A Study of the Efficacy and Safety of PXL770 Versus Placebo After 12 Weeks of Treatment in Patients With NAFLD

• Status: Completed
• Trial end date: 2020-08-10
• Target enrollment: 0
• Participant gender: All

Summary

This study will assess the efficacy and safety of 3 doses of PXL770 versus placebo after 12 weeks of treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Poxel SA

Criteria

Inclusion Criteria:

• Patients have given written informed consent

• Body mass index (BMI) ≥ 25 to ≤ 50 kg/m²

• For patients with type 2 diabetes mellitus: either naive of glucose lowering drug or under stable oral glucose lowering drug

• Estimated glomerular filtration rate (eGFR) ≥ 60 mL/[min*1.73m²]

• Alanine amino transferase (ALT) > 20 IU/L in females and > 30 IU/L in males

• Hepatic steatosis (MRI-PDFF ≥ 10%)

• Effective contraception for women of child bearing potential

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