Phase
Condition
Liver Disease
Treatment
Efimosfermin Alfa
Placebo
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Able and willing to understand and sign a written informed consent form (ICF) thatmust 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 perAmerican Heart Association definition
History or presence of known or suspected MASH with evidence of fibrosis
Exclusion
Exclusion Criteria:
ALT or AST >=5 × upper limit of normal (ULN)
Total bilirubin (BILI) >=1.3 milligram per deciliter (mg/dL). Individuals withdocumented Gilbert's syndrome may be enrolled if they experienced an isolatedincrease 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 beenrolled 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 aPLT count between 110,000/mm^3 and 140,000/mm^3 may be enrolled after discussionwith 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 Collaborationequation.
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 elevatedin 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. HepatitisE virus.
Chronic liver disease from any other cause including, but not limited to, alcoholicliver disease; evidence of portal hypertension; viral hepatitis, or any history orevidence of cirrhosis; or decompensated liver disease such as clinical ascites,bleeding gastroesophageal varices, hepatorenal syndrome, or hepatic encephalopathyprior to Screening or Day 1.
Current or history of excessive alcohol intake for >=3 months within the 12-monthperiod prior to Screening
Study Design
Connect with a study center
GSK Investigational Site
Arcadia, California 91006
United StatesActive - Recruiting
GSK Investigational Site
Covina, California 91723
United StatesActive - Recruiting
GSK Investigational Site
Los Angeles, California 90057
United StatesActive - Recruiting
GSK Investigational Site
Santa Maria, California 93458
United StatesActive - Recruiting
GSK Investigational Site
Cape Coral, Florida 33914
United StatesActive - Recruiting
GSK Investigational Site
Doral, Florida 33016
United StatesActive - Recruiting
GSK Investigational Site
Hialeah, Florida 33016
United StatesActive - Recruiting
GSK Investigational Site
Inverness, Florida 34452
United StatesActive - Recruiting
GSK Investigational Site
Jacksonville, Florida 32216
United StatesActive - Recruiting
GSK Investigational Site
Kissimmee, Florida 34744
United StatesActive - Recruiting
GSK Investigational Site
Lakeland, Florida 33803
United StatesActive - Recruiting
GSK Investigational Site
Maitland, Florida 32751
United StatesActive - Recruiting
GSK Investigational Site
Miami, Florida 33155
United StatesActive - Recruiting
GSK Investigational Site
Miami Lakes, Florida 33014
United StatesActive - Recruiting
GSK Investigational Site
Ocala, Florida 34471
United StatesActive - Recruiting
GSK Investigational Site
Palmetto Bay, Florida 33157
United StatesActive - Recruiting
GSK Investigational Site
Miami 4164138, Florida 4155751 33135
United StatesSite Not Available
GSK Investigational Site
Ocala 4166673, Florida 4155751 34471
United StatesSite Not Available
GSK Investigational Site
Topeka, Kansas 66606
United StatesActive - Recruiting
GSK Investigational Site
Springfield, Missouri 62703
United StatesActive - Recruiting
GSK Investigational Site
St Louis, Missouri 63141
United StatesActive - Recruiting
GSK Investigational Site
St Louis 4407066, Missouri 4398678 63141
United StatesSite Not Available
GSK Investigational Site
Jersey City, New Jersey 07059
United StatesActive - Recruiting
GSK Investigational Site
East Syracuse, New York 13057
United StatesActive - Recruiting
GSK Investigational Site
New York, New York 10036
United StatesActive - Recruiting
GSK Investigational Site
Morehead City, North Carolina 28557
United StatesActive - Recruiting
GSK Investigational Site
Akron, Ohio 44320
United StatesActive - Recruiting
GSK Investigational Site
Springboro, Ohio 45066
United StatesActive - Recruiting
GSK Investigational Site
Austin, Texas 78745
United StatesActive - Recruiting
GSK Investigational Site
Brownsville, Texas 78526
United StatesActive - Recruiting
GSK Investigational Site
Dallas, Texas 75243
United StatesActive - Recruiting
GSK Investigational Site
DeSoto, Texas 75115
United StatesActive - Recruiting
GSK Investigational Site
Richmond, Texas 77406
United StatesActive - Recruiting
GSK Investigational Site
San Antonio, Texas 78215
United StatesActive - Recruiting
GSK Investigational Site
Seabrook, Texas 77586
United StatesActive - Recruiting
GSK Investigational Site
Tomball, Texas 77375
United StatesActive - Recruiting
GSK Investigational Site
Waco, Texas 76710
United StatesActive - Recruiting
GSK Investigational Site
San Antonio 4726206, Texas 4736286 78215
United StatesSite Not Available
GSK Investigational Site
Waco 4739526, Texas 4736286 76712
United StatesSite Not Available
GSK Investigational Site
West Jordan, Utah 84088
United StatesActive - Recruiting
GSK Investigational Site
Manassas, Virginia 20110
United StatesActive - Recruiting
GSK Investigational Site
Seattle, Washington 98105
United StatesActive - Recruiting

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