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RECRUITING
NCT07704892
PHASE3

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)

Sponsor: GlaxoSmithKline

View on ClinicalTrials.gov

Summary

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

380

Start Date

2026-07-22

Completion Date

2033-12-08

Last Updated

2026-08-05

Healthy Volunteers

No

Interventions

DRUG

Efimosfermin alfa

Efimosfermin alfa (subcutaneous injection) will be administered.

DRUG

Placebo

Placebo (subcutaneous injection) will be administered.

Locations (2)

GSK Investigational Site

Miami, Florida, United States

GSK Investigational Site

Houston, Texas, United States