Status:
COMPLETED
Study of PXL065 in Patients With Nonalcoholic Steatohepatitis (NASH)
Lead Sponsor:
Poxel SA
Conditions:
NASH - Nonalcoholic Steatohepatitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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
Detailed Description
The study will be performed in patients with NASH. The primary endpoint will be the assessment of the change in the percentage of liver fat content (assessed by MRI-PDFF).
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 20 2022
Estimated Enrollment :
117 Patients enrolled
Trial Details
Trial ID
NCT04321343
Start Date
September 1 2020
End Date
June 20 2022
Last Update
August 29 2023
Active Locations (29)
Enter a location and click search to find clinical trials sorted by distance.
1
Study site 11
Chandler, Arizona, United States, 85224
2
Study site 12
Glendale, Arizona, United States, 85306
3
Study site 13
Tucson, Arizona, United States, 85712
4
Study site 21
Tucson, Arizona, United States, 85712