Abstract 23082: Gemcabene Add-On Therapy to High- and Moderate-Intensity Statin Stratums in Hypercholesterolemic Subjects (ROYAL-1, a Phase 2b Study)

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Introduction: Recent large cardiovascular event outcome trials with ezetimibe and a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor added to statins demonstrated benefit from additional LDL-C reduction. Despite availability of approved injectable PCSK9 inhibitors, there still remains a need for novel, efficacious, safe, well-tolerated, and cost-effective oral LDL-C lowering therapies. Gemcabene (GEM) has been shown to significantly lower LDL-C, non-HDL-C, ApoB, and hsCRP further in hypercholesterolemic subjects when added to background statin therapy. GEM neither interacts pharmacokinetically nor has shown increased adverse effects with statins.

Hypothesis: GEM added to high- or moderate-intensity statin +/-ezetimibe therapy will provide additional LDL-C reduction for subjects not at goal.

Methods: High-risk subjects including those with heterozygous familial hypercholesterolemia or atherosclerotic cardiovascular disease on appropriate diet and stable statin therapy for at least 12 weeks and LDL-C ≥ 100 mg/dL (2.59 mmol/L) and triglycerides < 500 mg/dL (5.65 mmol/L) were randomized into a 12-week, placebo-controlled, parallel-group, double-blind study to assess the efficacy of GEM 600 mg QD on LDL-C and other lipoproteins and hsCRP. Safety and tolerability were evaluated. The subjects were stratified by high- or moderate-intensity statin therapy, with or without ezetimibe, with a target of 52 subjects (26 GEM; 26 placebo) in each stratum. The study (NCT02634151) enrolled 105 subjects (53% women, 77% Caucasian, mean age 61 years). Mean baseline LDL-C for all subjects was approximately 134 mg/dL (3.48 mmol/L) with most subjects in the high-intensity statin stratum on atorvastatin and most subjects in the moderate-intensity stratum on either simvastatin or atorvastatin.

Results: Data for the full cohort was previously reported. Data by statin-intensity stratum (high and moderate) including LDL-C, non-HDL-C, ApoB, Lp(a) and hsCRP as well as safety and tolerability will now be reported.

Conclusion: The trial and data analysis by statin-intensity stratification, including efficacy and safety, will be completed in October 2017 in time for presentation at the American Heart Association Scientific Sessions.

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