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RecruitingPhase 3

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

GlaxoSmithKline · NCT07704892

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–75 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
380
US sites recruiting
18
Study start
July 22, 2026
Record last updated
September 30, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

This is a multi-center, randomized, two-part (Part A and Part B) study investigating the safety and efficacy of efimosfermin alfa in adult participants with compensated cirrhosis due to MASH. Participants who complete the treatment during Part A of the study and meet the inclusion criteria will have the option to enroll in Part B (open label) of the study.

Being studied: Efimosfermin alfa; Placebo

Conditions: Metabolic Dysfunction-associated Steatohepatitis

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • Participants aged between 18 and 75 years at enrolment.
  • Participants with history or presence of at least two components of metabolic syndrome.
  • Liver biopsy consistent with cirrhosis (fibrosis stage 4).

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 mellitus complications.
  • History or evidence of chronic pancreatic disease; pancreatic injury or acute pancreatitis within 6 months before Screening.
  • A recent history or planned surgical procedures or medications intended to produce significant weight loss.
  • Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) >= 5 times upper limit normal (ULN).
  • Current or history of excessive alcohol intake

Recruiting US locations

  • GSK Investigational Site

    Little Rock, AR 72211

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Folsom, CA 95630

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Miami, FL 33135-4661

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Miami, FL 33155

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Ocala, FL 34471

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    St Louis, MO 63141

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    New York, NY 10036-4103

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Morehead City, NC 28557

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Springboro, OH 45066

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Westlake, OH 44145-1493

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Arlington, TX 76012

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Austin, TX 78745-5675

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Bellaire, TX 77401

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Dallas, TX 75243-1921

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Houston, TX 77058

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Humble, TX 77346

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    San Antonio, TX 78209

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    San Antonio, TX 78215

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

Study contacts (from the official record)

  • US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
  • EU GSK Clinical Trials Call Center · +44 (0) 20 89904466 · GSKClinicalSupportHD@gsk.com
A Study to Investigate Safety and Efficacy of Efimosfermin… (NCT07704892) | Bored Studies