Objective: Ongericimab is a human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9) and an add-on treatment to lipid-lowering therapy.1 Early clinical studies have demonstrated short-term efficacy and safety profiles, but comprehensive synthesis of available data is lacking.
Aims: To assess the efficacy and safety outcomes related to 150mg ongericimab every 2 weeks (Q2W) vs other dosing regimens every month (Q4W) or placebo, respectively, in the management of hypercholesterolemia or mixed dyslipidaemia.
Methods: We performed a meta-analysis of randomised controlled trials reporting outcomes of ongericimab use (150 mg vs. 300 mg or 450 mg; 150 mg vs placebo). PubMed, Embase, and Cochrane databases were searched up to June 2025. Outcomes included lipid parameters, injection-related and treatment-emergent adverse events (TEAE) and laboratory tests. Random-effects models were used to pool relative risk (RR) and mean difference (MD) with 95% confidence intervals using R software (version 4.4.1), following PRISMA guidelines.
Results: This meta-analysis included five studies comprising 1,400 patients. Ongericimab was associated with a favourable ≥50% LDL-C reduction (RR, 31.06 [16.27, 59.3], p<0.01). No statistical significance differences were observed for either the 450 mg (RR, 0.9 [0.77, 1.05], p=0.18) or 300 mg groups (RR, 1.08 [0.71, 1.63], P=0.73) when compared with the 150 mg group. MD between ongericimab 150mg vs 300mg groups in LDL-C, non-HDL, lipoprotein(a), apolipoprotein B from baseline to short-term follow-up were, respectively, −6.86 ([−13.95, 0.22], p=0.058); −8.18 ([−14.7, −1.66], p=0.014); −23.44 ([−45.57, −1.31], p=0.038); −7.89 ([−14.19, −1.59], p=0.014). MD between ongericimab 150 mg vs 450 mg groups in LDL-C, non-HDL, lipoprotein(a), apolipoprotein B from baseline to short-term follow-up were, respectively, 0.07 ([−23.38, 23.53], p=0.995); 4.61 ([−17.08, 26.31], p=0.677); −3.88 ([−26.09, 18.33], p=0.732); 6.9 ([−6.2, 20], p=0.302). Ongericimab was associated with an increase in injection-related events (RR, 2.5 [1.08, 5.77], p=0.03), TEAE (RR, 0.92 [0.86, 0.99], p=0.03), alanine aminotransferase >3 times ULN (RR, 2.5 [1.08, 5.77], p=0.03) compared to placebo. Creatine kinase >5 times ULN (RR, 2.13 [0.36, 12.59], p=0.40).
Conclusion: Ongericimab demonstrates efficacy and relative safety in statin-intolerant patients, though 150 mg dosing Q2W does not show better efficiency than 300 mg Q4W, only in 150 mg vs 300 mg analyses. More dose data and long-term data remain necessary to confirm short-term and sustained clinical outcomes.
