Trial to evaluate efficacy and safety of lerodalcibep (LIB003), evolocumab and alirocumab in patients at high risk CVD (LIBerate-H2H) (NCT04790513)

Posted on 26 July 2024 | Posted in LIB003

Study title/design	Trial to evaluate efficacy and safety of lerodalcibep (LIB003), evolocumab and alirocumab in patients at high risk CVD (LIBerate-H2H) (NCT04790513)
Trial	NCT04790513/LIB003-011 (Completed).
Aim	To compare LDL-C reductions at week 12 of monthly lerodalcibep 300 mg s.c., evolocumab 420 mg s.c., and alirocumab 300 mg s.c. in patients with cardiovascular disease (CVD) or at high risk of CVD.
Study Design	Phase 3 randomised, open label study of lerodalcibep 300 mg s.c., evolocumab 420 mg s.c. or alirocumab 300 mg s.c. every 4 weeks (Q4W) for 12 weeks.
Patient population	204 patients aged > 18 years: Diagnosed with CVD or at high risk, based on 2019 ESC/EAS guidelines. Weight > 40 kg and BMI 17-42 kg/m². LDL-C > 90 mg/dL and TG < 400 mg/dL for > 4 weeks Stable diet and high intensity statin with/without ezetimibe. No HoFH. No PCSK9 mAb within 4 weeks if previously on Q2W dosing or 8 weeks if on Q4W.
Primary efficacy endpoint	LS mean percent LDL-C change from baseline to week 12.
Other endpoints	Percent of patients reaching 2019 ESC/EAS LDL-C goals at week 12. Injection site reactions after each dose to week 12.
Key results	N/A
Author conclusion	N/A
Links	https://clinicaltrials.gov/study/NCT04790513?intr=LIB003&page=2&rank=11

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