Tests efimosfermin alfa in adults with liver scarring from fatty liver disease
Tests efimosfermin alfa against placebo in adults with MASH and moderate liver scarring.
Plain-language title generated from the registry record
Registry title: A Pivotal Clinical Study to Investigate Efimosfermin Alfa in Participants With Biopsy-confirmed F2- or F3-stage MASH
Key facts
- Where
- Québec, CanadaSee the site
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07221227, who can take part
Where in Canada
- QuébecQuébec, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- GlaxoSmithKline
- Trial code
- NCT07221227
- Record updated
- 27 July 2026
- Original description
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.Read full original descriptionShow less
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 3-Arm Study to Investigate the Safety and Efficacy of Efimosfermin Alfa in Participants With Biopsy-Confirmed F2- or F3-Stage Metabolic Dysfunction-Associated Steatohepatitis (MASH) (ZENITH-1)
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.
Inclusion: 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: 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; Model for End-Stage Liver Disease score >=12 unless the score is elevated in the absence of liver dysfunction (e.g., Gilbert's syndrome); Evidence of infection with any of the following:; Human immunodeficiency virus; Hepatitis B virus (detectable HBsAg at Screening); Hepatitis C virus (HCV); 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; Glycated hemoglobin >=9.0%; Contraindication or ineligibility for percutaneous liver biopsy; Alpha-fetoprotein >=20 nanogram per milliliter (ng/mL); Phosphatidyl ethanol (PEth) >=80 ng/mL at Screening.