Emerging Lipid-Lowering Therapies

Meta-analysis of clinical trials confirms the efficacy of recaticimab in lipid reduction

Recaticimab, compared with placebo, leads to significant improvements in low-density lipoprotein cholesterol (LDL-C) and lipoprotein(a) (Lp(a)) across populations at risk of cardiovascular disease, according to a meta-analysis of phase 3 clinical trials.

Dr Sergio Fausto Girón (Francisco Marroquín University, Guatemala) reported results from a systematic literature review and meta-analysis of phase 3 trials evaluating recaticimab versus placebo [1]. Treatment effects were assessed using random-effects models in pooled populations.

Three randomised trials were included: REMAIN-1 (NCT04849000; non-familial hypercholesterolaemia and mixed hyperlipaemia), REMAIN-2 (NCT04885218; add-on therapy to statins for non-familial hypercholesterolaemia), and REMAIN-3 (NCT04844125; heterozygous familial hypercholesterolaemia), comprising a total of 1,535 patients. Across all trials, recaticimab significantly reduced LDL-C (mean difference -54.0%; 95% CI -62.3 to -45.7) and Lp(a) levels (mean difference -35.0%; 95% CI -39.9 to -30.15).

Dr Girón concluded that, in randomised controlled clinical trials, “recaticimab achieved robust and consistent lipid lowering, with approximately 54% reduction in LDL-C and around 35% reduction in Lp(a) with once-monthly dosing, independent of background therapy. These findings were consistent across diverse populations, supporting recaticimab as a promising long-acting PCSK9 inhibitor.”

Girón SF, et al. Efficacy and safety of recaticimab for LDL-C and lipoprotein(A) reduction: A systematic review and meta-analysis. ACC 2026, 28–30 March, New Orleans, LA, USA.

May 18, 2026/by Maria Joao Pires

ACC 2026, Conference Spotlights, Emerging Lipid-Lowering Therapies

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.

May 18, 2026/by Maria Joao Pires

ACC 2026, Emerging Lipid-Lowering Therapies

Enlicitide shows sustained lipid lowering in patients with or at risk of ASCVD

Enlicitide versus placebo demonstrated significant and sustained reductions in low-density lipoprotein cholesterol (LDL-C) and other atherogenic lipids, together with high treatment adherence, according to a pooled analysis of phase 3 trials reported by Prof. Ann Marie Navar (University of Texas Southwestern Medical Center, TX, USA) [1].

CORALreef Lipids (NCT05952856) and CORALreef HeFH (NCT05952869) were similarly designed phase 3, randomised, controlled trials assigning patients in a 2:1 ratio to enlicitide or placebo for 52 weeks. Participants were eligible if they had a history of major atherosclerotic cardiovascular events with LDL-C levels ≥55 mg/dL or were at risk for such events with LDL-C levels ≥70 mg/dL. In both trials, background therapy consisted of an optimised, stable statin with or without other lipid-lowering therapies. Outcomes included changes in lipid parameters at weeks 24 and 52. The total pooled population was 3,207 patients.

At week 24, enlicitide led to a mean reduction of 60.4% in LDL-C, compared with a 3.0% increase in LDL-C in the comparator (least-squares mean between-group difference -63.6%; 95% CI -66.0% to -61.2%). These results were further maintained through week 52 in the pooled population. Significant reductions with enlicitide were also observed in non-HDL-C, apolipoprotein B (ApoB) and lipoprotein(a) (Lp(a)) at both at weeks 24 and 52. Treatment adherence, defined as following all dosing instructions with no more than 1 missed day per week, was self-reported at a rate of 98%.

“Enlicitide provided significant and sustained LDL-C lowering through week 52,” concluded Prof. Navar. “Patients who remained on treatment achieved a 64% placebo-corrected reduction at week 24 and 60% at week 52. The high degree of self-reported adherence to dosing instructions is corroborated by the sustained LDL-C lowering observed in this analysis.”

Navar AM et al. Durability of enlicitide for lipid lowering: On-treatment analysis of data from CORALreef Lipids and CORALreef HeFH trials. ACC 2026, 28–30 March, New Orleans, LA, USA.

May 18, 2026/by Maria Joao Pires

ACC 2026, Conference Spotlights, Emerging Lipid-Lowering Therapies