A Phase 3 interventional study of lerodalcibep and evolocumab in Homozygous Familial Hypercholesterolemia, sponsored by LIB Therapeutics LLC. Completed at 12 sites in 6 countries. Open to participants aged 10 Years and older. Per ClinicalTrials.gov, last updated 2023-03-29.
Sponsored by LIB Therapeutics LLC · Phase 3, Interventional, and Treatment
To compare the safety, tolerability and LDL-C response after 24 Weeks of monthly (every 4 weeks [Q4W]) subcutaneous (SC) dosing of LIB003 300 mg with monthly (Q4W) SC dosing of 420 mg evolocumab (Repatha®) in patients with HoFH on stable diet and oral LDL-C-lowering drug therapy
Patients with verified HoFH on stable and continuing doses of oral lipid lowering therapy will be randomized to either evolocumab 420 mg Q4W or LIB003 300 mg Q4W for 24 weeks (Period A). At Week 24, subjects will be crossed over to LIB003 if they were on evolocumab and vice versa for the next 24 weeks (Period B).
72 studies on the registry are indexed under Homozygous Familial Hypercholesterolemia; 12 are open to participants now.
This study's enrollment of 65 is above the median of 21 across 53 interventional studies indexed under Homozygous Familial Hypercholesterolemia.
Browse Homozygous Familial Hypercholesterolemia studies →LIB Therapeutics LLC is the lead sponsor of 13 studies on the registry; 3 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 2 (25%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
300 mg SC Q4W
Drug: lerodalcibep
420 mg SC Q4W
Drug: evolocumab
PCSK9 inhibitor
Also known as: LIB003
PCSK9 inhibitor
Also known as: Repatha
Percent reduction in Low Density Lipoprotein Cholesterol (LDL-C) at week 24
Change in serum LDL-C from baseline after 24 weeks
Time frame: baseline to 24 weeks on each treatment
The incidence and severity of treatment emergent adverse events (TEAEs)
safety and tolerability will be based on the incidence and severity of treatment emergent adverse events
Time frame: baseline to 24 weeks on each treatment
Percent reduction in lipoprotein (a) [Lp(a)] at week 24
Change in serum Lp(a) from baseline after 24 weeks
Time frame: baseline to 24 weeks on each treatment
Percent reduction in apolipoprotein B (Apo B) at week 24
Change in serum Apo B from baseline after 24 weeks
Time frame: baseline to 24 weeks on each treatment
Presence of anti LIB003 antibodies (ADAs)
Measurement of ADAs at baseline and various intervals
Time frame: baseline to 24 weeks
Plan to share: No
Ran from Dec 2019 to primary completion in Sep 2022, 33 months.
Of 21 phase 3 interventional studies under Homozygous Familial Hypercholesterolemia, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 34. This study's 33 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Lerodalcibep
Homozygous Familial Hypercholesterolemia →
LIB Therapeutics LLC