Efficacy and Safety of Ongericimab in Patients With Dyslipidemia: A Systematic Review and Meta-Analysis of Randomized Controlled Trials With GRADE Assessment

Dyslipidemia is a major modifiable risk factor for atherosclerotic cardiovascular disease, and many high-risk patients do not reach target low-density lipoprotein cholesterol (LDL-C) levels despite conventional therapy. Ongericimab is a humanized monoclonal antibody against proprotein convertase subtilisin/kexin type 9. We searched PubMed, Scopus, Web of Science, and Cochrane CENTRAL from inception to April 4, 2026 for randomized controlled trials comparing ongericimab with placebo in dyslipidemia, pooled data using random-effects models, and rated certainty with GRADE. Five double- blind trials (10 intervention-placebo comparisons; 1415 participants), all conducted in China, were included. Ongericimab reduced LDL-C at 12 weeks by 69.39 percentage points relative to placebo (95% confidence interval, -73.67 to -65.11), with sustained reductions at 24 weeks (-68.19; -73.67 to -62.71) and 52 weeks (-68.99; -78.33 to -59.65). At 12 weeks, it also reduced apolipoprotein B (-60.68), non-high-density lipoprotein cholesterol (-66.30), total cholesterol (-46.49), lipoprotein(a) (-45.74), and triglycerides (-25.89), and increased apolipoprotein A1 (8.15) and high-density lipoprotein cholesterol (10.33) (all P < 0.0001). Treatment-emergent adverse events (risk ratio 1.01; 0.90-1.14), serious adverse events (1.52; 0.30-7.58), injection-related adverse events (1.31; 0.45-3.78), and laboratory abnormalities did not differ from placebo.