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

IB Therapeutics LLC0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年4月3日

试验速览

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•1. Provision of written and signed informed consent prior to any study-specific procedure;
•2. Weight of >=40 kg (88 lbs) and body mass index (BMI) >=17 and <=42 kg/m2;
•3. Diagnosis of definite, probable or possible HeFH based either on clinical criteria (Simon Broome register criteria or Dutch Lipid Clinics [DLC] Network Criteria) or genotyping and at the defined eligibility visit (screening or post washout/stabilization)
•4. LDL-C >=70 mg/dL (if very-high risk for CVD) or >=100 mg/dL (if high risk for CVD) and TG <=400 mg/dL while on stable lipid lowering oral drug therapy (eg, maximally tolerated statin with or without ezetimibe); 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 is consistent.
•5.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 must have an LDL-C >=190 mg/dL (4.9 mmol/L) at the Screening Visit unless they have a documented pathogenic FH variant;

•1. Use of prohibited oral lipid lowering agents mipomersen or lomitapide within 6 months of screening, gemfibrozil within 6 weeks of the Screening Visit or LDL/plasma apheresis within 2 months prior to Day 1;
•2. Documented history of HoFH defined clinically or genetically
•3. History of any prior or active clinical condition or acute and/or unstable systemic disease compromising patient inclusion, at the discretion of the Investigator.
•4.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;
•5. Moderate to severe renal dysfunction, defined as an eGFR <30 mL/min/1.73m2

发起方

IB Therapeutics LLC