A Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) Due to MASH
Purpose
The purpose of this study is to evaluate the safety, tolerability, preliminary efficacy, and pharmacokinetics (PK) of efimosfermin in participants with metabolic dysfunction associated steatohepatitis (MASH) and compensated cirrhosis consistent with stage F4 fibrosis.
Conditions
- Metabolic Dysfunction-Associated Steatohepatitis
- Non-alcoholic Fatty Liver Disease
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Ability to understand and sign a written informed consent form (ICF) - Age 18 through 75 years at enrollment - History or presence of 2 or more of the 5 components of metabolic syndrome - Liver biopsy confirmation of MASH consistent with stage F4 fibrosis - Other inclusion criteria may apply.
Exclusion Criteria
- Individuals with chronic liver disease from other causes, or any history or evidence of decompensated liver disease - History of type 1 diabetes - Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥5 × the upper limit of normal (ULN) - Other exclusion criteria may apply.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Efimosfermin (Dose 1) |
Participants will receive efimosfermin (Dose 1) once every 4 weeks (Q4W). |
|
|
Experimental Efimosfermin (Dose 2) |
Participants will receive efimosfermin (Dose 2) Q4W. |
|
|
Placebo Comparator Placebo |
Participants will receive placebo Q4W. |
|
Recruiting Locations
GSK Investigational Site
Chandler, Arizona 85224
Chandler, Arizona 85224
GSK Investigational Site
Mesa, Arizona 85381
Mesa, Arizona 85381
GSK Investigational Site
Tucson, Arizona 85712
Tucson, Arizona 85712
GSK Investigational Site
Fresno, California 93720
Fresno, California 93720
GSK Investigational Site
Lancaster, California 93534
Lancaster, California 93534
GSK Investigational Site
Pasadena, California 91105
Pasadena, California 91105
GSK Investigational Site
Rialto, California 92377
Rialto, California 92377
GSK Investigational Site
Santa Maria, California 93458
Santa Maria, California 93458
GSK Investigational Site
Miami, Florida 33156
Miami, Florida 33156
GSK Investigational Site
Viera, Florida 32940
Viera, Florida 32940
GSK Investigational Site
Marietta, Georgia 30060
Marietta, Georgia 30060
GSK Investigational Site
Baltimore, Maryland 21202
Baltimore, Maryland 21202
GSK Investigational Site
Kansas City, Missouri 64131
Kansas City, Missouri 64131
GSK Investigational Site
New York, New York 10029
New York, New York 10029
GSK Investigational Site
Fayetteville, North Carolina 28304
Fayetteville, North Carolina 28304
GSK Investigational Site
Wilson, North Carolina 27612
Wilson, North Carolina 27612
GSK Investigational Site
Austin, Texas 78745
Austin, Texas 78745
GSK Investigational Site
Austin, Texas 78757
Austin, Texas 78757
GSK Investigational Site
Austin, Texas 78757
Austin, Texas 78757
GSK Investigational Site
Dallas, Texas 75203
Dallas, Texas 75203
GSK Investigational Site
Georgetown, Texas 78626
Georgetown, Texas 78626
GSK Investigational Site
Houston, Texas 77030
Houston, Texas 77030
GSK Investigational Site
Houston, Texas 77030
Houston, Texas 77030
GSK Investigational Site
Houston, Texas 77079
Houston, Texas 77079
GSK Investigational Site
Pasadena, Texas 77505
Pasadena, Texas 77505
GSK Investigational Site
Pearland, Texas 77584
Pearland, Texas 77584
GSK Investigational Site
San Antonio, Texas 78215
San Antonio, Texas 78215
GSK Investigational Site
San Antonio, Texas 78229
San Antonio, Texas 78229
GSK Investigational Site
Waco, Texas 76710
Waco, Texas 76710
GSK Investigational Site
Richmond, Virginia 23249
Richmond, Virginia 23249
More Details
- Status
- Recruiting
- Sponsor
- GlaxoSmithKline