (open label) of the study.
Primary outcomes
- Part A: Proportion of participants achieving improvement in liver fibrosis by >=1 stage and no worsening of MASH
History
Study completion expected
Primary completion expected
Last registry update
Started
Registered