Status:
COMPLETED
A Study of the Efficacy and Safety of PXL770 Versus Placebo After 12 Weeks of Treatment in Patients With NAFLD
Lead Sponsor:
Poxel SA
Conditions:
Nonalcoholic Fatty Liver
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This study will assess the efficacy and safety of 3 doses of PXL770 versus placebo after 12 weeks of treatment.
Detailed Description
The study will be performed in patients with Nonalcoholic Fatty Liver Disease. The primary endpoint will be the assessment of the change in the percentage of liver fat mass (assessed by MRI-PDFF).
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 29 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 10 2020
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT03763877
Start Date
March 29 2019
End Date
August 10 2020
Last Update
October 28 2021
Active Locations (15)
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1
Study Site 02
Los Angeles, California, United States, 90057
2
Study Site 01
Gainesville, Florida, United States, 32610
3
Study Site 11
Ocoee, Florida, United States, 34761
4
Study Site 15
Orlando, Florida, United States, 32804