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)
Purpose
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.
Condition
- Metabolic Dysfunction-associated Steatohepatitis
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Sex
- All
- Accepts 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 within 6 months before Screening. - A recent history or planned surgical procedures or medications intended to produce significant weight loss. - Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) >= 5 times upper limit normal (ULN). - Current or history of excessive alcohol intake
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
- Masking Description
- The Part A of study is a double-blind study
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Part A: Participants receiving Efimosfermin alfa |
Participants will receive efimosfermin alfa in Part A of the study. |
|
|
Placebo Comparator Part A: Participants receiving Placebo |
Participants will receive placebo in Part A of the study. |
|
|
Experimental Part B: Participants receiving Efimosfermin alfa |
All participants will receive efimosfermin alfa in Part B of the study. |
|
Recruiting Locations
GSK Investigational Site
Miami, Florida 33135
Miami, Florida 33135
GSK Investigational Site
Houston, Texas 77058
Houston, Texas 77058
More Details
- Status
- Recruiting
- Sponsor
- GlaxoSmithKline