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Cardiovascular Risk FactorPhase 3LIBerate-HRNCT04806893

Study of Long-Term Efficacy and Safety of LIB003 in CVD or High Risk for CVD Patients Needing Further LDL-C Reduction

A Phase 3 study testing lerodalcibep in people with Cardiovascular Risk Factor and Cardiovascular Diseases, run by LIB Therapeutics LLC at 6 sites in 3 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study is to assess LDL-C reductions at Week 52 with monthly (Q4W [≤31 days]) dosing of LIB003 (lerodalcibep) 300 mg administered subcutaneously (SC) compared to placebo in patients with CVD, or at high risk for CVD, on a stable diet and oral LDL-C lowering drug therapy Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
lerodalcibep
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
900 participants
Where
6 sitesin 3 countries
Study dates
22 Apr 2021to 28 Feb 2024
Phase
Phase 3
Are there results?
None posted in the registry

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Provision of written and signed informed consent prior to any study-specific procedure;
  • Weight of ≥40 kg (88 lb) and body mass index (BMI) ≥17 and ≤42 kg/m2;
  • History of CVD, (including cerebrovascular or peripheral arterial disease) or very-high risk for CVD as defined in the 2019 ESC/EAS Guidelines or
  • High risk for CVD as defined in the 2019 ESC/EAS Guidelines
  • At Screening or post Washout/Stabilization, LDL-C ≥70 mg/dL and TG ≤400 mg/dL while on stable lipid-lowering oral drug therapy (i.e., maximally tolerated statin with or without ezetimibe); Patients unable to tolerate approved doses of a statin may take lower than approved doses and dose less frequently than daily as long as the dose and dosing frequency is consistent; Patients with documentation of inability to tolerate any statin at any dose, or history of rhabdomyolysis, may also participate;
  • Stable diet and lipid-lowering oral therapies (such as statins, ezetimibe, bile-acid sequestrants, OM-3 compounds, fenofibrate, bezafibrate, nicotinic acid, and bempedoic acid) or combinations thereof for at least 4 weeks
  • Patients on a PCSK9 mAb at a dose of 75 mg, 140 mg, or 150 mg Q2W must undergo a washout period of ≥4 weeks after the last dose; for those on 300 mg or 420 mg Q4W (≤31 days) the washout period is ≥8 weeks following last dose;
  • Females of childbearing potential must be using a highly effective form of birth control if sexually active and have a negative urine pregnancy test at the last Screening Visit;

Who cannot join

  • Use of prohibited oral lipid-lowering agents mipomersen or lomitapide within 6 months of screening, gemfibrozil within 6 weeks of screening, apheresis within 2 months prior to randomization; received other investigational agent(s) such as PCSK9 or Lp(a) siRNA or locked nucleic acid-reducing agents within 12 months of the Screening Visit;
  • Documented history of HoFH defined clinically or genetically
  • History of any prior or active clinical condition or acute and/or unstable systemic disease compromising patient inclusion, at the discretion of the Investigator
  • Females of childbearing potential who are sexually active, not using or unwilling to use a highly effective form of contraception, pregnant or breastfeeding, or who have a positive urine pregnancy test at the last Screening Visit;
  • Moderate to severe renal dysfunction, defined as an eGFR <30 mL/min/1.73m2
  • Active liver disease or hepatic dysfunction, history of liver transplant, and/or ALT or AST >2.5 × the ULN as determined by central laboratory analysis at screening
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  • Uncontrolled thyroid disease: hyperthyroidism or hypothyroidism
  • Uncontrolled Type 1 or Type 2 DM, defined as FBS ≥200 mg/dL or HbA1C ≥9%;
  • Uncontrolled serious cardiac arrhythmia, MI, unstable angina, PCI, CABG, placement of implantable cardioverter defibrillator or biventricular pacemaker, aortic valve surgery, or stroke within 3 months prior to the Screening Visit;
  • Planned cardiac surgery or revascularization;
  • New York Heart Association class III-IV heart failure

Trial locations and contacts

6 sites in 3 countries.

