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NCT07221227PHASE3Recruiting

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

GlaxoSmithKline

Start Date

10/24/2025

Completion Date

12/12/2031

Summary

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.

Eligibility Criteria

Age Range: 18 years to 75 years

Inclusion Criteria: 1. Able and willing to understand and sign a written informed consent form that must be obtained prior to the initiation of study procedures 2. Age \>=18 and \<=75 years at enrollment 3. History or presence of 2 or more of the 5 components of metabolic syndrome per American Heart Association definition 4. Liver biopsy confirmation of MASH consistent with stage F2 or F3 fibrosis and a NAS score \>=4 confirmed by a central pathologist Exclusion Criteria: 1. Contraindication or ineligibility for percutaneous liver biopsy 2. ALT or AST \>=5 x upper limit of normal (ULN) 3. 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. 4. Serum albumin \<=3.5 grams per deciliter (g/dL) 5. 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. 6. Alkaline phosphatase (ALP) \>=2\*ULN 7. 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. 8. 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 9. Alpha-fetoprotein \>=20 nanogram per milliliter (ng/mL) 10. Glycated hemoglobin \>=9.0% 11. Model for End-Stage Liver Disease score \>=12 unless the score is elevated in the absence of liver dysfunction (e.g., Gilbert's syndrome) 12. Phosphatidyl ethanol (PEth) \>=80 ng/mL at Screening 13. Evidence of infection with any of the following: 1. Human immunodeficiency virus; 2. Hepatitis B virus (detectable HBsAg at Screening); 3. Hepatitis C virus (HCV); 14. 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. 15. Current or history of excessive alcohol intake for \>=3 months within the 12-month period prior to Screening

