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RecruitingPhase 3

A Pivotal Clinical Study to Investigate Efimosfermin Alfa in Participants With Biopsy-confirmed F2- or F3-stage MASH

GlaxoSmithKline · NCT07221227

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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
1200
US sites recruiting
76
Study start
October 24, 2025
Record last updated
July 27, 2026

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

What the study is about

The purpose of this study is to assess the safety and efficacy of efimosfermin alfa in the resolution of steatohepatitis and improvement of liver-related clinical outcome compared to placebo in individuals with MASH and biopsy-confirmed F2- or F3-stage fibrosis.

Being studied: Efimosfermin alfa; 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 that must be obtained prior to the initiation of study procedures
  • Age >=18 and \<=75 years at enrollment
  • History or presence of 2 or more of the 5 components of metabolic syndrome per American Heart Association definition
  • Liver biopsy confirmation of MASH consistent with stage F2 or F3 fibrosis and a NAS score >=4 confirmed by a central pathologist

Exclusion Criteria

  • Contraindication or ineligibility for percutaneous liver biopsy
  • ALT or AST >=5 x upper limit of normal (ULN)
  • Total bilirubin >=1.3 milligram per deciliter (mg/dL). Individuals with documented Gilbert's syndrome may be enrolled if they experienced an isolated increase in total bilirubin of >=1.3 mg/dL and direct bilirubin is \<=20% of total bilirubin; 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)
  • Glycated hemoglobin >=9.0%
  • Model for End-Stage Liver Disease score >=12 unless the score is elevated in the absence of liver dysfunction (e.g., Gilbert's syndrome)
  • Phosphatidyl ethanol (PEth) >=80 ng/mL at Screening
  • Evidence of infection with any of the following:
  • Human immunodeficiency virus;
  • Hepatitis B virus (detectable HBsAg at Screening);
  • Hepatitis C virus (HCV);
  • 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 on screening liver biopsy; 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

    Chandler, AZ 85224

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

  • GSK Investigational Site

    Tucson, AZ 85712

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

  • GSK Investigational Site

    Little Rock, AR 72211

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

  • 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

    Folsom, CA 95630

    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

    Montclair, CA 91763

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

  • GSK Investigational Site

    Riverdale, CA 30274

    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

    Colorado Springs, CO 80907

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

  • GSK Investigational Site

    Boynton Beach, FL 33435

    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

    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

    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

    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

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

  • GSK Investigational Site

    Miami, FL 33173

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

  • GSK Investigational Site

    Miami, FL 33176

    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

    Marietta, GA 30060

    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

    Bastrop, LA 71220

    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

    Kansas City, MO 64131

    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 63141

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

  • GSK Investigational Site

    Las Vegas, NV 89106

    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

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

  • GSK Investigational Site

    New York, NY 10036

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

  • GSK Investigational Site

    Fayetteville, NC 28304

    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

    Westlake, OH 44145

    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

    Arlington, TX 76012

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

  • GSK Investigational Site

    Austin, TX 78704

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

  • GSK Investigational Site

    Austin, TX 78757

    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

    Bellaire, TX 77401

    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

+ 16 more on the official record.

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 Pivotal Clinical Study to Investigate Efimosfermin Alfa in… (NCT07221227) | Bored Studies