Long-term Efficacy and Safety of OLE LIB003 in HoFH, HeFH, and High-risk CVD Patients Requiring Further LDL-C Reduction
Condition(s) studied
Study summary
The study is to assess the long-term safety, tolerability, and efficacy after 48 and 72 weeks with monthly (Q4W \[\<31 days\]) dosing of subcutaneous (SC) LIB003 300 mg administered in patients with CVD or at high risk for CVD (including HoFH and HeFH) on stable diet and oral LDL-C lowering drug therapy who completed one of the LIB003 Phase 3 base studies.
Eligibility
Primary outcome measure(s)
- Incidence of Treatment-Emergent Adverse Events as assessed by Medical Dictionary for Regulatory Activities as severe, moderate or mild after 48 and 72 weeks — 72 weeks
Evaluation of Adverse Events based on MedRA based on ITT population
Trial sites (12)
| Facility | City | Region | Status |
|---|---|---|---|
| NorthShore University Health System | Evanston | Illinois | |
| Sterling Research Group | Cincinnati | Ohio | |
| The Lindner Research Center | Cincinnati | Ohio | |
| Metabolic & Atherosclerosis Research Center (MARC) | Cincinnati | Ohio | |
| 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 | |
| Division of Lipidology, Department of Medicine University of Cape Town | Cape Town | Western Province | |
| Ege University Medical School | Izmir | Bornova | |
| Afyonkarahisar Health Sciences University | Afyonkarahisar | Turkey (Türkiye) |
More LIB Therapeutics LLC trials in Norway
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04798430 on ClinicalTrials.gov ↗ ← All trials in Norway