A Pivotal Clinical Study to Investigate the Safety and Efficacy of Efimosfermin Compared With Placebo in Adult Participants With Compensated Cirrhosis Due to Metabolic Dysfunction-associated Steatohepatitis (MASH)

Part of paid clinical trials in Miami, Florida.

Sponsor
GlaxoSmithKline
Study ID
NCT07701993
Phase
PHASE3
Status
Recruiting
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Conditions

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 study will investigate the safety and efficacy of efimosfermin alfa in participants with compensated cirrhosis due to MASH.

Key Dates

First listed
Jul 14, 2026
Start date
Jul 22, 2026
Status verified
Aug 2026
Primary completion
Jul 27, 2033
Completion
Aug 24, 2033

Study Design

Enrollment
1,740 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Participants receiving efimosfermin alfa
  • Placebo Comparator: Participants receiving placebo

Primary Outcome Measure

Time from randomization to an adjudicated composite liver-related clinical outcome [ Time Frame: From Randomization (Day 1) to Week 356 (end of treatment) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteMiamiFlorida33135
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Yaneicy Gonzalez Rojas (PRINCIPAL_INVESTIGATOR)

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GSK Investigational Site· Miami, FL

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