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

Completed · Phase 1 · Has a placebo group

Conditions studied: Nonalcoholic Fatty Liver

In brief

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

Key facts

Study ID

NCT03950882

Run by

Poxel SA

People needed

17

Starts

2019-08-01

Expected to finish

2020-03-31

Last updated by the study team

2021-06-11

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• High Point Clinical Trials Center — High Point, North Carolina, United States

Full record on ClinicalTrials.gov

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