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)

Conditions

• Metabolic Dysfunction-associated Steatohepatitis

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Efimosfermin alfa — DRUG
  Efimosfermin alfa (subcutaneous injection) will be administered.
• Placebo — DRUG
  Placebo (subcutaneous injection) will be administered.

Study Details

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.

Key Dates

First listed

Jul 15, 2026

Start date

Jul 22, 2026

Status verified

Sep 2026

Primary completion

Oct 16, 2030

Completion

Dec 8, 2033

Study Design

Enrollment

380 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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.

Primary Outcome Measure

Part A: Proportion of participants achieving improvement in liver fibrosis by >=1 stage and no worsening of MASH [ Time Frame: At Week 96 ]

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 (10)

Find similar trials in Little Rock, AR

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