Obicetrapib promising add on treatment for high risk ASCVD patients on statin therapy: ROSE trial
UK: The addition of obicetrapib 5 and 10 mg to high intensity statin therapy reduces median LDL-c levels from baseline by 42% and 51%, respectively in patients enrolled in the ROSE trial. Also, obicetrpib was well-tolerated. The findings of the study were presented at the European Atherosclerosis Society (EAS) Congress 2022.
This indicates that obicetrapib can be a valuable addition for patients with higher risk for atherosclerotic cardiovascular disease (ASCVD) who did not achieve their target LDL-c goals despite high intensity statin therapy.
Previous research has show that monotherapy of CETP inhibitor obicetrapib or in combination with low statin therapy reduces LDL-c by 45%. Recently, evidence has emerged resulting in increased interest in the potential of inhibiting CETP for CV protection.
ROSE study was conducted with an aim to evaluate the lipid-lowering efficacy, safety and tolerability of obicetrapib 5 and 10 mg in patients treated with high-intensity statin therapy versus placebo.
The study included 120 patients on a stable high intensity statin with fasting LDL-c levels >1.8 mmol/L. They were randomized to placebo, obicetrapib 5 mg or obicetrapib 10 mg for 8 weeks and followed for safety, efficacy and tolerability.
Percent change from baseline in LDL-c compared to the placebo group was the primary efficacy outcome. There was a pre-specified assessment of LDL-c levels by preparative ultracentrifugation or Friedewald calculation.
Based on the study, the following findings were revealed:
- When analyzing the data of LDL-c obtained by preparative ultra-centrifugation, there was a dose-dependent decrease in LDL-c by obicetrapib (42% reduction in the 5 mg group and 51% reduction in the 10 mg group).
- Looking at the LDL-c data by the Friedewald method, a similar pattern was observed (43% reduction in the 5 mg group and 46% in the 10 mg group).
- When patients were stratified by LDL-c baseline, comparable effects on LDL-c lowering by obicetrapib were observed, with a slightly higher LDL-c reduction in those with baseline LDL ≥100 mg/dL than in those <100 mg/dL.
- Waterfall plots showed that almost all patients had some degree of LDL-c lowering with obicetrapib.
- Dose-dependent lowering of ApoB (up to 30%) and non-HDL-c (up to 44%) was observed with obecitrapib.
- HDL-c was dose-dependently increased by obecitrapib (up to 165%), as was ApoA1 (up to 48%).
- There was a reduction in Lp(a) and triglyceride levels in the obecitrapib groups.
- Addition of obecitrapib to high-intensity statin resulted in a greater proportion of patients achieving lipid goals.
- Obecitrapib was well-tolerated, and there was no increase rate of adverse events or serious adverse events.
The researchers concluded, "obicetrapib can be a valuable addition for high risk ASCVD patients who do not achieve their target LDL-c goals despite high intensity statin therapy."
Currently, obicetrapib is being evaluated in phase 3 lipid lowering and CV outcome trials.
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