Table 3.

Ongoing phase III trials of lerodalcibep (LIB003) [69]

Trial	Description	Study population	Pts (N)	Primary endpoints	Secondary endpoints	Estimated primary completion date
LIBerate-H2H (NCT04790513)	Open-label, randomized 2:2:1 with active comparators Three arms: LIB003 300 mg monthly vs. evolocumab 420 mg monthly vs. alirocumab 300 mg monthly	Pts with CVD or a high risk of CVD based on 2019 ESC/EAS guidelines, with LDL-C ≥ 90 mg/dL while on stable diet and oral LLT	≈220	LDL-C percent change from BL to wk 12	(1) Percent of pts achieving ESC/EAS 2019 LDL-C target (2) Injection-site reactions	30 September 2021
LIBerate-FH (NCT04797104)	Double-blind, placebo-controlled, randomized 2:1 to receive LIB003 300 mg monthly or placebo	Pts with HeFH and LDL-C ≥ 70 mg/dL (if very high risk for CVD) or ≥ 100 mg/dL (if high risk for CVD) while on stable oral LLT	≈600	LDL-C percent change from BL to wk 24	(1) Incidence of AEs (2) Change in serum free PCSK9	28 February 2022
NCT04034485	Randomized, open-label, cross-over with active comparator Two arms: LIB003 300 mg monthly vs. evolocumab 420 mg monthly	Pts with verified HoFH on stable and continuing doses of oral LLT	≈70	LDL-C percent change from BL to wk 24	(1) Incidence of AEs (2) Percent change in serum Lp(a) at wk 24 (3) Change in serum apoB at wk 24 (4) Presence of anti-LIB003 antibodies	30 May 2022
LIBerate-CVD (NCT04797247)	Double-blind, placebo-controlled, randomized 2:1 to receive LIB003 300 mg monthly or placebo. Only USA involved	Pts with history of ASCVD or very high risk of ASCVD as defined in 2019 ESC/EAS guidelines with LDL-C ≥ 70 mg/dL while on stable diet and oral LLT	≈900	(1) LDL-C percent change from BL to wk 52 (2) Mean LDL-C change at wk 50 and 52	(1) Incidence of AEs (2) Free PCSK9 change (3) Percentage of pts at 2019 ESC/EAS LDL-C goals	31 October 2022
LIBerate-HR (NCT04806893)	Double-blind, placebo-controlled, randomized 2:1 to receive LIB003 300 mg monthly or placebo	Pts with history of ASCVD or very high risk of ASCVD as defined in 2019 ESC/EAS guidelines with LDL-C ≥ 70 mg/dL while on stable diet and oral LLT	≈900	(1) LDL-C percent change from BL to wk 52 (2) Mean LDL-C change at wks 50 and 52	(1) Incidence of AEs (2) Free PCSK9 change (3) Percentage of pts at 2019 ESC/EAS LDL-C goals	31 October 2022
LIBerate-OLE (NCT04798430)	Open-label extension trial	Pts who successfully completed LIB003-003, LIB003-004, LIB003-005, LIB003-006, LIB003-008, or LIB003-011	≈2000	(1) Incidence of AEs after 48 and 72 wks	(1) Incidence of antidrug antibodies 2) Percent decrease in LDL-C from BL of original study	30 December 2023

AEs adverse events, apoB apolipoprotein B, ASCVD atherosclerotic cardiovascular disease, BL baseline, CVD cardiovascular disease, EAS European Atherosclerosis Society, ESC European Society of Cardiology, HeFH heterozygous familial hypercholesterolemia, HoFH homozygous familial hypercholesterolemia, LDL-C low-density lipoprotein cholesterol, LLT lipid-lowering therapy, Lp(a) lipoprotein(a), PCSK9 proprotein convertase subtilisin-kexin type 9, pts patients, wk(s) week(s)