Obicetrapib
Rationale and design of BROADWAY and BROOKLYN: 2,886 participants randomised to test obicetrapib on top of maximally tolerated therapy (Am Heart J 2024)
Original title: 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
The design paper for BROADWAY (NCT05142722) and BROOKLYN (NCT05425745), two placebo-controlled, double-blind phase 3 trials testing obicetrapib 10 mg daily as an adjunct to dietary intervention and maximally tolerated lipid-modifying therapy, in participants with atherosclerotic cardiovascular disease or heterozygous familial hypercholesterolaemia whose LDL-C remained uncontrolled. The primary efficacy endpoint in both is percent change in LDL-C from baseline to day 84, with secondary endpoints covering apoB, non-HDL-C, HDL-C, apoA1, Lp(a) and triglycerides; BROADWAY additionally adjudicates major adverse cardiovascular events and includes glucose homeostasis and ambulatory blood pressure substudies. A total of 2,532 participants were randomised in BROADWAY and 354 in BROOKLYN, 2:1 to obicetrapib or placebo for 365 days. Results were anticipated later in 2024; this paper reports trial design only, no efficacy data.
Original abstract
Background: Obicetrapib, a novel, selective cholesteryl ester transfer protein (CETP) inhibitor, reduces low-density lipoprotein cholesterol (LDL-C), LDL particles, apolipoprotein (Apo) B, and lipoprotein(a) [Lp(a)] and increases high-density lipoprotein cholesterol (HDL-C) when added to statins with or without ezetimibe. By substantially reducing LDL-C, obicetrapib has the potential to lower atherogenic lipoproteins in patients with atherosclerotic cardiovascular disease (ASCVD) or heterozygous familial hypercholesterolemia (HeFH) whose LDL-C levels remain high despite treatment with available maximally tolerated lipid-modifying therapies, addressing an unmet medical need in a patient population at high risk for cardiovascular events.
Methods And Results: BROADWAY (NCT05142722) and BROOKLYN (NCT05425745) are ongoing placebo-controlled, double-blind, randomized Phase III trials designed to examine the efficacy, safety, and tolerability of obicetrapib as an adjunct to dietary intervention and maximally tolerated lipid-modifying therapies in participants with a history of ASCVD and/or underlying HeFH whose LDL-C is not adequately controlled. The primary efficacy endpoint was the percent change in LDL-C from baseline to day 84. Other endpoints included changes in Apo B, non-HDL-C, HDL-C, Apo A1, Lp(a), and triglycerides in addition to parameters evaluating safety, tolerability, and pharmacokinetics. BROADWAY also included an adjudicated assessment of major adverse cardiovascular events, measurements of glucose homeostasis, and an ambulatory blood pressure monitoring substudy. A total of 2,532 participants were randomized in BROADWAY and 354 in BROOKLYN to receive obicetrapib 10 mg or placebo (2:1) for 365 days with follow-up through 35 days after the last dose. Results from both trials are anticipated in 2024.
Conclusion: These trials will provide safety and efficacy data to support the potential use of obicetrapib among patients with ASCVD or HeFH with elevated LDL-C for whom existing therapies are not sufficiently effective or well-tolerated.
familial hypercholesterolaemiaobicetrapiboutcomes trialsphase 3
Summary written by cetpinhibition.org from the published abstract; figures as published. Page updated 18 August 2026. Methods.