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

Sep, 2026

Completion date

Aug 24, 2033

Anticipated

Primary completion date

Jun 23, 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

Little Rock, Arkansas, United States, 72211

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:

John Baber

GSK Investigational Site

Recruiting

Folsom, California, United States, 95630

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:

Nazir Rahim

GSK Investigational Site

Recruiting

Miami, Florida, United States, 33135-4661

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

GSK Investigational Site

Recruiting

Miami, Florida, United States, 33155

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:

Jorge Amaya

GSK Investigational Site

Recruiting

Ocala, Florida, United States, 34471

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:

Robert Barish

GSK Investigational Site

Recruiting

St Louis, Missouri, United States, 63141

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:

Brian Mcmorrow

GSK Investigational Site

Recruiting

Arlington, Texas, United States, 76012

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:

Reem Ghalib

GSK Investigational Site

Recruiting

Austin, Texas, United States, 78745-5675

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:

Nomita Kim

GSK Investigational Site

Recruiting

Bellaire, Texas, United States, 77401

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:

Everald Manning

GSK Investigational Site

Recruiting

Dallas, Texas, United States, 75243-1921

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:

Valentine Ebuh

GSK Investigational Site

Recruiting

Humble, Texas, United States, 77346

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:

Brian Chou

GSK Investigational Site

Recruiting

San Antonio, Texas, United States, 78209

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:

Robert Morin Jr

GSK Investigational Site

Recruiting

San Antonio, Texas, United States, 78215

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:

Eric Lawitz

More Information

Sponsor

GlaxoSmithKline

Last update posted

Sep 30, 2026

Last verified

Sep, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by GlaxoSmithKline on 2026-09-30. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.