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NCT07221227
A Pivotal Clinical Study to Investigate Efimosfermin Alfa in Participants With Biopsy-confirmed F2- or F3-stage MASH
Conditions: Non-alcoholic Fatty Liver Disease
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 1200
Sponsor: GlaxoSmithKline
Location: GSK Investigational Site Chandler Arizona
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 Criteria
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 \=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 \=2\*ULN
7. Platelet (PLT) count \=1.5 mg/dL or creatinine clearance \=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
Source: ClinicalTrials.gov (NCT07221227). StuddyBuddy aggregates publicly available trial information.