A Clinical Study to Investigate the Safety and Tolerability of Efimosfermin Alfa Injection in Participants With Known or Suspected F2- or F3-stage MASH

Recruiting · NCT07221188 · Interventional (participants receive a specific treatment) · Lead sponsor: GlaxoSmithKline

View the official record on ClinicalTrials.gov →

Interventions studied

What this trial is about

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.

Who can take part

Age range

18 Years to 75 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Phase 3

Study type

Interventional (participants receive a specific treatment)

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

Where it is running

60 locations listed across 14 US states.

GSK Investigational Site - Arcadia, California, United States
GSK Investigational Site - Covina, California, United States
GSK Investigational Site - Los Angeles, California, United States
GSK Investigational Site - San Diego, California, United States
GSK Investigational Site - Santa Maria, California, United States
GSK Investigational Site - Van Nuys, California, United States
GSK Investigational Site - Boynton Beach, Florida, United States
GSK Investigational Site - Cape Coral, Florida, United States
GSK Investigational Site - Clermont, Florida, United States
GSK Investigational Site - Doral, Florida, United States
GSK Investigational Site - Fort Myers, Florida, United States
GSK Investigational Site - Hialeah, Florida, United States
GSK Investigational Site - Homestead, Florida, United States
GSK Investigational Site - Inverness, Florida, United States
GSK Investigational Site - Jacksonville, Florida, United States
GSK Investigational Site - Kissimmee, Florida, United States
GSK Investigational Site - Lakeland, Florida, United States
GSK Investigational Site - Maitland, Florida, United States
GSK Investigational Site - Miami, Florida, United States
GSK Investigational Site - Miami, Florida, United States
GSK Investigational Site - Miami, Florida, United States
GSK Investigational Site - Miami, Florida, United States
GSK Investigational Site - Miami, Florida, United States
GSK Investigational Site - Miami, Florida, United States
GSK Investigational Site - Miami Lakes, Florida, United States
GSK Investigational Site - Ocala, Florida, United States
GSK Investigational Site - Palmetto Bay, Florida, United States
GSK Investigational Site - Sarasota, Florida, United States
GSK Investigational Site - Topeka, Kansas, United States
GSK Investigational Site - Marrero, Louisiana, United States
GSK Investigational Site - Springfield, Missouri, United States
GSK Investigational Site - St Louis, Missouri, United States
GSK Investigational Site - St Louis, Missouri, United States
GSK Investigational Site - Jersey City, New Jersey, United States
GSK Investigational Site - East Syracuse, New York, United States
GSK Investigational Site - New York, New York, United States
GSK Investigational Site - Morehead City, North Carolina, United States
GSK Investigational Site - Akron, Ohio, United States
GSK Investigational Site - Springboro, Ohio, United States
GSK Investigational Site - Chattanooga, Tennessee, United States
GSK Investigational Site - Austin, Texas, United States
GSK Investigational Site - Austin, Texas, United States
GSK Investigational Site - Brownsville, Texas, United States
GSK Investigational Site - Dallas, Texas, United States
GSK Investigational Site - DeSoto, Texas, United States
GSK Investigational Site - Richmond, Texas, United States
GSK Investigational Site - San Antonio, Texas, United States
GSK Investigational Site - San Antonio, Texas, United States
GSK Investigational Site - San Antonio, Texas, United States
GSK Investigational Site - Seabrook, Texas, United States
GSK Investigational Site - Sugar Land, Texas, United States
GSK Investigational Site - Sugar Land, Texas, United States
GSK Investigational Site - Tomball, Texas, United States
GSK Investigational Site - Waco, Texas, United States
GSK Investigational Site - Waco, Texas, United States
GSK Investigational Site - West Jordan, Utah, United States
GSK Investigational Site - Manassas, Virginia, United States
GSK Investigational Site - Seattle, Washington, United States
GSK Investigational Site - Gunma, Japan
GSK Investigational Site - Kagoshima, Japan

Showing 60 of 66 listed sites. See the official record for the complete list.

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →