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

Recruiting · NCT07221227 · Interventional (participants receive a specific treatment) · Lead sponsor: GlaxoSmithKline

View the official record on ClinicalTrials.gov →

Interventions studied

What this trial is about

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.

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 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

Where it is running

60 locations listed across 18 US states.

GSK Investigational Site - Chandler, Arizona, United States
GSK Investigational Site - Tucson, Arizona, United States
GSK Investigational Site - Little Rock, Arkansas, United States
GSK Investigational Site - Arcadia, California, United States
GSK Investigational Site - Covina, California, United States
GSK Investigational Site - Folsom, California, United States
GSK Investigational Site - Los Angeles, California, United States
GSK Investigational Site - Montclair, California, United States
GSK Investigational Site - Riverdale, 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 - Colorado Springs, Colorado, 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 - Fort Myers, Florida, United States
GSK Investigational Site - Hialeah, 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, 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 - Marietta, Georgia, United States
GSK Investigational Site - Topeka, Kansas, United States
GSK Investigational Site - Bastrop, Louisiana, United States
GSK Investigational Site - Marrero, Louisiana, United States
GSK Investigational Site - Kansas City, Missouri, United States
GSK Investigational Site - Springfield, Missouri, United States
GSK Investigational Site - St Louis, Missouri, United States
GSK Investigational Site - Las Vegas, Nevada, United States
GSK Investigational Site - East Syracuse, New York, United States
GSK Investigational Site - New York, New York, United States
GSK Investigational Site - New York, New York, United States
GSK Investigational Site - Fayetteville, North Carolina, 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 - Westlake, Ohio, United States
GSK Investigational Site - Chattanooga, Tennessee, United States
GSK Investigational Site - Arlington, Texas, United States
GSK Investigational Site - Austin, Texas, United States
GSK Investigational Site - Austin, Texas, United States
GSK Investigational Site - Austin, Texas, United States
GSK Investigational Site - Bellaire, Texas, United States
GSK Investigational Site - Brownsville, Texas, United States
GSK Investigational Site - Dallas, Texas, United States

Showing 60 of 91 listed sites. See the official record for the complete list.

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