Health Condition 1: E785- Hyperlipidemia, unspecified
Conditions
Interventions
Intervention1: LIB003: Study drug (LIB003 or placebo) will be administered by SC injection in either the abdomen, thigh
or upper arm (which may be rotated) on Day 1 and Weeks 4, 8, 12, 16, and 20
Cont
Sponsors
LIB Therapeutics LLC
Eligibility
Inclusion criteria
Inclusion criteria: 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 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 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;
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline compared to placebo in LDL-C levelTimepoint: 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of Treatment-Emergent Adverse Events as assessed by Medical Dictionary for Regulatory Activities Incidence of Treatment-Emergent Adverse Events (TEAE) as assessed by Medical Dictionary for Regulatory Activities as mild, moderate or severe compared to placebo Change in serum free PCSK9 with LIB003 compared to placebo Change in percent LS mean between LIB003 and placeboTimepoint: 24 weeks | — |
Countries
Canada, France, India, Israel, New Zealand, Norway, South Africa, Spain, Turkey, United States of America
Contacts
Public ContactVignesh Kotian
Medpace Clinical Research India Pvt. Ltd.
Outcome results
None listed