Phase 3 Study to Evaluate the Efficacy and Safety of LIB003 With Evolocumab in HoFH
Completed · Phase 3
Conditions studied: Homozygous Familial Hypercholesterolemia
In brief
To compare the safety, tolerability and LDL-C response after 24 Weeks of monthly (every 4 weeks \[Q4W\]) subcutaneous (SC) dosing of LIB003 300 mg with monthly (Q4W) SC dosing of 420 mg evolocumab (Repatha®) in patients with HoFH on stable diet and oral LDL-C-lowering drug therapy
Key facts
- Study ID
- NCT04034485
- Run by
- LIB Therapeutics LLC
- People needed
- 65
- Starts
- 2019-12-07
- Expected to finish
- 2023-01-30
- Last updated by the study team
- 2023-03-29
Who can join
Age: 10 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- HoFH diagnosed clinically and confirmed by genotyping
- Weight of >30 kg and body mass index (BMI) >17 and <40 kg/m2
- stable diet and lipid-lowering oral therapies for at least 4 weeks
You may not qualify if…
- mipomersen within 6 months of screening;
- LDL or plasma apheresis <2 months prior to randomization
- history of non-response to PCSK9 mAb or presence of receptor negative/null LDLR activity expected to result in non-response to PCSK9 inhibition
- prior or active clinical condition or acute and/or unstable systemic disease compromising subject inclusion
Where it is running
- NorthShore University Health System — Evanston, Illinois, United States
- Metabolic & Atherosclerosis Research Center (MARC) — Cincinnati, Ohio, United States
- VMMC & Safdarjung Hospital — Delhi, National Capital Territory of Delhi, India
- CIMS Hospital Pvt. Ltd — Ahmedabad, India
- G.B. Pant Institute of Postgraduate Medical Education & Research — New Delhi, India
- Department of Medicine, Hadassah University Hospital — Jerusalem, Israel
- Rabin Medical Center, Beilinson Hospital, — Petah Tikva, Israel
- Lipid Clinic, Oslo University Hospital — Oslo, Norway
- Carbohydrate and Lipid Metabolism Research Unit — Johannesburg, Gauteng, South Africa
- Division of Lipidology, Department of Medicine University of Cape Town — Cape Town, Western Province, South Africa
- Ege University Medical School — Izmir, Bornova, Turkey (Türkiye)
- Afyonkarahisar Health Sciences University — Afyonkarahisar, Turkey (Türkiye)
Full record on ClinicalTrials.gov
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