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Kowdley",{"type":608,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100609946","phase-3-a-clinical-study-to-investigate-the-safety-and-tolerability-of-efimosfermin-alfa-injection-in-participants-with-known-or-suspected-f2--or-f3-stage-mash-100609946",false,"NCT07221188","A Clinical Study to Investigate the Safety and Tolerability of Efimosfermin Alfa Injection in Participants With Known or Suspected F2- or F3-stage MASH","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)","ZENITH-2","Inclusion Criteria:\n\n* Able and willing to understand and sign a written informed consent form (ICF) that must be obtained prior to the initiation of study procedures\n* Age \\>=18 through \\\u003C=75 years at enrolment\n* History or presence of 2 or more of the 5 components of metabolic syndrome per American Heart Association definition\n* History or presence of known or suspected MASH with evidence of fibrosis\n\nExclusion Criteria:\n\n* ALT or AST \\>=5 × upper limit of normal (ULN)\n* Total bilirubin (BILI) \\>=1.3 milligram per deciliter (mg\u002FdL). Individuals with documented Gilbert's syndrome may be enrolled if they experienced an isolated increase in total BILI of \\>=1.3 mg\u002FdL and direct BILI is \\\u003C=20% of total BILI; otherwise, the individual will be excluded.\n* Serum albumin \\\u003C=3.5 grams per deciliter (g\u002FdL)\n* 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.\n* Alkaline phosphatase (ALP) \\>=2 × ULN\n* Platelet (PLT) count \\\u003C140 000 per (\u002F) cubic millimeter (mm\\^3); individuals with a PLT count between 110,000\u002Fmm\\^3 and 140,000\u002Fmm\\^3 may be enrolled after discussion with the Study Medical Monitor\n* Serum creatinine \\>=1.5 mg\u002FdL or creatinine clearance \\\u003C=60 milliliter (mL)\u002Fminute (min)\u002F1.73 square meter by Chronic Kidney Disease Epidemiology Collaboration equation.\n* Alpha-fetoprotein \\>=20 nanogram per milliliter (ng\u002FmL)\n* HbA1c \\>=9.0%\n* 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)\n* Phosphatidylethanol (PEth) \\>=80 nanogram per milliliter (ng\u002FmL) at Screening\n* 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.\n* 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.\n* Current or history of excessive alcohol intake for \\>=3 months within the 12-month period prior to Screening","ALL","18 Years","75 Years",{"count":621,"type":622},1250,"ESTIMATED","INTERVENTIONAL",[625],"PHASE3","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.",[628],"Non-alcoholic Fatty Liver Disease",[630,631,632,633,634,615],"Metabolic Dysfunction-Associated Steatohepatitis","efimosfermin alfa","Safety","Tolerability","Phase 3","2026-04-13",{"date":637,"type":638},"2026-04-16","ACTUAL",{"date":640,"type":638},"2025-12-12",{"date":642,"type":622},"2028-03-24",{"name":5,"class":6},43]