drugset / Trial / NCT05421078
A Dose-Finding Study in Japanese Patients to Evaluate the Effect of Obicetrapib as an Adjunct to Stable Statin Therapy.
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This study will be a placebo-controlled, double-blind, randomized, phase 2 dose-finding study in Japanese patients to evaluate the efficacy, safety, and tolerability of obicetrapib as an adjunct to stable statin therapy.
Timeline
- Start
- 2022-06-27
- Primary completion
- 2023-03-24
- Completion
- 2023-04-21
Outcome
Met primary endpoint
registry analysis (superiority test); Placebo vs 2.5 mg Obicetrapib; p <.0001; Least Squares (LS) Means -25.84 (95% CI -36.53 to -15.14); NCT05421078 ↗
registry analysis (superiority test); Placebo vs 10 mg Obicetrapib; p <.0001; Least Squares (LS) Means -36.81 (95% CI -47.83 to -25.80); ANCOVA; NCT05421078 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Obicetrapib | Small molecule | 2.5 mg | — |
| Subject | Obicetrapib | Small molecule | 5 mg | — |
| Subject | Obicetrapib | Small molecule | 10 mg | — |