drugset / Trial / NCT05425745
Evaluate the Effect of Obicetrapib in Patients With HeFH on Top of Maximum Tolerated Lipid-Modifying Therapies.
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This study will be a placebo-controlled, double-blind, randomized, phase 3 study to Evaluate the Efficacy, Safety, and Tolerability of Obicetrapib in Participants with a History of Heterozygous Familial Hypercholesterolemia (HeFH).
Timeline
- Start
- 2022-07-25
- Primary completion
- 2024-05-28
- Completion
- 2024-05-28
Outcome
Met primary endpoint
registry analysis (superiority test); Placebo vs Obicetrapib 10 mg; p <.0001; Least Squares (LS) Means -36.31 (95% CI -42.22 to -30.39); ANCOVA NCT05425745 ↗
release “The BROOKLYN trial met its primary endpoint, achieving a LS mean reduction of 36.3% (p < 0.0001) compared to placebo at week 12” menarini.com ↗
Publications
- Nicholls SJ, Nelson AJ, Ditmarsch M, Kastelein JJP, Ballantyne CM, Ray KK, Navar AM, Nissen SE, Goldberg AC, Brunham LR, Wuerdeman E, Neild AL, Kling D, Hsieh A, Butters J, Ference BA, Laufs U, Banach M, Mehran R, Catapano AL, Szarek M, Balinskaite V, Davidson MH. Obicetrapib in patients with heterozygous familial hypercholesterolemia: the BROOKLYN randomized clinical trial. Nat Med. 2026 Mar;32(3):1052-1060. doi: 10.1038/s41591-025-04179-4. Epub 2026 Feb 27.
- Nicholls SJ, Nelson AJ, Ditmarsch M, Kastelein JJP, Ballantyne CM, Ray KK, Navar AM, Nissen SE, Goldberg AC, Brunham LR, Curcio D, Wuerdeman E, Neild A, Kling D, Hsieh A, Dicklin MR, Ference BA, Laufs U, Banach M, Mehran R, Catapano AL, Davidson MH. Obicetrapib on top of maximally tolerated lipid-modifying therapies in participants with or at high risk for atherosclerotic cardiovascular disease: rationale and designs of BROADWAY and BROOKLYN. Am Heart J. 2024 Aug;274:32-45. doi: 10.1016/j.ahj.2024.05.002. Epub 2024 May 4.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Obicetrapib | Small molecule | 10 mg | Oral |