A study to Assess the Effect of Vonafexor on Kidney Function in Subjects With Impaired Renal Function and Suspected MASH - EYP001-210

ENYO Pharma0 个研究点目标入组 50 人开始时间: 2023年12月18日最近更新: 2024年7月22日

适应症

试验速览

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•Male or female subject., Age between 18 and 75 years, both inclusive., Overweight or obesity (body mass index BMI = 25.0 kg/m2 and = 45.0 kg/m2) with or without type 2 diabetes mellitus (T2DM with an HbA1c = 9.5%)., eGFR = 30 and < 90 (mL/min/1.73 m²)., Presumed mild to higher liver fibrosis as shown by a FIBROTEST score = 0.28 and/or FIB-4 score = 1.3.

•Known or suspected hypersensitivity to IMP or any of the excipients or to any component of the IMP formulation., History of multiple and/or severe allergies to drugs including contrast media or foods or a history of severe anaphylactic reaction., Known non-MASH liver disease., History or presence of cirrhosis., Proteinuria in the nephrotic range with a protein-to-creatinine ratio > 3.5 g protein/g creatinine (350 mg/mmol).

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