Open-Label Extension to Evaluate the Longer Term Efficacy and Safety of LIB003
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
1 other identifier
interventional
32
1 country
3
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Feb 2019
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 14, 2019
CompletedStudy Start
First participant enrolled
February 14, 2019
CompletedFirst Posted
Study publicly available on registry
February 20, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 7, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2020
CompletedResults Posted
Study results publicly available
February 10, 2022
CompletedMarch 2, 2022
February 1, 2022
1.1 years
February 14, 2019
January 17, 2022
February 9, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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
52 weeks
Secondary Outcomes (1)
Percent Change in LDL-C at 52 Weeks
52 weeks
Study Arms (1)
LIB003
EXPERIMENTALLIB003
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Sterling Research Group
Cincinnati, Ohio, 45219, United States
The Lindner Research Center
Cincinnati, Ohio, 45219, United States
Metabolic & Atherosclerosis Research Center (MARC)
Cincinnati, Ohio, 45227, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Evan A Stein MD PhD FACC
- Organization
- LIB Therapeutics
Study Officials
- STUDY DIRECTOR
Evan A Stein, MD PhD
LIB Therapeutics
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 14, 2019
First Posted
February 20, 2019
Study Start
February 14, 2019
Primary Completion
April 7, 2020
Study Completion
August 31, 2020
Last Updated
March 2, 2022
Results First Posted
February 10, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share