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Clinical Trials in India / NCT04798430
Enrolling by invitation Phase 3

Long-term Efficacy and Safety of OLE LIB003 in HoFH, HeFH, and High-risk CVD Patients Requiring Further LDL-C Reduction

NCT04798430 · tracked via the Priya Life Science India tracker
Sponsor
LIB Therapeutics LLC
Phase
Phase 3
Started
2020-12-03
Last updated
2024-10-22

Condition(s) studied

Cardiovascular Disease With Mention of ArteriosclerosisElevated CholesterolFamilial Hypercholesterolemia

Investigational drug(s) / intervention(s)

lerodalcibep

lerodalcibep: PCSK9 inhibitor

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

Sex
ALL
Min age
10 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Successful completion 1 of one of the Phase 3 base studies LIB003-003, LIB003-004, LIB003-005, LIB003-006, LIB003-008, LIB003-011 and LIB003-012 without SAEs related to LIB003; or * Provision of written and signed informed consent prior to any study-specific procedure; * Female patients of childbearing potential must be using a highly effective form of birth control if sexually active and have a negative urine pregnancy test on Day 1 prior to dosing; * Patient is willing to maintain appropriate diet and stable dose of current lipid-lowering therapy including statins, ezetimibe, bile acid sequestrants, niacin, bempedoic acid, bezafibrate or fenofibrate, and/or OM-3 compounds; and * Patient is considered by the Investigator to be otherwise healthy, Exclusion Criteria: * Failure to complete a base Phase 3 (LIB003-003, LIB003-004, LIB003-005, LIB003-006, LIB003-008, LIB003-011 and LIB003-012) study and/or had an SAE that was related to study drug during the base Phase 3 study; * Development since the final visit in the base Phase 3 (LIB003-003, LIB003-004, LIB003-005, LIB003-006, LIB003-008, LIB003-011 or LIB003-012) study of any concomitant clinical condition or acute and/or unstable systemic disease compromising patient inclusion, at the discretion of the Investigator, * Use of prohibited oral lipid-lowering agents PCSK9 mAbs, mipomersen, lomitapide gemfibrozil (or bempedoic acid for LIB003, -011) following the base study or the use of PCSK9 short interfering ribonucleic acid (siRNA), or locked nucleic acid-reducing agents (LNA) within the last 6 months; * Not available for protocol-required study visits or procedures, to the best of the patient's and Investigator's knowledge; * Has any other finding which, in the opinion of the Investigator, would compromise the patient's safety or participation in the study;

Primary outcome measure(s)

Trial sites (12)

FacilityCityRegionStatus
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)
Official registry record

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 India