Prevention & lipidsRandomised controlled trial
Long-term efficacy and safety of lerodalcibep in heterozygous familial hypercholesterolaemia: the LIBerate-HeFH trial
- Randomised controlled trial
- placebo-controlled
- global Phase 3
- 2:1 randomisation
Authors' conclusion
Lerodalcibep, a novel anti-proprotein convertase subtilisin/kexin type 9 gene small binding protein dosed monthly as an alternative to monoclonal antibodies, significantly reduced LDL-C in subjects with heterozygous familial hypercholesterolaemia with a safety profile similar to placebo.
Study context
- Population
- Patients with heterozygous familial hypercholesterolaemia requiring additional low-density lipoprotein cholesterol (LDL-C) lowering
- Participants
- 478 patients
- Comparison
- Lerodalcibep vs placebo
- Primary endpoint
- % change from baseline in LDL-C at Week 24 and at the mean of Weeks 22 and 24
- Follow-up
- Week 24; mean of Weeks 22 and 24
Primary result
As reported in the abstract
LDL-C reduction vs placebo
- Week 24; SE 0.11; reduction
- LS mean absolute difference 2.08 mmol/L (95% CI −2.30 to −1.87); P < 0.0001
- Week 24; SE 3.25
- percentage difference −58.61 %; P < 0.0001
- mean of Weeks 22 and 24; SE 0.10; reduction
- absolute difference 2.28 mmol/L (95% CI −2.47 to −2.09); P < 0.0001
- mean of Weeks 22 and 24; SE 2.87
- percentage difference −65.0 %; P < 0.0001
Further findings
| Outcome | Lerodalcibep | Placebo |
|---|---|---|
| LDL-C reduction ≥50% and ESC LDL-C targets achieved · during the study | 68% | Not reported in the abstract |
Safety
Treatment-emergent adverse events
- Similar between lerodalcibep and placebo, except mild injection site reactions
Original publication
Long-term efficacy and safety of lerodalcibep in heterozygous familial hypercholesterolaemia: the LIBerate-HeFH trial. Eur Heart J. Published 28 August 2023. doi:10.1093/eurheartj/ehad596
Summarised from the published abstract; every number is checked against it