Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Long-Term Efficacy and Safety of LIB003 in Patients With Cardiovascular Disease on Stable Lipid-Lowering Therapy Requiring Additional Low-Density Lipoprotein Cholesterol Reduction (LIBerate-CVD) - LIBerate-CVD

IB Therapeutics, LLC0 sites900 target enrollmentJune 23, 2021

ConditionsPatients With Cardiovascular Disease on Stable Lipid-Lowering Therapy Requiring Additional Low-Density Lipoprotein Cholesterol Reduction MedDRA version: 20.1Level: LLTClassification code 10007648Term: Cardiovascular disease, unspecifiedSystem Organ Class: 100000004849 Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Patients With Cardiovascular Disease on Stable Lipid-Lowering Therapy Requiring Additional Low-Density Lipoprotein Cholesterol Reduction
Sponsor: IB Therapeutics, LLC
Enrollment: 900
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

June 23, 2021

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

IB Therapeutics, LLC

Eligibility Criteria

Inclusion Criteria

•1\. Provision of written and signed informed consent prior to any study\-specific procedure;
•2\. Male or female, \=18 years of age at the first Screening Visit;
•3\. Weight of \=40 kg (88 lb) and body mass index (BMI) \=17 and \=42 kg/m2;
•4\. At very\-high risk for CVD, which includes history of stable CVD, defined as previous myocardial infarction (MI) (ST\-elevation MI or non\-ST\-elevation MI), angioplasty, documented coronary artery disease (stress echo, computed tomography \[CT], coronary angiography, or invasive angiography) or cerebrovascular or peripheral arterial disease without a recent event (eg, acute coronary syndrome, unstable angina, coronary artery bypass grafting, percutaneous coronary intervention, stroke, MI, carotid endarterectomy) within 3 months prior to screening;
•5\. At the defined eligibility visit (screening or post washout/stabilization), a calculated LDL\-C (by Friedewald formula) \=70 mg/dL and TG \=400 mg/dL while on stable lipid\-lowering oral drug therapy (ie, maximally tolerated statin with or without ezetimibe);
•o Note: Patients unable to tolerate approved doses of a statin may take lower than approved doses and less frequently than daily as long as the dose and dosing frequency are consistent.
•o Note: Patients with documentation of inability to tolerate any statin at any dose, or history of rhabdomyolysis, and unable to tolerate any other allowed oral lipid\-lowering agent, and thus on no lipid\-lowering therapy may also participate.
•6\. On a stable diet and lipid\-lowering oral therapy (statins, ezetimibe, bile\-acid sequestrants, OM\-3 compounds, fenofibrate, bezafibrate, nicotinic acid, and bempedoic acid) or combinations thereof, for at least 4 weeks (excluded oral lipid\-lowering agents including mipomersen, lomitapide, and gemfibrozil);
•7\. 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 a dose of 300 mg or 420 mg Q4W (\=31 days) the washout period is \=8 weeks following the last dose. For patients who have received an siRNA PCSK9 inhibitor the washout period is \=360 days post 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 Criteria

•1\. Use of prohibited oral lipid\-lowering agents, including mipomersen or lomitapide within 6 months of screening, or gemfibrozil within 6 weeks of screening;
•2\. Low\-density lipoprotein or plasma apheresis within 2 months prior to randomization;
•3\. Documented history of HoFH defined as clinical and/or genetic with true HoFH (ie, identical pathogenic variants) or compound heterozygous (ie, 2 different pathogenic LDLR variants) or combined heterozygous (2 different pathogenic FH variants such as LDLR plus apo B, or LDLR plus PCSK9 GOF) mutation;
•4\. History of any prior or active clinical condition or acute and/or unstable systemic disease compromising patient inclusion, at the discretion of the Investigator, including but not limited to clinically significant pulmonary, hematologic, gastrointestinal, endocrine (excluding diabetes), immunologic, dermatologic, neurologic, or psychiatric disease, which in the Investigator’s opinion would not be suitable for the study from a patient safety consideration or could interfere with the results of the study;
•5\. 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;
•Note: Highly effective methods of birth control include refraining from heterosexual sexual intercourse during the entire period of risk, birth control pills or patches, IUDs, sexual activity with a male partner who has had a vasectomy, condom or diaphragm or cervical cap with spermicide or IUD, oral, implantable, or injectable contraceptives.
•6\. Moderate to severe renal dysfunction, defined as an estimated glomerular filtration rate \<30 mL/min/1\.73 m2 at the Screening Visit;
•7\. Active liver disease or hepatic dysfunction (eg, cirrhosis, alcoholic liver disease, known hepatitis B \[HBV] or hepatitis C \[HCV], autoimmune hepatitis, liver failure, liver cancer), history of liver transplant, and/or AST or ALT \>2\.5 × the ULN as determined by central laboratory analysis at screening (tests that result in ALT or AST up to 3 × ULN may have 1 repeat test to confirm eligibility during the Screening Period);
•8\. Uncontrolled thyroid disease: hyperthyroidism or hypothyroidism as defined by thyroid\-stimulating hormone (TSH) below the lower limit of normal or \>1\.5 × ULN, respectively, at the Screening Visit. If TSH is above/below these cutoff points, patients can enter the study if free triiodothyronine (FT3\) is within the reference range. If controlled, treatment should be stable for at least 3 months prior to the Screening Visit;
•9\. Uncontrolled type 1 or type 2 diabetes mellitus, defined as fasting glucose \=200 mg/dL or glycated hemoglobin (HbA1c) of \>9%;