A Pivotal Clinical Study to Investigate Efimosfermin Alfa in Participants With Biopsy-confirmed F2- or F3-stage MASH | NCT07221227 | Trialant

A Pivotal Clinical Study to Investigate Efimosfermin Alfa in Participants With Biopsy-confirmed F2- or F3-stage MASH | NCT07221227 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility 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

GSK Investigational SiteRecruiting

Chandler, Arizona 85224, United States

US GSK Clinical Trials Call CenterContact

GSKClinicalSupportHD@gsk.com877-379-3718

EU GSK Clinical Trials Call CentreContact

GSKClinicalSupportHD@gsk.com+44 (0) 20 8990 4466

Anita KohliPrincipal Investigator

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Tucson, Arizona 85712, United States

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Little Rock, Arkansas 72211, United States

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Arcadia, California 91006, United States

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Covina, California 91723, United States

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Folsom, California 95630, United States

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Los Angeles, California 90057, United States

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Montclair, California 91763, United States

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Riverdale, California 30274, United States

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San Diego, California 92120, United States

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Santa Maria, California 93458, United States

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Van Nuys, California 91405, United States

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Colorado Springs, Colorado 80907, United States

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Boynton Beach, Florida 33435, United States

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Cape Coral, Florida 33914, United States

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Clermont, Florida 34711, United States

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Fort Myers, Florida 33912, United States

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Hialeah, Florida 33016, United States

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Hialeah, Florida 33016, United States

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Homestead, Florida 33033, United States

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Inverness, Florida 34452, United States

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Jacksonville, Florida 32216, United States

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Kissimmee, Florida 34744, United States

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Lakeland, Florida 33803, United States

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Maitland, Florida 32751, United States

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Miami, Florida 33135, United States

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Miami, Florida 33144, United States

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Miami, Florida 33155, United States

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Miami, Florida 33156, United States

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Miami, Florida 33173, United States

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Miami, Florida 33176, United States

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Miami, Florida 33184, United States

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Miami Lakes, Florida 33014, United States

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Ocala, Florida 34471, United States

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Palmetto Bay, Florida 33157, United States

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Sarasota, Florida 34201, United States

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Topeka, Kansas 66606, United States

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Bastrop, Louisiana 71220, United States

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Marrero, Louisiana 70072, United States

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Kansas City, Missouri 64131, United States

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Springfield, Missouri 62703, United States

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St Louis, Missouri 63141, United States

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Las Vegas, Nevada 89106, United States

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East Syracuse, New York 13057, United States

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New York, New York 10036, United States

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New York, New York 10036, United States

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Fayetteville, North Carolina 28304, United States

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Morehead City, North Carolina 28557, United States

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Akron, Ohio 44320, United States

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Springboro, Ohio 45066, United States

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Westlake, Ohio 44145, United States

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Chattanooga, Tennessee 37421, United States

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Arlington, Texas 76012, United States

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Austin, Texas 78704, United States

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Austin, Texas 78757, United States

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Austin, Texas 78759, United States

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Bellaire, Texas 77401, United States

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Brownsville, Texas 78526, United States

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DeSoto, Texas 75115, United States

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Houston, Texas 77004, United States

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Irving, Texas 75061, United States

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Richmond, Texas 77406, United States

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San Antonio, Texas 78209, United States

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San Antonio, Texas 78215, United States

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Waco, Texas 76712, United States

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Manassas, Virginia 20110, United States

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Norfolk, Virginia 23502, United States

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Seattle, Washington 98105, United States

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Broadmeadow, New South Wales 2292, Australia

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Heidelberg, Victoria 3084, Australia

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Québec, Quebec G1N 4V3, Canada

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Pokfulam, Hong Kong

US GSK Clinical Trials Call CenterContact

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Gifu, 503-8502, Japan

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Kanagawa, 215-0026, Japan

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Kyoto, 602-8566, Japan

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Musashino, 180-8610, Japan

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Yokohama, 236-0004, Japan

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Wellington, 6021, New Zealand

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San Juan, 00927, Puerto Rico

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Riyadh, 11472, Saudi Arabia

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Chiayi City, 600, Taiwan

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Kaohsiung City, 80756, Taiwan

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Kaohsiung City, 83301, Taiwan