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Obicetrapib for dyslipidemia with or without cardiovascular risk: A GRADE-assessed meta-analysis of randomized trials
Ahmed Emara1, Ahmed Farid Gadelmawla2, Ameer Awashra3
1Faculty of Medicine, Al-Azhar University, Cairo, Egypt.
Aims:
Obicetrapib, an oral cholesteryl ester transfer protein (CETP) inhibitor, has demonstrated potent LDL-C lowering in recent phase 2/3 trials. We evaluated Obicetrapib (1, 2.5, 5, and 10 mg) efficacy and safety in adults with dyslipidemia, with or without atherosclerotic cardiovascular disease (ASCVD) risk.
Materials And Methods:
We performed a meta-analysis of randomized controlled trials (RCTs) identified through PubMed, Cochrane, Scopus, and Web of Science up to June 2025. Dichotomous outcomes were analyzed as risk ratios (RRs) and continuous outcomes as mean differences (MDs), both with 95% confidence intervals (CIs).
Prospero Id:
CRD420251107076.
Results:
Six RCTs including 3399 patients were analysed. Compared with placebo, Obicetrapib significantly reduced LDL-C at 8-12 weeks (MD -27.66 mg/dL (-26.96%); 95% CI -33.62 to -21.70; p < 0.0001) and non-HDL-C (MD -35.41 mg/dL (-28.08%); 95% CI -39.42 to -31.39; p < 0.0001). It also increased HDL-C (MD 70.85 mg/dL (141.7%); 95% CI 62.56-79.15; p < 0.0001) and improved achievement of LDL-C targets: <55 mg/dL (RR 6.42; 95% CI 5.15-8.01), <70 mg/dL (RR 2.56; p < 0.0001), and < 100 mg/dL (RR 1.34; p < 0.0001). No significant differences were found in total adverse events (p = 0.41) or serious adverse events (p = 0.37).
Conclusion:
Obicetrapib provides substantial improvements in lipid parameters with a favourable short-term adverse events rate. These results support its role as a potential adjunctive lipid-lowering agent irrespective of ASCVD risk. Longer-term trials are warranted to confirm its durability, cardiovascular outcomes, and safety.
Insights
Obicetrapib, a cholesteryl ester transfer protein (CETP) inhibitor, significantly lowers LDL-C and non-HDL-C while increasing HDL-C. This oral medication shows a favorable short-term safety profile for dyslipidemia management.
Area of Science:
- Cardiovascular Medicine
- Pharmacology
- Lipid Metabolism
Background:
- Dyslipidemia poses a significant risk for atherosclerotic cardiovascular disease (ASCVD).
- Cholesteryl ester transfer protein (CETP) inhibitors represent a class of drugs targeting lipid metabolism.
- Obicetrapib has shown promise in lowering low-density lipoprotein cholesterol (LDL-C).
Purpose of the Study:
- To evaluate the efficacy and safety of Obicetrapib in adults with dyslipidemia.
- To assess Obicetrapib's lipid-lowering effects across various dosages (1, 2.5, 5, and 10 mg).
- To determine the drug's effectiveness in patients with and without established ASCVD risk.
Main Methods:
- A meta-analysis of six randomized controlled trials (RCTs) involving 3399 patients was conducted.
- Data were sourced from major scientific databases (PubMed, Cochrane, Scopus, Web of Science) up to June 2025.
- Dichotomous outcomes were analyzed using risk ratios (RRs) and continuous outcomes using mean differences (MDs), with 95% confidence intervals (CIs).
Main Results:
- Obicetrapib significantly reduced LDL-C by -27.66 mg/dL and non-HDL-C by -35.41 mg/dL at 8-12 weeks compared to placebo.
- The drug substantially increased high-density lipoprotein cholesterol (HDL-C) by 70.85 mg/dL.
- Obicetrapib improved achievement of LDL-C targets (<55 mg/dL, <70 mg/dL, <100 mg/dL) and demonstrated no significant difference in adverse or serious adverse events.
Conclusions:
- Obicetrapib offers significant improvements in key lipid parameters.
- The agent exhibits a favorable short-term safety profile, supporting its use as an adjunctive therapy.
- Further long-term trials are necessary to confirm cardiovascular outcomes and long-term safety.
- Obicetrapib's benefits are relevant for patients regardless of their ASCVD risk status.
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