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

Conditions

• Metabolic Dysfunction-Associated Steatohepatitis
• Non-alcoholic Fatty Liver Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Efimosfermin — DRUG
  Efimosfermin will be administered as a subcutaneous injection.
• Placebo — DRUG
  Placebo will be administered as a subcutaneous injection.

Study Details

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.

Key Dates

First listed

Apr 9, 2025

Start date

Apr 9, 2025

Status verified

Jul 2026

Primary completion

Jul 10, 2028

Completion

Jul 10, 2028

Study Design

Enrollment

42 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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.

Primary Outcome Measure

Number of participants with treatment emergent adverse events (TEAEs) [ Time Frame: From Day 1 to 100 weeks ]

Central Contacts

• US GSK Clinical Trials Call Center
  877-379-3718
  [email protected]
• EU GSK Clinical Trials Call Center
  +44 (0) 20 89904466
  [email protected]

Locations (30)

Find similar trials in Chandler, AZ

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