A Pivotal Clinical Study to Investigate Efimosfermin Alfa in Participants With Biopsy-confirmed F2- or F3-stage MASH

Conditions

• Non-alcoholic Fatty Liver Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Efimosfermin alfa — DRUG
  Efimosfermin alfa will be administered
• Efimosfermin alfa — DRUG
  Efimosfermin alfa will be administered
• Placebo — DRUG
  Placebo will be administered

Study Details

The purpose of this study is to assess the safety and efficacy of efimosfermin alfa in the resolution of steatohepatitis and improvement of liver-related clinical outcome compared to placebo in individuals with MASH and biopsy-confirmed F2- or F3-stage fibrosis.

Key Dates

First listed

Oct 27, 2025

Start date

Oct 24, 2025

Status verified

Jul 2026

Primary completion

Mar 29, 2028

Completion

Dec 12, 2031

Study Design

Enrollment

1,200 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Participants receiving dose level 1 of efimosfermin alfa
• Experimental: Participants receiving dose level 2 of efimosfermin alfa
• Placebo Comparator: Participants receiving Placebo

Primary Outcome Measure

Proportion of participants experiencing improvement in fibrosis by >=1 stage and no worsening of steatohepatitis at Week 52 [ Time Frame: At Week 52 ]

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 (76)

Find similar trials in Chandler, AZ

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