Interventions

DRUG

Efimosfermin alfa

DRUG

Efimosfermin alfa

DRUG

Placebo

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Conditions

Non-alcoholic Fatty Liver Disease

Locations

GSK Investigational Site

Chandler, Arizona 85224

United States

GSK Investigational Site

Tucson, Arizona 85712

United States

GSK Investigational Site

Little Rock, Arkansas 72211

United States

GSK Investigational Site

Arcadia, California 91006

United States

GSK Investigational Site

Covina, California 91723

United States

GSK Investigational Site

Folsom, California 95630

United States

GSK Investigational Site

Los Angeles, California 90057

United States

GSK Investigational Site

Montclair, California 91763

United States

GSK Investigational Site

Riverdale, California 30274

United States

GSK Investigational Site

San Diego, California 92120

United States

GSK Investigational Site

Santa Maria, California 93458

United States

GSK Investigational Site

Van Nuys, California 91405

United States

GSK Investigational Site

Colorado Springs, Colorado 80907

United States

GSK Investigational Site

Boynton Beach, Florida 33435

United States

GSK Investigational Site

Cape Coral, Florida 33914

United States

GSK Investigational Site

Clermont, Florida 34711

United States

GSK Investigational Site

Fort Myers, Florida 33912

United States

GSK Investigational Site

Hialeah, Florida 33016

United States

GSK Investigational Site

Hialeah, Florida 33016

United States

GSK Investigational Site

Homestead, Florida 33033

United States

GSK Investigational Site

Inverness, Florida 34452

United States

GSK Investigational Site

Jacksonville, Florida 32216

United States

GSK Investigational Site

Kissimmee, Florida 34744

United States

GSK Investigational Site

Lakeland, Florida 33803

United States

GSK Investigational Site

Maitland, Florida 32751

United States

GSK Investigational Site

Miami, Florida 33135

United States

GSK Investigational Site

Miami, Florida 33144

United States

GSK Investigational Site

Miami, Florida 33155

United States

GSK Investigational Site

Miami, Florida 33156

United States

GSK Investigational Site

Miami, Florida 33173

United States

GSK Investigational Site

Miami, Florida 33176

United States

GSK Investigational Site

Miami, Florida 33184

United States

GSK Investigational Site

Miami Lakes, Florida 33014

United States

GSK Investigational Site

Ocala, Florida 34471

United States

GSK Investigational Site

Palmetto Bay, Florida 33157

United States

GSK Investigational Site

Sarasota, Florida 34201

United States

GSK Investigational Site

Marietta, Georgia 30060

United States

GSK Investigational Site

Topeka, Kansas 66606

United States

GSK Investigational Site

Bastrop, Louisiana 71220

United States

GSK Investigational Site

Marrero, Louisiana 70072

United States

GSK Investigational Site

Kansas City, Missouri 64131

United States

GSK Investigational Site

Springfield, Missouri 62703

United States

GSK Investigational Site

St Louis, Missouri 63141

United States

GSK Investigational Site

Las Vegas, Nevada 89106

United States

GSK Investigational Site

East Syracuse, New York 13057

United States

GSK Investigational Site

New York, New York 10036

United States

GSK Investigational Site

New York, New York 10036

United States

GSK Investigational Site

Fayetteville, North Carolina 28304

United States

GSK Investigational Site

Morehead City, North Carolina 28557

United States

GSK Investigational Site

Akron, Ohio 44320

United States

GSK Investigational Site

Springboro, Ohio 45066

United States

GSK Investigational Site

Westlake, Ohio 44145

United States

GSK Investigational Site

Chattanooga, Tennessee 37421

United States

GSK Investigational Site

Arlington, Texas 76012

United States

GSK Investigational Site

Austin, Texas 78704

United States

GSK Investigational Site

Austin, Texas 78757

United States

GSK Investigational Site

Austin, Texas 78759

United States

GSK Investigational Site

Bellaire, Texas 77401

United States

GSK Investigational Site

Brownsville, Texas 78526

United States

GSK Investigational Site

Dallas, Texas 75243

United States

GSK Investigational Site

DeSoto, Texas 75115

United States

GSK Investigational Site

Houston, Texas 77004

United States

GSK Investigational Site

Irving, Texas 75061

United States

GSK Investigational Site

Richmond, Texas 77406

United States

GSK Investigational Site

San Antonio, Texas 78209

United States

GSK Investigational Site

San Antonio, Texas 78215

United States

GSK Investigational Site

San Antonio, Texas 78229

United States

GSK Investigational Site

Seabrook, Texas 77586

United States

GSK Investigational Site

Sugar Land, Texas 77479

United States

GSK Investigational Site

Tomball, Texas 77375

United States

GSK Investigational Site

Waco, Texas 76710

United States

GSK Investigational Site

Waco, Texas 76712

United States

GSK Investigational Site

West Jordan, Utah 84088

United States

GSK Investigational Site

Manassas, Virginia 20110

United States

GSK Investigational Site

Norfolk, Virginia 23502

United States

GSK Investigational Site

Seattle, Washington 98105

United States

GSK Investigational Site

Broadmeadow, New South Wales 2292

Australia

GSK Investigational Site

Heidelberg, Victoria 3084

Australia

GSK Investigational Site

Québec, Quebec G1N 4V3

Canada

GSK Investigational Site

Pokfulam,

Hong Kong

GSK Investigational Site

Gifu, 503-8502

Japan

GSK Investigational Site

Kanagawa, 215-0026

Japan

GSK Investigational Site

Kyoto, 602-8566

Japan

GSK Investigational Site

Musashino, 180-8610

Japan

GSK Investigational Site

Yokohama, 236-0004

Japan

GSK Investigational Site

Wellington, 6021

New Zealand

GSK Investigational Site

San Juan, 00927

Puerto Rico

GSK Investigational Site

Riyadh, 11472

Saudi Arabia

GSK Investigational Site

Chiayi City, 600

Taiwan

GSK Investigational Site

Kaohsiung City, 80756

Taiwan

GSK Investigational Site

Kaohsiung City, 83301

Taiwan