A Study to Assess the Pharmacokinetics of PXL770 After 4 Weeks of Treatment in Subjects With NAFLD

A Randomized, Double-blind, Placebo-controlled Study to Assess the Pharmacokinetics of PXL770 After 4 Weeks of Treatment in Subjects With Non-alcoholic Fatty Liver Disease (NAFLD)

This study will assess the pharmacokinetics of PXL770 after 4 weeks of treatment.

The study will be performed in subjects with Nonalcoholic Fatty Liver Disease. The primary endpoint will be the assessment of PXL770 exposure in plasma.

Inclusion Criteria:

• Subjects have given written informed consent
• Body mass index (BMI): ≥ 25 kg/m²
• Hepatic steatosis (CAP ≥ 300)
• Insulin-resistant but not diabetic subjects
• Fasting plasma glucose <126 mg/dL
• Glomerular filtration rate (eGFR) ≥ 60 mL/[min*1.73 m²]
• Alanine amino transferase (ALT) > 20 IU/L in females and > 30 IU/L in males
• Effective contraception

Exclusion Criteria:

• Evidence of another form of liver disease
• Evidence of liver cirrhosis
• Evidence of hepatic impairment
• Positive serologic evidence of current infectious liver disease
• History of excessive alcohol intake
• Acute cardiovascular disease with 24 weeks prior to screening
• Uncontrolled high blood pressure
• Any disease which in the Investigator's opinion which in the Investigator's opinion would exclude the patient from the study
• Use of non-permitted concomitant medication
• Pregnancy or lactation