Photo Credit: Nemes Laszlo
Lerodalcibep reduced low-density lipoprotein-cholesterol (LDL-C) of 50–60% at week 52 of the phase 3 LIBerate-HR trial.
Depending on the analyzed population, lerodalcibep reduced low-density lipoprotein cholesterol (LDL-C) by 50% to 60% at week 52 of the phase 3 LIBerate-HR trial. Up to 90% of participants who took lerodalcibep achieved the dual treatment target of at least a 50% decrease in LDL-C and reached the adequate LCL-C goal.
The phase 3 LIBerate-HR trial (NCT04806893) enrolled adults with high to very high cardiovascular disease risk who were not reaching their LDL-C targets on oral lipid-lowering medication.1 Researchers randomized 922 participants to the third-generation PCSK9 inhibitor lerodalcibep (300 mg every 4 weeks) or placebo. The study team analyzed efficacy endpoints in 3 population sets: per protocol (PP), modified intention-to-treat (mITT), and ITT with multiple imputation washouts, adjudicating discontinuing participants to an outcome similar to placebo.
On average, the participants were aged 65 years and about 46% were women. “The entry level of LDL cholesterol despite being on a maximum dose of statin and other oral lipid-lowering agents, was 116 mg/dL”, underlined Eric Klug, MBBCh, MMed.
The primary endpoints of percentage change at week 52 and mean of weeks 50 and 52 significantly favored the study drug in all groups. Placebo-adjusted reduction rates at week 52 were -60.27 (PP), -56.19% (mITT), and -49.67% (ITT). The means of weeks 50/52 were -65.85%, -62.69%, -55.33%, respectively. Furthermore, 90% of the active treatment cohort achieved their LDL-C goal together with a ≥50% decrease in LDL-C compared with 16% on placebo. Significant declines were also determined for other lipids like non-HDL-C and apolipoprotein B.
“Adverse events and key safety laboratory findings were similar in both arms,” noted Dr. Klug. An exception were injection site reactions with 6.9% (lerodalcibep) versus 0.3% (placebo).
“Lerodalcibep offers a novel, effective alternative to existing PCSK9 inhibitors,” Dr. Klug commented, further pointing out that its long ambient stability allowed for patient’s home use.
Medical writing support was provided by Karin Drooff, MPH.
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