Recruiting
Phase 3

Efimosfermin Alfa

Sponsor:

GlaxoSmithKline

Code:

NCT07701993

Conditions

Metabolic Dysfunction-associated Steatohepatitis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Efimosfermin alfa

Placebo

Study Details

Brief summary:

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

Conditions

Metabolic Dysfunction-associated Steatohepatitis

Study ID

NCT07701993

Start date

Jul 22, 2026

Status verified date

Aug, 2026

Completion date

Aug 24, 2033

Anticipated

Primary completion date

Jul 27, 2033

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Participants aged between 18 and 75 years at enrollment.
  • Participants with compensated cirrhosis due to MASH, confirmed by non-invasive assessments.
  • Participants with history or presence of at least two components of metabolic syndrome.

Exclusion Criteria:

  • Participants with other chronic liver diseases.
  • Participants with evidence or history of decompensated liver disease or hepatocellular carcinoma.
  • Participants with history of Type 1 diabetes mellitus or major Type 2 diabetes complications.
  • Participants with history or evidence of chronic pancreatic disease; pancreatic injury or acute pancreatitis within 6 months before screening.
  • Participants with a recent history or planned surgical procedures or medications intended to produce significant weight loss.
  • Participants with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >=5 times upper limit normal (ULN).
  • Participants with current or history of excessive alcohol intake.

Study Design

Enrollment

1740 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Participants receiving efimosfermin alfa

placebo comparator: Participants receiving placebo

Interventions

Efimosfermin alfa

Efimosfermin alfa (subcutaneous injection) will be administered.

Placebo

Placebo (subcutaneous injection) will be administered.

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 and Locations

Central contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

+44 (0) 20 89904466GSKClinicalSupportHD@gsk.com

Locations

GSK Investigational Site

Recruiting

Miami, Florida, United States, 33135

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Yaneicy Gonzalez Rojas

More Information

Sponsor

GlaxoSmithKline

Last update posted

Aug 5, 2026

Last verified

Aug, 2026

Keywords

  • Efimosfermin alfa
  • Metabolic dysfunction-associated
  • steatohepatitis
  • Fibrosis
  • Cirrhosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by GlaxoSmithKline on 2026-08-05.