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

{ "Long-term Study of Lerodalcibep for High Cholesterol and Heart Disease", "This study is looking at the long-term safety and effectiveness of lerodalcibep, a drug for lowering cholesterol. It's for people who have high cholesterol conditions like Familial Hypercholesterolemia (HoFH and HeFH) or are at high risk for heart disease, and who have already completed a previous study with lerodalcibep. Participants will receive lerodalcibep as a shot under the skin once a month for 72 weeks, in addition to their current cholesterol-lowering medicines. The main goal is to see how many side effects occur over 72 weeks. The study plans to enroll about 2000 participants aged 10 and older. The current recruitment status is unclear.", "design": "This is an open-label study, meaning both you and the study staff will know you are receiving lerodalcibep. It involves about 2000 participants who previously completed a Phase 3 study.", "commitments": "You will receive monthly injections of lerodalcibep for 72 weeks. You will have clinic visits every 4 weeks for the first 12 weeks, then every 12 weeks after that, with some doses given at home.", "compensation": "Not stated in the trial record.", "follow_up": "Your safety will be monitored for 72 weeks after starting the treatment.", }

Study design: Not specified.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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

Enrolling by Invitation

PHASE3Ages 10+InterventionalTreatment

LIB Therapeutics LLC

~2,000 participants

Updated 2024-10-22 on ClinicalTrials.gov

What's tested:lerodalcibep

At a glance

Recruiting sites

0 of 12 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Incidence of Treatment-Emergent Adverse Events as assessed by Medical Dictionary for Regulatory Activities as severe, moderate or mild after 48 and 72 weeks

Measured over 72 weeks

Conditions

Cardiovascular Disease With Mention of Arteriosclerosis

Elevated Cholesterol

Familial Hypercholesterolemia

NCT04798430

Where you'd take part

This study runs at 12 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

Afyonkarahisar Health Sciences University
Afyonkarahisar, Turkey (Türkiye)no site contact published
Carbohydrate and Lipid Metabolism Research Unit
Johannesburg, Gauteng, South Africano site contact published
Department of Medicine, Hadassah University Hospital
Jerusalem, Israelno site contact published
Division of Lipidology, Department of Medicine University of Cape Town
Cape Town, Western Province, South Africano site contact published
Ege University Medical School
Izmir, Bornova, Turkey (Türkiye)no site contact published
G.B. Pant Institute of Postgraduate Medical Education & Research
New Delhi, Indiano site contact published
Lipid Clinic, Oslo University Hospital
Oslo, Norwayno site contact published
Metabolic & Atherosclerosis Research Center (MARC)
Cincinnati, Ohiono site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

David Kallend, MB BCh · STUDY_DIRECTOR · LIB Therapeutics

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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

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;

What this trial measures

Incidence of Treatment-Emergent Adverse Events as assessed by Medical Dictionary for Regulatory Activities as severe, moderate or mild after 48 and 72 weeks72 weeks
Evaluation of Adverse Events based on MedRA based on ITT population

Trialytics