In patients with heterozygous familial hypercholesterolemia (HeFH) inadequately controlled on standard lipid-lowering therapy, the novel monoclonal antibody recaticimab produced a striking reduction in LDL-C. The Phase 3 REMAIN-3 trial, published in Cardiovascular Research, demonstrated both efficacy and safety in this high-risk population.

Conducted across 25 centers in China, the multicenter, randomized, double-blind, placebo-controlled study enrolled 143 adults with genetically or clinically confirmed HeFH. Participants were randomized in a 2:1 ratio to receive subcutaneous recaticimab (150 mg) or placebo every four weeks for 12 weeks while continuing baseline lipid therapy.

At week 12, LDL-C levels fell by 54.4% in the recaticimab group compared with 4.5% in the placebo group, representing a treatment difference of nearly 50% (p < 0.0001). The antibody also improved other atherogenic lipid parameters, including non–HDL cholesterol, apolipoprotein B, and lipoprotein(a).

Treatment-related adverse events were mild and occurred at similar rates between groups (27.4% vs. 25.0%). Injection-site reactions (8.4%) and modest creatine phosphokinase increases (5.3%) were slightly more frequent with recaticimab. These findings establish recaticimab as a potent and well-tolerated lipid-lowering therapy for patients with HeFH requiring additional LDL-C reduction.