A Dose-finding Trial of ETC-1002(Bempedoic Acid) in Patients With Hypercholesterolemia
Summary
The purpose of this study is to assess the low-density lipoprotein cholesterol (LDL-C)-lowering efficacy and safety of ETC-1002(bempedoic acid) 60 mg, 120 mg and 180 mg versus placebo added to ongoing stable statin therapy or other lipid-modifying therapies in Japanese patients with hypercholesterolemia treated for 12 weeks.
Timeline
- Start
- 2021-03-24
- Primary completion
- 2022-04-18
- Completion
- 2022-05-17
Outcome
Met primary endpoint
registry LEAST_SQUARES_MEAN ETC-1002 180 mg: -21.26 (Standard Error 2.095) Percent Change; LEAST_SQUARES_MEAN Placebo: -1.92 (Standard Error 2.117) Percent Change NCT04784442 ↗
registry analysis (superiority test); ETC-1002 180 mg vs Placebo; p <0.001; Least squares mean difference -19.35 (95% CI -24.81 to -13.88); ANCOVA NCT04784442 ↗
registry analysis (superiority test); ETC-1002 120 mg vs Placebo; p <0.001; Least squares mean difference -19.93 (95% CI -25.45 to -14.41); ANCOVA NCT04784442 ↗
registry analysis (superiority test); ETC-1002 60 mg vs Placebo; p = 0.002; Least squares mean difference -8.67 (95% CI -14.22 to -3.12); ANCOVA NCT04784442 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bempedoic acid | Small molecule | 60 mg | — |
| Subject | Bempedoic acid | Small molecule | 120 mg | — |
| Subject | Bempedoic acid | Small molecule | 180 mg | — |