A Confirmatory Trial of ETC-1002 in Patients With Hyper-LDL Cholesterolemia
Summary
The purpose of this study is to confirm the superiority of ETC-1002 after 12 weeks of administration at 180 mg/day to placebo in patients with hyper-LDL cholesterolemia who have inadequate control of low-density lipoprotein cholesterol (LDL C).
Timeline
- Start
- 2023-02-13
- Primary completion
- 2024-02-20
- Completion
- 2024-03-12
Outcome
Met primary endpoint
registry LEAST_SQUARES_MEAN ETC-1002 180 mg: -25.25 (Standard Error 1.864) Percent Change LEAST_SQUARES_MEAN Placebo: -3.46 (Standard Error 1.901) Percent Change NCT05683340 ↗
registry analysis (superiority test); ETC-1002 180 mg vs Placebo; p = 0.001; Least squares mean difference -21.78 (95% CI -26.71 to -16.85); MMRM NCT05683340 ↗
release “Otsuka Pharmaceutical Co., Ltd (Otsuka) announces that the primary endpoint was achieved in the Phase 3 trial in Japan of bempedoic acid” otsuka.co.jp ↗
release “primary endpoint was achieved in the Phase 3 trial in Japan for bempedoic acid” esperion.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bempedoic acid | Small molecule | 180 mg | — |