Study to Evaluate Efficacy and Safety of LIB003 in Patients on Lipid-Lowering Therapy Needing Additional LDL-C Reduction

LIB Therapeutics

Status and phase: Completed; Phase 2

Conditions: LDL Cholesterol

Treatments: Biological: LIB003

Study type: Interventional

Funder types: Industry

Identifiers

NCT03549260

LIB003-002

Details and patient eligibility

About

Study to assess the LDL-C lowering efficacy of different doses of LIB003 administered every 4 weeks in subjects on stable statin and/or ezetimibe therapy

Full description

Randomized, Double-Blind, Placebo-Controlled, Phase 2 study to assess the LDL-C lowering efficacy at Week 12 of various doses of LIB003 administered subcutaneously (SC) every 4 weeks (Q4W) in patients with hypercholesterolemia on stable diet and oral LDL-C-lowering drug therapy.

Enrollment: 81 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female, 18 years of age or older
2. Elevated LDL-C on current lipid lowering therapy and; prior atherosclerotic cardiovascular disease (ASCVD) event or evidence of ASCVD or without ASCVD but at high risk for ASCVD based on 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)
3. Body mass index (BMI) between 18 and 40 kg/m2

Exclusion criteria

1. Females of childbearing potential not using or willing to use an effective form of contraception, or pregnant or breastfeeding, or who have a positive serum pregnancy test at screening
2. Homozygous familial hypercholesterolemia
3. LDL or plasma apheresis within 2 months; lomitapide or mipomersen within 12 months
4. Uncontrolled cardiac arrhythmia, myocardial infarction, unstable angina, PCI, CABG, or stroke within 3 months prior to enrollment
5. Uncontrolled cardiac arrhythmia, myocardial infarction, unstable angina, PCI, CABG, or stroke within 3 months prior to enrollment
6. Newly diagnosed or poorly controlled (HbA1c >9%) type 2 diabetes
7. Uncontrolled hypertension
8. Moderate to severe renal insufficiency
9. Elevated liver function test at screening
10. Uncontrolled cardiac arrhythmia or prolonged QT on EKG
11. A history of prescription drug abuse, illicit drug use, or alcohol abuse

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

81 participants in 3 patient groups

LIB003 150 mg or matching placebo

Experimental group

Description:

SC LIB003 150 mg or placebo every 4 weeks

Treatment:

Biological: LIB003

LIB003 300 mg or matching placebo

Experimental group

Description:

SC LIB003 300 mg or placebo every 4 weeks

Treatment:

Biological: LIB003

LIB003 350 mg or matching placebo

Experimental group

Description:

SC LIB003 350 mg or placebo every 4 weeks

Treatment:

Biological: LIB003