Study of Efficacy and Safety of LIB003 in Patient With CVD on Statins Requiring Additional LDL-C Reduction (LIBerate-CVD)
- 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/2022/01/039661
- Lead Sponsor
- IB Therapeutics LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
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 CVD, (including cerebrovascular or peripheral arterial disease) or very high risk as defined in the 2019 ESC/EAS Guidelines
5. 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;
6. 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
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;
1. 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;
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 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method DL-C change compared to placebo <br/ ><br>Timepoint: Week 52 <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1. Incidence of Treatment-Emergent Adverse Events as assessed by Medical Dictionary for Regulatory Activities as severe, moderate or mild after 52 weeks <br/ ><br>2. Percent change in LS mean from baseline compared to placebo in free PCSK9 <br/ ><br>3. To assess the effects of LIB003 on the percentage of patients achieving an LDL-C 40 mg/dL, 55 mg/dL, 70 mg/dL, and 100 mg/dL <br/ ><br>Timepoint: 1. Week 52 <br/ ><br>2. Week 52 <br/ ><br>3. Week 52 <br/ ><br>