A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 3-Arm Study to Investigate the Safety and Tolerability of Efimosfermin Alfa in Participants With Known or Suspected F2- or F3-Stage Metabolic Dysfunction-Associated Steatohepatitis (MASH) (ZENITH-2)
GlaxoSmithKline
Summary
This study will evaluate the safety and tolerability of Efimosfermin Alfa for participants with known or suspected MASH with fibrosis consistent with stage F2 or F3.
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Able and willing to understand and sign a written informed consent form (ICF) that must be obtained prior to the initiation of study procedures * Age \>=18 through \<=75 years at enrolment * History or presence of 2 or more of the 5 components of metabolic syndrome per American Heart Association definition * History or presence of known or suspected MASH with evidence of fibrosis Exclusion Criteria: * ALT or AST \>=5 × upper limit of normal (ULN) * Total bilirubin (BILI) \>=1.3 milligram per deciliter (mg/dL). Individuals with documented Gilbert's syndrome may be enrol…
Interventions
- DrugEfimosfermin Alfa
Efimosfermin Alfa will be administered
- DrugPlacebo
Placebo will be administered
Locations (43)
- GSK Investigational SiteArcadia, California
- GSK Investigational SiteCovina, California
- GSK Investigational SiteLos Angeles, California
- GSK Investigational SiteSanta Maria, California
- GSK Investigational SiteCape Coral, Florida
- GSK Investigational SiteDoral, Florida