Lerodalcibep is effective in reducing LDL-C in high-risk patients on statin therapy

Lerodalcibep, compared with placebo, led to greater reductions in low-density lipoprotein cholesterol (LDL-C) in Chinese patients with high or very high risk of atherosclerotic vascular disease who had elevated LDL-C levels despite statin therapy, according to a phase 3 trial.

Prof. Huo Yong (Peking University First Hospital, China) reported results from a phase 3, randomised, double-blind trial (NCT06568471) that assigned patients in China in a 2:1 ratio to receive lerodalcibep or placebo for 12 weeks [1]. Participants were eligible if they were at high or very high risk of atherosclerotic cardiovascular disease and required additional LDL-C lowering despite statin use. The coprimary endpoints were the percentage change in LDL-C from baseline at week 12 and the mean LDL-C at weeks 10 and 12. In total, 213 patients were randomised, of whom 96.7% completed the trial.

The trial met both coprimary endpoints. At week 12, the mean (standard error) reduction in LDL-C with lerodalcibep versus placebo was 65.9% (8.7; P<0.0001), while the placebo-adjusted mean (standard error) reduction between weeks 10 and 12 was 67.0% (8.2; P<0.0001). Additionally, ≥94% of patients receiving lerodalcibep achieved Chinese lipid management guideline targets for LDL-C at any time during the trial, compared with <5% in the placebo group. Apart from injection-site reactions (7% with lerodalcibep), treatment-emergent adverse events occurred at similar rates between groups.

Prof. Yong concluded that “lerodalcibep, a once-monthly PCSK9 inhibitor, achieved mean LDL-C reductions >65%, with >90% of patients reaching guideline targets and a favourable safety profile in Chinese patients with, or at high or very high risk of, atherosclerotic cardiovascular disease on statin therapy requiring additional LDL-C reduction.”

Chen B, et al. Efficacy and safety of lerodalcibep in Chinese patients with hypercholesterolemia: A randomized, double-blind, placebo-controlled phase 3 trial. ACC 2026, 28–30 March, New Orleans, LA, USA.