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RecruitingPhase 3

A Clinical Study to Investigate the Safety and Tolerability of Efimosfermin Alfa Injection in Participants With Known or Suspected F2- or F3-stage MASH

GlaxoSmithKline · NCT07221188

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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
1250
US sites recruiting
58
Study start
December 12, 2025
Record last updated
September 17, 2026

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

What the study is about

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.

Being studied: Efimosfermin Alfa; Placebo

Conditions: Non-alcoholic Fatty Liver Disease

Eligibility criteria

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

Show full criteria

Inclusion Criteria

  • Able and willing to understand and sign a written informed consent form (ICF) that must be obtained prior to the initiation of study procedures
  • Age >=18 through \<=75 years at enrolment
  • History or presence of 2 or more of the 5 components of metabolic syndrome per American Heart Association definition
  • History or presence of known or suspected MASH with evidence of fibrosis

Exclusion Criteria

  • ALT or AST >=5 × upper limit of normal (ULN)
  • Total bilirubin (BILI) >=1.3 milligram per deciliter (mg/dL). Individuals with documented Gilbert's syndrome may be enrolled if they experienced an isolated increase in total BILI of >=1.3 mg/dL and direct BILI is \<=20% of total BILI; otherwise, the individual will be excluded.
  • Serum albumin \<=3.5 grams per deciliter (g/dL)
  • International normalized ratio (INR) >=1.3 not due to therapeutic anticoagulation. Individuals receiving chronic anticoagulant treatment with higher INR values may be enrolled at the discretion of the Investigator and Study Medical Monitor.
  • Alkaline phosphatase (ALP) >=2 × ULN
  • Platelet (PLT) count \<140 000 per (/) cubic millimeter (mm\^3); individuals with a PLT count between 110,000/mm\^3 and 140,000/mm\^3 may be enrolled after discussion with the Study Medical Monitor
  • Serum creatinine >=1.5 mg/dL or creatinine clearance \<=60 milliliter (mL)/minute (min)/1.73 square meter by Chronic Kidney Disease Epidemiology Collaboration equation.
  • Alpha-fetoprotein >=20 nanogram per milliliter (ng/mL)
  • HbA1c >=9.0%
  • Model for End-Stage Liver Disease (MELD) 3.0 score >=12 unless the score is elevated in the absence of liver dysfunction (eg, Gilbert's syndrome)
  • Phosphatidylethanol (PEth) >=80 nanogram per milliliter (ng/mL) at Screening
  • Known co-infection with any of the following: a. Human immunodeficiency virus; b. Hepatitis B virus; c. Hepatitis C virus (HCV); d. Hepatitis D virus; or e. Hepatitis E virus.
  • Chronic liver disease from any other cause including, but not limited to, alcoholic liver disease; evidence of portal hypertension; viral hepatitis, or any history or evidence of cirrhosis; or decompensated liver disease such as clinical ascites, bleeding gastroesophageal varices, hepatorenal syndrome, or hepatic encephalopathy prior to Screening or Day 1.
  • Current or history of excessive alcohol intake for >=3 months within the 12-month period prior to Screening

Recruiting US locations

  • GSK Investigational Site

    Arcadia, CA 91006

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

  • GSK Investigational Site

    Covina, CA 91723

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

  • GSK Investigational Site

    Los Angeles, CA 90057

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

  • GSK Investigational Site

    San Diego, CA 92120

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

  • GSK Investigational Site

    Santa Maria, CA 93458

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

  • GSK Investigational Site

    Van Nuys, CA 91405

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

  • GSK Investigational Site

    Boynton Beach, FL 33435-5610

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

  • GSK Investigational Site

    Cape Coral, FL 33914

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

  • GSK Investigational Site

    Clermont, FL 34711

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

  • GSK Investigational Site

    Doral, FL 33016

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

  • GSK Investigational Site

    Fort Myers, FL 33912

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

  • GSK Investigational Site

    Hialeah, FL 33016

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

  • GSK Investigational Site

    Homestead, FL 33033

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

  • GSK Investigational Site

    Inverness, FL 34452

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

  • GSK Investigational Site

    Jacksonville, FL 32216

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

  • GSK Investigational Site

    Kissimmee, FL 34744

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

  • GSK Investigational Site

    Lakeland, FL 33803

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

  • GSK Investigational Site

    Maitland, FL 32751

    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 33144

    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

    Miami, FL 33156-7397

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

  • GSK Investigational Site

    Miami, FL 33173-3484

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

  • GSK Investigational Site

    Miami, FL 33184

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

  • GSK Investigational Site

    Miami Lakes, FL 33014

    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

    Palmetto Bay, FL 33157

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

  • GSK Investigational Site

    Sarasota, FL 34201

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

  • GSK Investigational Site

    Topeka, KS 66606

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

  • GSK Investigational Site

    Marrero, LA 70072

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

  • GSK Investigational Site

    Springfield, MO 62703

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

  • GSK Investigational Site

    St Louis, MO 63123

    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

    Jersey City, NJ 07059

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

  • GSK Investigational Site

    East Syracuse, NY 13057

    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

    Akron, OH 44320

    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

    Chattanooga, TN 37421

    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

    Austin, TX 78759

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

  • GSK Investigational Site

    Brownsville, TX 78526

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

  • GSK Investigational Site

    Dallas, TX 75243

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

  • GSK Investigational Site

    DeSoto, TX 75115

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

  • GSK Investigational Site

    Richmond, TX 77406

    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

  • GSK Investigational Site

    San Antonio, TX 78229

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

  • GSK Investigational Site

    Seabrook, TX 77586

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

  • GSK Investigational Site

    Sugar Land, TX 77479

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

  • GSK Investigational Site

    Sugar Land, TX 77479

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

  • GSK Investigational Site

    Tomball, TX 77375

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

  • GSK Investigational Site

    Waco, TX 76710

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

  • GSK Investigational Site

    Waco, TX 76712

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

  • GSK Investigational Site

    West Jordan, UT 84088

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

  • GSK Investigational Site

    Manassas, VA 20110

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

  • GSK Investigational Site

    Seattle, WA 98105

    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
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A Clinical Study to Investigate the Safety and Tolerability of… (NCT07221188) | Bored Studies