Health Condition 1: E780- Pure hypercholesterolemia
Conditions
Interventions
Intervention1: LIB003: 300 mg SC Q4W ,PCSK9 inhibitor. It will be administered Q4W (every 4 weeks) as SC (subcutaneous) injections
48 weeks active treatment duration
Control Intervention1: Evolocumab
140 mg/mL solution in a single-use prefilled SureClick autoinjector (3)
It will be administered Q4W (every 4 weeks) as SC (subcutaneous) injections
Sponsors
LIB Therapeutics LLC
Eligibility
Inclusion criteria
Inclusion criteria: 1. HoFH diagnosed either clinically or genetically 2. Weight of >30 kg and body mass index (BMI) >18 and 3. stable diet and lipid-lowering oral therapies for at least 4 weeks
Exclusion criteria
Exclusion criteria: 1. mipomersen within 6 months of screening; 2. LDL or plasma apheresis 3. history of non-response to PCSK9 mAb or presence of receptor negative/null 4. 4. LDLR activity expected to result in non-response to PCSK9 inhibition 5. prior or active clinical condition or acute and/or unstable systemic disease compromising subject inclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the percent change from baseline in LDL-C level (Day 1 of Period A) at Week 24 (by Friedewald formula) of Period A or BTimepoint: day 1 of period A | — |
Secondary
| Measure | Time frame |
|---|---|
| Percent change of Period A or B from baseline (Day 1 of Period A) in: o LDL-C level at Week 24 (by Hopkins formula); o LDL-C level at Week 24 (by preparative ultracentrifugation); o LDL-C level at mean of Weeks 22 and 24 (by Friedewald formula); o LDL-C level at mean of Weeks 22 and 24 (by Hopkins formula); andTimepoint: at week24 at week 24 at weeks 22 and 24 at weeks 22 and 24 | — |
Countries
India, Israel, Norway, South Africa, Turkey, United States of America
Contacts
Public ContactAmruta Kabadi
Medpace Clinical Research India Pvt. Ltd.
Outcome results
None listed