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

LIB Therapeutics

Status and phase

Completed

Phase 2

Conditions

Hypercholesterolemia

Treatments

Drug: LIB003

Study type

Interventional

Funder types

Industry

Identifiers

NCT03847974

LIB003-010

Details and patient eligibility

About

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)

Full description

To assess the longer term safety, tolerability, immunogenicity, PK, PD and LDL C lowering efficacy after 52 weeks of additional treatment with LIB003 with subcutaneous (SC) dosing every 4 weeks (Q4W) in patients on stable maximally tolerated statins with or without ezetimibe who completed the phase 2 dose ranging trial LIB003-002

Enrollment

32 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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