DOI: 10.1161/circ.148.suppl_1.15201 ISSN: 0009-7322

Abstract 15201: Obicetrapib as an Adjunct to Stable Statin Therapy Significantly Lowers LDL-C, Non-HDL-C, and Apolipoprotein B in Japanese Patients: Results From the Japan Phase 2 Study

Mariko Harada-Shiba, Douglas Kling, John J Kastelein, Marc Ditmarsch, Erin Wuerdeman, Andrew Hsieh, Stephen Nicholls, Michael Davidson
  • Physiology (medical)
  • Cardiology and Cardiovascular Medicine

Background: Obicetrapib is a selective CETP inhibitor that has been shown to reduce LDL-C, non-HDL-C, lipoprotein particles, and apolipoproteins when used as monotherapy, and in combination with ezetimibe, on background high-intensity statins. Previous studies of obicetrapib were conducted in predominantly Caucasian participants. There is a lack of clinical experience with obicetrapib when used in combination with stable statin therapy among Asian population. Objectives: This study was designed to fill the gap in clinical experience and to characterize the safety, efficacy profile of obicetrapib within the Asian population.

Methods: The Phase 2 study is a trial of Japanese participants who had not achieved treatment goal in accordance with the 2022 Japan Atherosclerosis Society Guidelines and with LDL-C >70 mg/dL or non-HDL-C > 100 mg/dL and TG < 400 mg/dL, while receiving stable statin background therapy. Participants were randomized 1:1:1:1 to obicetrapib 2.5 mg (n=25), obicetrapib 5 mg (n=25), obicetrapib 10 mg (n=26), or placebo (n=26). The primary endpoint was percent change in LDL-C from baseline to week 8. Key secondary endpoints included changes in ApoB, non-HDL-C, and HDL-C. Standard safety assessments were conducted.

Results: Obicetrapib produced significant lowering of median LDL-C (45.8%, P<0.0001), ApoB (29.7%, P<0.0001), non-HDL-C (37.0%, P<0.0001) and raising of HDL-C (158.9%, P<0.0001). Placebo demonstrated median change of -0.9%, -0.4%, -0.4% and +5.2% for these parameters respectively. Obicetrapib was well tolerated with similar treatment emergent adverse events compared to placebo. There were no clinically significant changes in laboratory parameters, vital signs, or physical examinations in any treatment group.

Conclusions: Similar to previous studies, obicetrapib 2.5 mg, 5 mg, and 10 mg resulted in significant reductions in LDL-C, ApoB, and non-HDL-C in the Asian population. All doses of obicetrapib were safe and well tolerated.

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