Proven LDL-C reduction that helps patients maintain their target level
At 1 year, studies showed that:
of patients with or at very high risk for ASCVD achieved their study targets for both absolute and percentage reduction of LDL-C.1,2*
Clinical Trials
Adults with or at very high risk for ASCVD2
Mean change in LDL-C
from baseline
at Weeks 50/52
(P<0.0001)
Mean change in LDL-C
from baseline
at Week 52
(P<0.0001)
The co-primary endpoints were percent change from baseline in LDL-C at Week 52 and mean LDL-C at Weeks 50 and 52
Safety was generally comparable with placebo4
The most commonly occurring adverse reactions in clinical trials in primary hyperlipidemia in adults (including HeFH) ≥2% of patients treated with LEROCHOL (lerodalcibep-liga) and occurring more frequently than with placebo were nasopharyngitis (15% and 14% versus placebo), local injection site reactions (12% and 5% versus placebo), and peripheral edema (2% and <1% versus placebo).4
The most frequent adverse reaction leading to treatment discontinuation in trials in primary hypercholesterolemia in adults was injection site reactions, with a higher frequency in the LEROCHOL-treated group compared to placebo-treated patients (1% versus 0%).1
Study design: LIBerate-CVD was a phase 3, global, randomized, double-blind, placebo-controlled trial evaluating lerodalcibep in adults with established ASCVD or at very high risk for ASCVD receiving maximally tolerated lipid-lowering therapy. A total of 922 patients were randomized to lerodalcibep 300 mg subcutaneously every 4 weeks (Q4W) or placebo for 52 weeks. The co-primary endpoints were percentage change from baseline in LDL-C at Week 52 and mean LDL-C at Weeks 50 and 52.4
Adults with or at very high or high risk for ASCVD1
Mean change in LDL-C
from baseline
at Weeks 50/52
(P<0.0001)
Mean change in LDL-C
from baseline
at Week 52
(P<0.0001)
The co-primary endpoints were percent change from baseline in LDL-C at Week 52 and mean LDL-C at Weeks 50 and 52
Safety was generally comparable with placebo4
The most commonly occurring adverse reactions in clinical trials in primary hyperlipidemia in adults (including HeFH) ≥2% of patients treated with LEROCHOL (lerodalcibep-liga) and occurring more frequently than with placebo were nasopharyngitis (15% and 14% versus placebo), local injection site reactions (12% and 5% versus placebo) and peripheral edema (2% and <1% versus placebo).4
The most frequent adverse reaction leading to treatment discontinuation in trials in primary hypercholesterolemia in adults was injection site reactions, with a higher frequency in the LEROCHOL-treated group compared to placebo-treated patients (1% versus 0%).1
Study design: LIBerate-HR was a phase 3, global, randomized, double-blind, placebo-controlled trial evaluating lerodalcibep in adults with or at high or very high risk for ASCVD receiving maximally tolerated lipid-lowering therapy. A total of 922 patients were randomized to lerodalcibep 300 mg subcutaneously Q4W or placebo for 52 weeks. The co-primary endpoints were percent change from baseline in LDL-C at Week 52 and mean LDL-C at Weeks 50 and 52.1
Adults with HeFH3
HIGHLY SIGNIFICANT LDL-C REDUCTION IN ADULTS WITH HeFH3
Mean change in LDL-C
from baseline
at Weeks 22/24
(P<0.0001)
Mean change in LDL-C
from baseline
at Week 24
(P<0.0001)
The co-primary endpoints were percent change from baseline in LDL-C at Week 24 and mean LDL-C at Weeks 22 and 24
Safety was generally comparable with placebo4
The most commonly occurring adverse reactions in clinical trials in HeFH (≥2% of patients treated with LEROCHOL and occurring more frequently than with placebo) were injection site reactions (18% and 3% versus placebo), nasopharyngitis (13% and 9% versus placebo), diarrhea (3% and 1% versus placebo), nausea (2% and 0% versus placebo) and peripheral edema (2% and <1% versus placebo).4
Study design: LIBerate-HeFH was a phase 3, global, randomized, double-blind, placebo-controlled trial evaluating lerodalcibep in adults with HeFH receiving maximally tolerated lipid-lowering therapy. A total of 478 patients were randomized to lerodalcibep 300 mg subcutaneously Q4W or placebo for 24 weeks. The co-primary endpoints were percent change from baseline in LDL-C at Week 24 and mean LDL-C at Weeks 22 and 24.3
apolipoprotein B
was reduced by
Across
clinical trials:1,3,4
levels of lipoprotein(a) decreased by
~33%ASCVD, atherosclerotic cardiovascular disease; CVD, cardiovascular disease; HeFH, heterozygous familial hypercholesterolemia; LDL-C, low-density lipoprotein cholesterol; Q4W, every 4 weeks. *Treatment goals are defined based on cardiovascular risk. For very-high-risk patients, targets are a ≥50% reduction in LDL-C and an absolute level <55 mg/dL. For high‑risk patients, targets are a ≥50% reduction and <70 mg/dL.1,2
References: 1. Klug EQ, Llerena S, Burgess LJ, et al. Efficacy and safety of lerodalcibep in patients with or at high risk of cardiovascular disease: a randomized clinical trial. JAMA Cardiol. 2024;9(9):800-807. 2. Kereiakes DJ, Fourie N, Engelbrecht J, et al. Long term efficacy and safety of lerodalcibep in patients with atherosclerotic cardiovascular disease. Atherosclerosis. 2024;395(suppl 1):118465. 3. Raal F, Fourie N, Scott R, et al. Long-term efficacy and safety of lerodalcibep in heterozygous familial hypercholesterolaemia: the LIBerate-HeFH trial. Eur Heart J. 2023;44(40):4272-4280. 4. Lerochol [prescribing information]. LIB Therapeutics; 2026.