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

LDL Cholesterol Clinical Trial

Official title:

Randomized, Double-Blind, Placebo-Controlled, Phase 2, Dose Finding Study to Evaluate the Efficacy and Safety of LIB003 in Patients on Stable Lipid-Lowering Therapy Requiring Additional LDL-C Reduction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03549260
• Other study ID #: LIB003-002
• Status: Completed
• Phase: Phase 2
• Start date: May 22, 2018
• Est. completion date: November 30, 2018

Study information

• Verified date: February 2019
• Source: LIB Therapeutics LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: November 30, 2018
• Est. primary completion date: November 9, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• LDL Cholesterol

Intervention

Biological:
• LIB003
LIB003 or placebo

Locations

Country	Name	City	State
United States	Metabolic & Atherosclerosis Research Center (MARC)	Cincinnati	Ohio
United States	Sterling Research Group	Cincinnati	Ohio
United States	The Lindner Research Center	Cincinnati	Ohio
United States	Midwest Institute For Clinical Research	Indianapolis	Indiana
United States	Louisville Metabolic and Atherosclerosis Research Center	Louisville	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
LIB Therapeutics LLC	Medpace, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent reduction in Low Density Lipoprotein Cholesterol (LDL-C) at week 12	Change in serum LDL-C from baseline after 12 weeks	baseline to 12 weeks
Secondary	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	baseline to 12 weeks
Secondary	Percent reduction in apolipoprotein B (Apo B) at week 12	Change in serum Apo B from baseline after 12 weeks	baseline to 12 weeks
Secondary	Percent reduction in lipoprotein (a) [Lp(a)] at week 12	Change in serum Lp(a) from baseline after 12 weeks	baseline to 12 weeks
Secondary	Percent reduction in free PCSK9 at week 12	Change in serum free PCSK9 from baseline after 12 weeks	baseline to 12 weeks
Secondary	Presence of anti LIB003 antibodies (ADAs)	Measurement of ADAs at baseline and various intervals	baseline to 12 weeks