Study of Long-Term Efficacy and Safety of LIB003 in CVD or High Risk for CVD Patients Needing Further LDL-C Reduction (LIBerate-HR)

Phase 3

• Conditions: Health Condition 1: I251- Atherosclerotic heart disease of native coronary arteryHealth Condition 2: E780- Pure hypercholesterolemiaHealth Condition 3: E11- Type 2 diabetes mellitus

• Registration Number: CTRI/2022/01/039298
• Lead Sponsor: IB Therapeutics LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 3 April 2023

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Provision of written and signed informed consent prior to any study-specific procedure;

2.Weight of >=40 kg (88 lb) and body mass index (BMI) >=17 and <=42 kg/m2;

3.History of CVD, (including cerebrovascular or peripheral arterial disease) or very-high risk for CVD as defined in the 2019 ESC/EAS Guidelines or

4.High risk for CVD as defined in the 2019 ESC/EAS Guidelines

5.At Screening or post Washout/Stabilization, LDL-C >=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;

6.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

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 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 Criteria

1.Use of prohibited oral lipid-lowering agents mipomersen or lomitapide within 6 months of screening, gemfibrozil within 6 weeks of screening, 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;

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

6.Active liver disease or hepatic dysfunction, history of liver transplant, and/or ALT or AST >2.5 Ã? the ULN as determined by central laboratory analysis at screening

7.Uncontrolled thyroid disease: hyperthyroidism or hypothyroidism

8.Uncontrolled Type 1 or Type 2 DM, defined as FBS >=200 mg/dL or HbA1C >=9%;

9.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;

10.Planned cardiac surgery or revascularization;

11.New York Heart Association class III-IV heart failure

Study & Design

• Study Type: Interventional
• Study Design: Not specified