Tests efimosfermin alfa injection in adults with fatty liver scarring
Tests efimosfermin alfa injection for safety in adults with MASH liver disease.
Plain-language title generated from the registry record
Registry title: A Clinical Study to Investigate the Safety and Tolerability of Efimosfermin Alfa Injection in Participants With Known or Suspected F2- or F3-stage MASH
Key facts
- Where
- Berlin, Hamburg, Heidelberg, Homburg, Leipzig, Mainz, and Muenster, GermanySee the 9 sites
- 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: NCT07221188, who can take part
Where in Germany
- Charite Universitaetsmedizin Berlin KöRBerlin, GermanyTaking people
- Epimed Gesellschaft fuer epidemiologische und klinische Forschung in der Medizin mbHBerlin, GermanyTaking people
- University Medical Center Hamburg-EppendorfHamburg, GermanyTaking people
- Universitaetsklinikum Heidelberg AöRHeidelberg, GermanyTaking people
- Universitaet Des SaarlandesHomburg, GermanyTaking people
- Eugastro GmbHLeipzig, GermanyTaking people
- Universitaet LeipzigLeipzig, GermanyTaking people
- Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöRMainz, GermanyTaking people
- Universitaet MuensterMuenster, GermanyTaking 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
- NCT07221188EU 2025-523674-16-00
- Record updated
- 17 September 2026
- Original description
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.Read full original descriptionShow less
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 3-Arm Study to Investigate the Safety and Tolerability of Efimosfermin Alfa in Participants With Known or Suspected F2- or F3-Stage Metabolic Dysfunction-Associated Steatohepatitis (MASH) (ZENITH-2)
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.
Inclusion: 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: 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; 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); 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; 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; HbA1c >=9.0%; Alpha-fetoprotein >=20 nanogram per milliliter (ng/mL); Phosphatidylethanol (PEth) >=80 nanogram per milliliter (ng/mL) at Screening.