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

IB Therapeutics, LLC0 sites900 target enrollmentMay 26, 2021

ConditionsPatients With Cardiovascular Disease or at High Risk for 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 or at High Risk for 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: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

May 26, 2021

End Date

TBD

Last Updated

2 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\. Evidence of very\-high or high risk for CVD:
•o Very\-high risk for CVD including 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;
•o High risk for CVD (ASCVD risk equivalent) including type 2 diabetes mellitus, FH, untreated LDL\-C \>190 mg/dL, or a 10\-year risk of a CVE of \=10% as assessed by Risk Score for Cardiovascular Disease or equivalent;
•o Note: ASCVD encompasses acute coronary syndrome, history of MI, stable or unstable angina, coronary or other arterial revascularization, stroke, TIA, and peripheral arterial disease, including aortic aneurysm, all of atherosclerotic origin.
•o Note: Definite, probable, or possible FH by Simon Broome Register Criteria or Dutch Lipid Clinic Network Criteria
•5\. At the defined eligibility visit (screening or post washout/stabilization), a calculated LDL\-C (by Friedewald formula) \=70 mg/dL (if very\-high risk for CVD) or \=100 mg/dL (if high risk or no CVD) 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.

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 cut points, patients can enter 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 and glycated hemoglobin (HbA1c) of \>9%;