Randomized, Open-Label, Phase 3 Study in which patients will receive LIB003 and Evolocumab to Evaluate the Efficacy and Safety in Homozygous Familial Hypercholesterolemia Patients on Stable Lipid-Lowering Therapy
Phase 3
- Conditions
- Health Condition 1: E780- Pure hypercholesterolemia
- Registration Number
- CTRI/2020/12/029838
- Lead Sponsor
- IB Therapeutics LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. HoFH diagnosed either clinically or genetically
2. Weight of >30 kg and body mass index (BMI) >18 and <40 kg/m2
3. stable diet and lipid-lowering oral therapies for at least 4 weeks
Exclusion Criteria
1. mipomersen within 6 months of screening;
2. LDL or plasma apheresis <2 months prior to randomization
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method