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)
GlaxoSmithKline
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.
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participants aged between 18 and 75 years at enrolment. * Participants with history or presence of at least two components of metabolic syndrome. * Liver biopsy consistent with cirrhosis (fibrosis stage 4). Exclusion Criteria: * Participants with other chronic liver diseases. * Participants with evidence or history of decompensated liver disease or hepatocellular carcinoma. * Participants with history of Type 1 diabetes mellitus; or major Type 2 diabetes mellitus complications. * History or evidence of chronic pancreatic disease; pancreatic injury or acute pancreatitis…
Interventions
- DrugEfimosfermin alfa
Efimosfermin alfa (subcutaneous injection) will be administered.
- DrugPlacebo
Placebo (subcutaneous injection) will be administered.
Locations (2)
- GSK Investigational SiteMiami, Florida
- GSK Investigational SiteHouston, Texas