LDL Cholesterol
Conditions
Keywords
low density lipoprotein cholesterol, PCSK9
Brief summary
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
Detailed 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.
Interventions
BIOLOGICALLIB003
LIB003 or placebo
Sponsors
Medpace, Inc.
LIB Therapeutics LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double-Blind and Placebo-Controlled - Study drug administered by unmasked nurse who is not involved in any other aspects of the trial
Intervention model description
Randomized, Double-Blind, Placebo-Controlled trial to evaluate LDL-C reduction with 3 different doses of LIB003 compared to placebo
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent reduction in Low Density Lipoprotein Cholesterol (LDL-C) at week 12 | baseline to 12 weeks | Change in serum LDL-C from baseline after 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The incidence and severity of treatment emergent adverse events (TEAEs) | baseline to 12 weeks | safety and tolerability will be based on the incidence and severity of treatment emergent adverse events |
| Percent reduction in apolipoprotein B (Apo B) at week 12 | baseline to 12 weeks | Change in serum Apo B from baseline after 12 weeks |
| Percent reduction in lipoprotein (a) [Lp(a)] at week 12 | baseline to 12 weeks | Change in serum Lp(a) from baseline after 12 weeks |
| Percent reduction in free PCSK9 at week 12 | baseline to 12 weeks | Change in serum free PCSK9 from baseline after 12 weeks |
| Presence of anti LIB003 antibodies (ADAs) | baseline to 12 weeks | Measurement of ADAs at baseline and various intervals |
Countries
United States
Outcome results
None listed