6 sites in 3 countries

United States3 sites

  • Sterling Research Group

    Cincinnati, Ohio, 45219

  • The Lindner Research Center

    Cincinnati, Ohio, 45219

  • Metabolic & Atherosclerosis Research Center (MARC)

    Cincinnati, Ohio, 45227

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

India1 site

  • G.B. Pant Institute of Postgraduate Medical Education & Research

    New Delhi, 110002

Other trials in India

About this study

Official title: Study to Evaluate the Long-Term Efficacy and Safety of LIB003 in Patients With Cardiovascular Disease, or at High Risk for Cardiovascular Disease, on Stable Lipid-Lowering Therapy Requiring Additional LDL-C Reduction

This study is to assess LDL-C reductions at Week 52 with monthly (Q4W [≤31 days]) dosing of LIB003 (lerodalcibep) 300 mg administered subcutaneously (SC) compared to placebo in patients with CVD, or at high risk for CVD, on a stable diet and oral LDL-C lowering drug therapy

Read the detailed description

Randomized, double-blind, placebo-controlled, Phase 3 study of 52 weeks duration.

Patients who fulfill the inclusion and exclusion criteria will be enrolled at up to 65 sites in the United States, Canada, Europe, South Africa, Asia, Australasia, and the Middle East. Patients will be randomized in a 2:1 ratio to LIB003 or placebo. The total study duration will be up to 63 weeks which includes up to a Screening Period and 52 weeks of study drug treatment. Following randomization patients will be dosed and seen in the clinic Q4W (≤31 days).

Being tested
lerodalcibep, Placebo
Keywords
lerodalcibep, PCSK9 inhibitor
Medical subject headings
Cardiovascular Diseases, Myocardial Infarction, Hypercholesterolemia

What participants receive

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

  • lerodalcibepDrug

    Also called LIB003

    300 mg subcutaneous injection every month (Q4W)

  • PlaceboOther

    matching subcutaneous injection every month (Q4W)

Study groups in NCT04806893
Study groupRoleWhat they receive
LIB003 (lerodalcibep)Experimental300 mg subcutaneously monthly (Q4W)
Receives: Drug: lerodalcibep
PlaceboPlacebo comparatormatching placebo subcutaneously monthly (Q4W)
Receives: Other: Placebo

What is being measured

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

  1. LDL-C change compared to placebo

    Percent change in LS mean from baseline compared to placebo in LDL-C level

    Measured: 52 weeks

  2. mean LDL-C change at week 50 and 52

    Percent change in LS mean from baseline compared to placebo in LDL-C level at Weeks 50 and 52

    Measured: 50 and 52 weeks

Secondary outcomes (3)

  1. Incidence of Treatment-Emergent Adverse Events as assessed by Medical Dictionary for Regulatory Activities as severe, moderate or mild after 52 weeks

    Evaluation of Adverse Events based on MedRA based on ITT population

    Measured: 52 weeks

  2. Change in Free PCSK9

    Percent change in LS mean from baseline compared to placebo in free PCSK9

    Measured: 52 weeks

  3. Percentage of patients achieving 2019 ESC/EAS LDL-C goals

    To assess the effects of LIB003 on the percentage of patients achieving an LDL-C <40 mg/dL, 55 mg/dL, <70 mg/dL, and 100 mg/dL

    Measured: 52 weeks

Timeline

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

  1. First posted19 Mar 2021
  2. Study start22 Apr 2021
  3. Primary completion15 Nov 2023
  4. Study completion28 Feb 2024 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Model description
Placebo-controlled, randomized 2:1 to Active or placebo
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
900 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04806893
Sponsor's protocol ID
LIB003-006
Acronym
LIBerate-HR
Status last verified
Dec 2023
First submitted
16 Mar 2021
Last updated
11 Dec 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Klug EQ, Llerena S, Burgess LJ, Fourie N, Scott R, Vest J, Caldwell K, Kallend D, Stein EA; LIBERATE-HR Investigators. Efficacy and Safety of Lerodalcibep in Patients With or at High Risk of Cardiovascular Disease: A Randomized Clinical Trial. JAMA Cardiol. 2024 Sep 1;9(9):800-807. doi: 10.1001/jamacardio.2024.1659.

    PubMed 38958989

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing lerodalcibep in people with Cardiovascular Risk Factor and Cardiovascular Diseases, run by LIB Therapeutics LLC at 6 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States, Israel, India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

LDL-C change compared to placebo (time frame: 52 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04806893, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2023.

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