Open-Label Extension to Evaluate the Longer Term Efficacy and Safety of LIB003
Completed · Phase 2
Conditions studied: Hypercholesterolemia
In brief
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)
Key facts
- Study ID
- NCT03847974
- Run by
- LIB Therapeutics LLC
- People needed
- 32
- Starts
- 2019-02-14
- Expected to finish
- 2020-08-31
- Last updated by the study team
- 2022-03-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Sterling Research Group — Cincinnati, Ohio, United States
- The Lindner Research Center — Cincinnati, Ohio, United States
- Metabolic & Atherosclerosis Research Center (MARC) — Cincinnati, Ohio, United States
Full record on ClinicalTrials.gov
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