A Clinical Study to Investigate the Safety and Tolerability of Efimosfermin Alfa Injection in Participants With Known or Suspected 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
• Placebo — DRUG
  Placebo will be administered

Study Details

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.

Key Dates

Start date

Dec 12, 2025

Status verified

Mar 2026

Primary completion

Mar 24, 2028

Completion

Mar 24, 2028

Study Design

Enrollment

1,250 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Efimosfermin Alfa Dose Level 1
  Participants randomized to this group will receive Efimosfermin Alfa at dose level 1
• Experimental: Efimosfermin Alfa Dose Level 2
  Participants randomized to this group will receive Efimosfermin Alfa at dose level 2
• Placebo Comparator: Placebo
  Participants randomized to this group will receive Placebo

Primary Outcome Measure

Number of participants with treatment-emergent adverse events (TEAEs) and TEAEs by severity [ 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 (43)

Find similar trials in Arcadia, CA

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