Study of PXL065 in Patients With Nonalcoholic Steatohepatitis (NASH)

• Status: Active, not recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will assess the effect of 3 doses of PXL065 versus placebo on liver fat content in NASH patients after 36 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) ≤ 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) ≥ 45 mL/min/1.73m²

• Liver fat content ≥ 8% on MRI-PDFF

• Qualifying liver biopsy (NAS) ≥ 4 and fibrosis score F1, F2 or F3

• 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 within 6 months prior to Randomization

• 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