Study of PXL065 in Patients With Nonalcoholic Steatohepatitis (NASH)
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
Timeline
- Start
- 2020-09-01
- Primary completion
- 2022-06-08
- Completion
- 2022-06-20
Outcome
Met primary endpoint
registry analysis (superiority test); PXL065 7.5 mg QD vs Placebo; p = 0.0083; Mean Difference (Final Values) -25.313 (95% CI -44.1036 to -6.5227) NCT04321343 ↗
registry analysis (superiority test); PXL065 15 mg QD vs Placebo; p = 0.0237; Mean Difference (Final Values) -21.003 (95% CI -39.2074 to -2.7991) NCT04321343 ↗
registry analysis (superiority test); PXL065 22.5 mg QD vs Placebo; p = 0.0087; Mean Difference (Final Values) -23.748 (95% CI -41.4923 to -6.0035) NCT04321343 ↗
release “For the treatment of NASH, PXL065 (deuterium-stabilized R-pioglitazone) met its primary endpoint in a streamlined Phase 2 trial (DESTINY-1).” sumitomo-pharma.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PXL065 | Unknown | — | Oral |