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A Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) Due to MASH

RECRUITINGPhase 2Sponsored by GlaxoSmithKline
Actively Recruiting
PhasePhase 2
SponsorGlaxoSmithKline
Started2025-04-09
Est. completion2028-07-10
Eligibility
Age18 Years – 75 Years
Healthy vol.Accepted
Locations30 sites
View on ClinicalTrials.gov →

NCT06920043

Summary

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.

Eligibility

Age: 18 Years – 75 YearsHealthy volunteers accepted
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.

Conditions3

Liver DiseaseMetabolic Dysfunction-Associated SteatohepatitisNon Alcoholic Fatty Liver Disease

Interventions1

Efimosfermin

Locations30 sites

GSK Investigational Site
Chandler, Arizona, 85224
US GSK Clinical Trials Call Center877-379-3718GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Mesa, Arizona, 85381
US GSK Clinical Trials Call Center877-379-3718GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Tucson, Arizona, 85712
US GSK Clinical Trials Call Center877-379-3718GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Fresno, California, 93720
US GSK Clinical Trials Call Center877-379-3718GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Lancaster, California, 93534
US GSK Clinical Trials Call Center877-379-3718GSKClinicalSupportHD@gsk.com

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