Efimosfermin alfa: Efimosfermin alfa will be administered
Efimosfermin alfa: Efimosfermin alfa will be administered
Placebo: Placebo will be administered
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
1. Able and willing to understand and sign a written informed consent form that must be obtained prior to the initiation of study procedures
2. Age \>=18 and \<=75 years at enrollment
3. History or presence of 2 or more of the 5 components of metabolic syndrome per American Heart Association definition
4. Liver biopsy confirmation of MASH consistent with stage F2 or F3 fibrosis and a NAS score \>=4 confirmed by a central pathologist
Exclusion Criteria:
1. Contraindication or ineligibility for percutaneous liver biopsy
2. ALT or AST \>=5 x upper limit of normal (ULN)
3. 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.
4. Serum albumin \<=3.5 grams per deciliter (g/dL)
5. 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.
6. Alkaline phosphatase (ALP) \>=2\*ULN
7. 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.
8. 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
9. Alpha-fetoprotein \>=20 nanogram per milliliter (ng/mL)
10. Glycated hemoglobin \>=9.0%
11. Model for End-Stage Liver Disease score \>=12 unless the score is elevated in the absence of liver dysfunction (e.g., Gilbert's syndrome)
12. Phosphatidyl ethanol (PEth) \>=80 ng/mL at Screening
13. Evidence of infection with any of the following:
1. Human immunodeficiency virus;
2. Hepatitis B virus (detectable HBsAg at Screening);
3. Hepatitis C virus (HCV);
14. 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.
15. Current or history of excessive alcohol intake for \>=3 months within the 12-month period prior to Screening
Primary outcome measure(s)
Proportion of participants experiencing improvement in fibrosis by >=1 stage and no worsening of steatohepatitis at Week 52 — At Week 52 Proportion of participants experiencing improvement in fibrosis of greater than or equal to (\>=) 1 stage by MASH clinical research network (CRN) fibrosis scores and no worsening of steatohepatitis (defined as no increase in nonalcoholic fatty liver disease activity score \[NAS\] for ballooning, inflammation, or steatosis) at 52 weeks will be assessed. MASH CRN fibrosis score ranges from 0 to 4, higher score indicates greater severity. NAS score ranges from 0 to 8, higher score indicates worse disease activity.
Proportion of participants experiencing resolution of steatohepatitis reading and no worsening of MASH CRN fibrosis score at Week 52 — At Week 52 Resolution of steatohepatitis is defined as absence of fatty liver disease or isolated or simple steatosis without steatohepatitis and a NAS of 0 or 1 for inflammation, 0 for ballooning, and any value for steatosis. NAS score ranges from 0 to 8, higher score indicates worse disease activity. MASH CRN fibrosis score ranges from 0 to 4, higher score indicates greater severity.
Time from randomization to an adjudicated composite liver-related clinical outcome — From Randomization (Day 1) to 48 months Liver-related outcome will comprised of all-cause mortality; transplantation; occurrence of significant hepatic events.
Trial sites (91)
Facility
City
Region
Status
GSK Investigational Site
Chandler
Arizona
Recruiting
GSK Investigational Site
Tucson
Arizona
Recruiting
GSK Investigational Site
Little Rock
Arkansas
Recruiting
GSK Investigational Site
Arcadia
California
Recruiting
GSK Investigational Site
Covina
California
Recruiting
GSK Investigational Site
Folsom
California
Recruiting
GSK Investigational Site
Los Angeles
California
Recruiting
GSK Investigational Site
Montclair
California
Recruiting
GSK Investigational Site
Riverdale
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
Colorado Springs
Colorado
Recruiting
GSK Investigational Site
Boynton Beach
Florida
Recruiting
GSK Investigational Site
Cape Coral
Florida
Recruiting
GSK Investigational Site
Clermont
Florida
Recruiting
GSK Investigational Site
Fort Myers
Florida
Recruiting
GSK Investigational Site
Hialeah
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
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
Marietta
Georgia
Recruiting
GSK Investigational Site
Topeka
Kansas
Recruiting
GSK Investigational Site
Bastrop
Louisiana
Recruiting
GSK Investigational Site
Marrero
Louisiana
Recruiting
+ 51 more sites — see the full list on the official registry below.
Official registry record
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.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.