A Clinical Study to Investigate the Safety and Tolerability of Efimosfermin Alfa Injection in Participants With Known or Suspected F2- or F3-stage MASH
Efimosfermin Alfa: Efimosfermin Alfa will be administered
Placebo: Placebo will be administered
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Number of participants with treatment-emergent adverse events (TEAEs) and TEAEs by severity — At Week 52
Number of participants with TEAEs leading to discontinuation and TEAEs leading to discontinuation by severity — At Week 52
Number of participants with Grade 3 and Grade 4 laboratory abnormalities — At Week 52
Trial sites (66)
Facility
City
Region
Status
GSK Investigational Site
Arcadia
California
Recruiting
GSK Investigational Site
Covina
California
Recruiting
GSK Investigational Site
Los Angeles
California
Recruiting
GSK Investigational Site
San Diego
California
Recruiting
GSK Investigational Site
Santa Maria
California
Recruiting
GSK Investigational Site
Van Nuys
California
Recruiting
GSK Investigational Site
Boynton Beach
Florida
Recruiting
GSK Investigational Site
Cape Coral
Florida
Recruiting
GSK Investigational Site
Clermont
Florida
Recruiting
GSK Investigational Site
Doral
Florida
Recruiting
GSK Investigational Site
Fort Myers
Florida
Recruiting
GSK Investigational Site
Hialeah
Florida
Recruiting
GSK Investigational Site
Homestead
Florida
Recruiting
GSK Investigational Site
Inverness
Florida
Recruiting
GSK Investigational Site
Jacksonville
Florida
Recruiting
GSK Investigational Site
Kissimmee
Florida
Recruiting
GSK Investigational Site
Lakeland
Florida
Recruiting
GSK Investigational Site
Maitland
Florida
Recruiting
GSK Investigational Site
Miami
Florida
Recruiting
GSK Investigational Site
Miami
Florida
Recruiting
GSK Investigational Site
Miami
Florida
Recruiting
GSK Investigational Site
Miami
Florida
Recruiting
GSK Investigational Site
Miami
Florida
Recruiting
GSK Investigational Site
Miami
Florida
Recruiting
GSK Investigational Site
Miami Lakes
Florida
Recruiting
GSK Investigational Site
Ocala
Florida
Recruiting
GSK Investigational Site
Palmetto Bay
Florida
Recruiting
GSK Investigational Site
Sarasota
Florida
Recruiting
GSK Investigational Site
Topeka
Kansas
Recruiting
GSK Investigational Site
Marrero
Louisiana
Recruiting
GSK Investigational Site
Springfield
Missouri
Recruiting
GSK Investigational Site
St Louis
Missouri
Recruiting
GSK Investigational Site
St Louis
Missouri
Recruiting
GSK Investigational Site
Jersey City
New Jersey
Recruiting
GSK Investigational Site
East Syracuse
New York
Recruiting
GSK Investigational Site
New York
New York
Recruiting
GSK Investigational Site
Morehead City
North Carolina
Recruiting
GSK Investigational Site
Akron
Ohio
Recruiting
GSK Investigational Site
Springboro
Ohio
Recruiting
GSK Investigational Site
Chattanooga
Tennessee
Recruiting
+ 26 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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