Cardiovascular Disease With Mention of ArteriosclerosisPhase 3LIBerate-OLENCT04798430

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

A Phase 3 study testing lerodalcibep in people with Cardiovascular Disease With Mention of Arteriosclerosis and Elevated Cholesterol, run by LIB Therapeutics LLC at 12 sites in 6 countries.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 10 years and older
Conditions the study is for: Cardiovascular Disease With Mention of Arteriosclerosis, Elevated Cholesterol, Familial Hypercholesterolemia
What is being tested?: lerodalcibep
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2,000 participants
Where: 12 sitesin 6 countries
Study dates: 3 Dec 2020to 31 Dec 2025
Phase: Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 10 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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,

Who cannot join

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;

Trial locations and contacts

12 sites in 6 countries. Contact the study team or a site near you to ask about taking part.

Country

City, postcode or hospital

12 sites in 6 countries

United States4 sites

Sterling Research Group
Cincinnati, Ohio, 45219
The Lindner Research Center
Cincinnati, Ohio, 45219
Metabolic & Atherosclerosis Research Center (MARC)
Cincinnati, Ohio, 45227
NorthShore University Health System
Evanston, Illinois, 60201

Other trials in United States

Israel2 sites

Department of Medicine, Hadassah University Hospital
Jerusalem, 12000
Rabin Medical Center, Beilinson Hospital,
Petah Tikva, 49100

Other trials in Israel

South Africa2 sites

Division of Lipidology, Department of Medicine University of Cape Town
Cape Town, Western Province, 7925
Carbohydrate and Lipid Metabolism Research Unit
Johannesburg, Gauteng, 2193

Other trials in South Africa

Turkey (Türkiye)2 sites

Afyonkarahisar Health Sciences University
Afyonkarahisar
Ege University Medical School
Izmir, Bornova, 35040

Other trials in Turkey (Türkiye)

India1 site

G.B. Pant Institute of Postgraduate Medical Education & Research
New Delhi, 110002

Other trials in India

Norway1 site

Lipid Clinic, Oslo University Hospital
Oslo, 0586

Other trials in Norway

About this study

Official title: Open-Label Extension Phase 3 Study to Evaluate the Long-Term Efficacy and Safety of LIB003 in Patients With HoFH and HeFH, CVD, or at High Risk for CVD, on Stable Lipid-Lowering Therapy Requiring Additional LDL-C Reduction

Read the detailed description

The population for this open-label study includes patients who successfully complete one of the randomized, controlled (placebo or comparator) blinded Phase 3 base studies (LIB003-003, LIB003-004, LIB003-005, LIB003-006, LIB003-008, LIB003-011 and LIB003-012). Patients will continue to maintain their existing oral lipid-lowering therapy (LLT).

Following completion of a base study and providing informed consent, patients will receive doses of LIB003 300 mg Q4W (<31 days) on Day 1 and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, and 68. Patients will be seen in the clinic Q4W (<31 days) for at least the initial 12 weeks and then every 12 weeks (Weeks 24, 36, 48, 60, and 72) with the interim Q4W (<31 days) doses administered at home.

Patients may begin the OLE on the final visit of their prior study after completion of all requirements for that trial. Their lipids will remain blinded (to patient, study staff and sponsor) until week 4 to avoid any unblinding of the prior trial. Thereafter lipid results will be unblinded throughout the remainder of the 72 week trial.

Conditions: Cardiovascular Disease With Mention of Arteriosclerosis, Elevated Cholesterol, Familial Hypercholesterolemia
Being tested: lerodalcibep
Keywords: lerodalcibep, PCSK9 inhibitor
Medical subject headings: Hypercholesterolemia, Hyperlipoproteinemia Type II

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

lerodalcibepDrug
Also called LIB003
PCSK9 inhibitor

Study groups in NCT04798430
Study group	Role	What they receive
LIB003 (lerodalcibep)	Experimental	300 mg monthly (Q4W) by subcutaneous injection Receives: Drug: lerodalcibep

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (2)

Immunogenicity
Incidence of anti-drug antibodies
Measured: 72 weeks
LDL Cholesterol reduction
Percent decrease in LDL-C from baseline of original study
Measured: 72 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Dec 202031 Dec 2025

First posted15 Mar 2021
Study start3 Dec 2020
Primary completion30 Jul 2025 (estimated)
Study completion31 Dec 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Cardiovascular Disease With Mention of ArteriosclerosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: open label extension trial
Masking: None (open label)
Enrolment: 2,000 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04798430
Sponsor's protocol ID: LIB003-007
Acronym: LIBerate-OLE
Status last verified: Oct 2024
First submitted: 9 Mar 2021
Last updated: 22 Oct 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Raal FJ, Fourie N, Scott R, Blom DJ, Basson MMV, Kayikcioglu M, Roth M, Vest J, Kallend D, Stein EA. Response to PCSK9 Inhibition Based on LDL Receptor Function in Familial Hypercholesterolemia: A Nonrandomized Clinical Trial. JAMA Cardiol. 2026 Jun 1;11(6):593-598. doi: 10.1001/jamacardio.2026.0879.
PubMed 42054033