Study of Obicetrapib & Ezetimibe Fixed Dose Combination on Top of Maximum Tolerated Lipid-Modifying Therapies

Summary

The study is a placebo-controlled, double-blind, randomized, phase 3 study in participants with heterozygous familial hypercholesterolemia (HeFH) and/or atherosclerotic cardiovascular disease (ASCVD) or multiple ASCVD risk factors to evaluate the efficacy, safety and tolerability of obicetrapib 10mg and ezetimibe 10mg fixed dose combination as an adjunct to diet and maximally tolerated lipid-lowering therapy.

Timeline

Start

2024-03-01

Primary completion

2024-09-25

Completion

2024-10-16

Outcome

Met primary endpoint

registry analysis (superiority test); Fixed Dose Combination vs Placebo; p <.0001; Least Squares (LS) Means -48.61 (95% CI -58.33 to -38.89); ANCOVA NCT06005597 ↗

registry analysis (superiority test); Fixed Dose Combination vs Monotherapy Ezetimibe; p <.0001; Least Squares (LS) Means -27.94 (95% CI -37.53 to -18.35); ANCOVA NCT06005597 ↗

registry analysis (superiority test); Fixed Dose Combination vs Monotherapy Obicetrapib; p = 0.0007; Least Squares (LS) Means -16.76 (95% CI -26.40 to -7.12); ANCOVA NCT06005597 ↗

registry analysis (superiority test); Monotherapy Obicetrapib vs Placebo; p <.0001; Least Squares (LS) Means -31.85 (95% CI -41.64 to -22.07); ANCOVA NCT06005597 ↗

Publications

• Results Sarraju A, Brennan D, Hayden K, Stronczek A, Goldberg AC, Michos ED, McGuire DK, Mason D, Tercek G, Nicholls SJ, Kling D, Neild AL, Kastelein J, Davidson M, Ditmarsch M, Nissen SE. Fixed-dose combination of obicetrapib and ezetimibe for LDL cholesterol reduction (TANDEM): a phase 3, randomised, double-blind, placebo-controlled trial. Lancet. 2025 May 17;405(10491):1757-1768. doi: 10.1016/S0140-6736(25)00721-4. Epub 2025 May 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Ezetimibe	Unknown	10 mg	Oral
Subject	Obicetrapib	Small molecule	10 mg	Oral

Indications