Phase 2 Completed N=32 Treatment

Open-Label Extension to Evaluate the Longer Term Efficacy and Safety of LIB003

Hypercholesterolemia

Source: ClinicalTrials.gov NCT03847974 ↗

Enrolled (actual)

Serious AEs

9.4%

Results posted

Feb 2022

Primary outcomePrimary: Number of Participants With Treatment Emergent Adverse Events (TEAEs) — 3; 5 Participants

Summary

To assess the longer term safety, tolerability, and LDL C lowering efficacy after 52 weeks of additional treatment with LIB003 with subcutaneous (SC) dosing every 4 weeks (Q4W)

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Treatment Emergent Adverse Events (TEAEs)	3; 5	—
SECONDARY Percent Change in LDL-C at 52 Weeks	64.1	—

Eligibility Criteria

Inclusion Criteria

men and women 18 years or older
Elevated LDL-C on current lipid lowering therapy and; prior atherosclerotic cardiovascular disease (CVD) event or evidence of CVD or without CVD but at high risk for CVD based on American Heart Association/American College of Cardiology (AHA/ACC) CVD risk calculator, or aged 40 years and older with diabetes and moderate- to high-intensity statin, or pre-treatment LDL-C 190 mg/dL or greater or heterozygous familial hypercholesterolemia (HeFH)
patients who met original entry criteria in, and completed, the double-blind, placebo-controlled 16-week Phase 2 study (LIB003-002)

Exclusion Criteria

patients who did not who complete the double-blind, placebo-controlled 16-week Phase 2 study (LIB003-002)
<18 years of age
pregnant or women of childbearing potential not using acceptable birth control

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03847974). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.