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<p>Most patients with heterozygous familial hypercholesterolemia fail to achieve adequate low-density lipoprotein (LDL) cholesterol lowering. Here we carried out a randomized trial to test the safety and efficacy of obicetrapib, a highly selective cholesteryl ester transfer protein inhibitor that lowers LDL cholesterol levels in patients with heterozygous familial hypercholesterolemia and an LDL cholesterol level ≥70 mg dl<sup>−1</sup> on maximally tolerated lipid-lowering therapy. The trial enrolled 354 patients (190 women, 164 men) with a mean LDL cholesterol level of 122 mg dl<sup>−1</sup> (87% on statins) who were randomized (2:1) to receive obicetrapib 10 mg or placebo daily for 365 days. For the primary endpoint, the change in LDL cholesterol from baseline to day 84, obicetrapib treatment resulted in a placebo-adjusted change in LDL cholesterol of −36.3% (95% confidence interval −42.2% to −30.4%, <i>P</i> &lt; 0.0001). In analyses of secondary endpoints at day 84, treatment with obicetrapib resulted in placebo-adjusted reductions in apolipoprotein B of −24.4%, non-HDL cholesterol of −34.5% and lipoprotein(a) of −45.9%, as well as a placebo-adjusted increase in high-density lipoprotein cholesterol of +138.7%. Obicetrapib was well tolerated. These findings suggest that obicetrapib is an effective therapy for additional lipid lowering in patients with heterozygous familial hypercholesterolemia. ClinicalTrials.gov registration: <a href="https://www.clinicaltrials.gov/study/NCT05425745">NCT05425745</a>.</p>

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Obicetrapib in patients with heterozygous familial hypercholesterolemia: the BROOKLYN randomized clinical trial

  • 期刊论文

  • 发表日期：

    2026年2月27日

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  • Stephen J. Nicholls,
  • Adam J. Nelson,
  • Marc Ditmarsch,
  • John J. P. Kastelein,
  • Christie M. Ballantyne,
  • Kausik K. Ray,
  • Ann Marie Navar,
  • Steven E. Nissen,
  • Anne C. Goldberg,
  • Liam R. Brunham,
  • Erin Wuerdeman,
  • Annie L. Neild,
  • Douglas Kling,
  • Andrew Hsieh,
  • Julie Butters,
  • Brian A. Ference,
  • Ulrich Laufs,
  • Maciej Banach,
  • Roxana Mehran,
  • Alberico L. Catapano,
  • Michael Szarek,
  • Violeta Balinskaite,
  • Michael H. Davidson

摘要

Most patients with heterozygous familial hypercholesterolemia fail to achieve adequate low-density lipoprotein (LDL) cholesterol lowering. Here we carried out a randomized trial to test the safety and efficacy of obicetrapib, a highly selective cholesteryl ester transfer protein inhibitor that lowers LDL cholesterol levels in patients with heterozygous familial hypercholesterolemia and an LDL cholesterol level ≥70 mg dl−1 on maximally tolerated lipid-lowering therapy. The trial enrolled 354 patients (190 women, 164 men) with a mean LDL cholesterol level of 122 mg dl−1 (87% on statins) who were randomized (2:1) to receive obicetrapib 10 mg or placebo daily for 365 days. For the primary endpoint, the change in LDL cholesterol from baseline to day 84, obicetrapib treatment resulted in a placebo-adjusted change in LDL cholesterol of −36.3% (95% confidence interval −42.2% to −30.4%, P < 0.0001). In analyses of secondary endpoints at day 84, treatment with obicetrapib resulted in placebo-adjusted reductions in apolipoprotein B of −24.4%, non-HDL cholesterol of −34.5% and lipoprotein(a) of −45.9%, as well as a placebo-adjusted increase in high-density lipoprotein cholesterol of +138.7%. Obicetrapib was well tolerated. These findings suggest that obicetrapib is an effective therapy for additional lipid lowering in patients with heterozygous familial hypercholesterolemia. ClinicalTrials.gov registration: NCT05425745.