Status:
UNKNOWN
Study of Efficacy and Safety of LIB003 in Patient With CVD on Statins Requiring Additional LDL-C Reduction
Lead Sponsor:
LIB Therapeutics LLC
Collaborating Sponsors:
Medpace, Inc.
Conditions:
Cardiovascular Diseases
Hyper-LDL-cholesterolemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study is to assess LDL-C reductions at Week 52 with monthly (Q4W \[≤31 days\]) dosing of LIB003 (lerodalcibep) 300 mg administered subcutaneously (SC) compared to placebo in patients with very-hi...
Detailed Description
Randomized, double-blind, placebo-controlled, Phase 3 study of 52 weeks duration. Patients who fulfill the inclusion and exclusion criteria will be enrolled at up to 60 sites in the United States, Ca...
Eligibility Criteria
Inclusion
- Provision of written and signed informed consent prior to any study-specific procedure;
- Male or female ≥18 years of age at the first Screening Visit;
- Weight of ≥40 kg (88 lb) and body mass index (BMI) ≥17 and ≤42 kg/m2;
- At very high risk for CVD which includes history of CVD, (including cerebrovascular or peripheral arterial disease) or very high risk as defined in the 2019 ESC/EAS Guidelines
- At Screening or post Washout/Stabilization), ≥70 mg/dL and TG ≤400 mg/dL while on stable lipid-lowering oral drug therapy (i.e., maximally tolerated statin with or without ezetimibe); Patients unable to tolerate approved doses of a statin may take lower than approved doses and dose less frequently than daily as long as the dose and dosing frequency is consistent; Patients with documentation of inability to tolerate any statin at any dose, or history of rhabdomyolysis, may also participate;
- On a stable diet and lipid-lowering oral therapies (such as statins, ezetimibe, bile-acid sequestrants, OM-3 compounds, fenofibrate, bezafibrate, nicotinic acid, and bempedoic acid) or combinations thereof for at least 4 weeks
- Patients on a PCSK9 mAb at a dose of 75 mg, 140 mg, or 150 mg Q2W must undergo a washout period of ≥4 weeks after the last dose; for those on 300 mg or 420 mg Q4W (≤31 days) the washout period is ≥8 weeks following last dose; 8. Females of childbearing potential must be using a highly effective form of birth control if sexually active and have a negative urine pregnancy test at the last Screening Visit;
Exclusion
- Use of prohibited oral lipid-lowering agents mipomersen or lomitapide within 6 months of screening, gemfibrozil within 6 weeks of screening, LDL or plasma apheresis within 2 months prior to randomization; received other investigational agent(s) such as PCSK9 or Lp(a) siRNA or locked nucleic acid-reducing agents within 12 months of the Screening Visit;
- Documented history of HoFH defined clinically or genetically
- History of any prior or active clinical condition or acute and/or unstable systemic disease compromising patient inclusion, at the discretion of the Investigator
- Females of childbearing potential who are sexually active, not using or unwilling to use a highly effective form of contraception, pregnant or breastfeeding, or who have a positive urine pregnancy test at the last Screening Visit;
- Moderate to severe renal dysfunction, defined as an eGFR \<30 mL/min/1.73m2
- Active liver disease or hepatic dysfunction, history of liver transplant, and/or ALT or AST \>2.5 × the ULN as determined by central laboratory analysis at screening
- Uncontrolled thyroid disease: hyperthyroidism or hypothyroidism 9. Uncontrolled Type 1 or Type 2 DM, defined as FBS ≥200 mg/dL or HbA1C ≥9%; 10. Uncontrolled serious cardiac arrhythmia, MI, unstable angina, PCI, CABG, placement of implantable cardioverter defibrillator or biventricular pacemaker, aortic valve surgery, or stroke within 3 months prior to the Screening Visit; 11. Planned cardiac surgery or revascularization; 12. New York Heart Association class III-IV heart failure
Key Trial Info
Start Date :
April 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2024
Estimated Enrollment :
900 Patients enrolled
Trial Details
Trial ID
NCT04797247
Start Date
April 22 2021
End Date
February 28 2024
Last Update
December 11 2023
Active Locations (3)
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1
Sterling Research Group
Cincinnati, Ohio, United States, 45219
2
The Lindner Research Center
Cincinnati, Ohio, United States, 45219
3
Metabolic & Atherosclerosis Research Center (MARC)
Cincinnati, Ohio, United States, 45227