Back to resultsOpen-Label Extension to Evaluate the Longer Term Efficacy and Safety of LIB003
Primary Purpose
Hypercholesterolemia
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
LIB003
Sponsored by
About this trial
This is an interventional treatment trial for Hypercholesterolemia
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
Sites / Locations
- Sterling Research Group
- The Lindner Research Center
- Metabolic & Atherosclerosis Research Center (MARC)
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
LIB003
Arm Description
LIB003
Outcomes
Primary Outcome Measures
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
safety and tolerability will be based on the incidence and severity of treatment emergent adverse events
Secondary Outcome Measures
Percent Change in LDL-C at 52 Weeks
percent change in serum LDL-C from baseline at 52 weeks
Full Information
NCT ID
NCT03847974
First Posted
February 14, 2019
Last Updated
February 9, 2022
Sponsor
LIB Therapeutics LLC
1. Study Identification
Unique Protocol Identification Number
NCT03847974
Brief Title
Open-Label Extension to Evaluate the Longer Term Efficacy and Safety of LIB003
Official Title
Open-Label Extension, Phase 2b Study to Evaluate the Longer Term Efficacy and Safety of LIB003 in Patients on Stable Lipid Lowering Therapy Requiring Additional LDL-C Reduction
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
February 14, 2019 (Actual)
Primary Completion Date
April 7, 2020 (Actual)
Study Completion Date
August 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LIB Therapeutics LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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)
Detailed 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
open-label
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LIB003
Arm Type
Experimental
Arm Description
LIB003
Intervention Type
Drug
Intervention Name(s)
LIB003
Other Intervention Name(s)
lerodalcibep
Intervention Description
300 mg SC Q4W
Primary Outcome Measure Information:
Title
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Description
safety and tolerability will be based on the incidence and severity of treatment emergent adverse events
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
Percent Change in LDL-C at 52 Weeks
Description
percent change in serum LDL-C from baseline at 52 weeks
Time Frame
52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evan A Stein, MD PhD
Organizational Affiliation
LIB Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Sterling Research Group
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
The Lindner Research Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Metabolic & Atherosclerosis Research Center (MARC)
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45227
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Open-Label Extension to Evaluate the Longer Term Efficacy and Safety of LIB003
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