Trials / Completed
CompletedNCT04321343
Study of PXL065 in Patients With Nonalcoholic Steatohepatitis (NASH)
A 36-week, Randomized, Double-blind, Placebo-controlled, Parallel Group Trial to Assess the Efficacy and Safety of PXL065 Versus Placebo in Noncirrhotic Biopsy-proven NonAlcoholic SteatoHepatitis (NASH) Patients
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 117 (actual)
- Sponsor
- Poxel SA · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PXL065 | PXL065 oral tablet |
| DRUG | Placebo oral tablet | Placebo oral tablet |
Timeline
- Start date
- 2020-09-01
- Primary completion
- 2022-06-08
- Completion
- 2022-06-20
- First posted
- 2020-03-25
- Last updated
- 2023-08-29
- Results posted
- 2023-08-29
Locations
29 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04321343. Inclusion in this directory is not an endorsement.