HypercholesterolemiaPhase 3LIBerate-VINCT05004675
Trial to Evaluate Efficacy and Safety of LIB003 and Inclisiran in High-risk CVD Patients
A Phase 3 study testing lerodalcibep and Inclisiran in people with Hypercholesterolemia and Atherosclerotic Ischemic Disease, run by LIB Therapeutics LLC at 7 sites in 5 countries.
Trial summary
Comparison of LDL-C reductions of lerodalcibep (LIB003) 300 mg to inclisiran (Leqvio®) 284 in patients at very-high risk or high-risk for CVD on stable diet and oral LDL-C-lowering drug therapy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypercholesterolemia, Atherosclerotic Ischemic Disease
- What is being tested?
- lerodalcibep and Inclisiran
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 7 sitesin 5 countries
- Study dates
- 20 Jun 2022to 15 Oct 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 signed informed consent prior to any study-specific procedure;
- Weight of ≥40 kg (88 lb) and body mass index (BMI) ≥16 and ≤42 kg/m2;
- Very- high or high risk for CVD as defined in 2019 ESC/EAS Guidelines
- High-intensity statin (daily atorvastatin 40/80 or rosuvastatin 20/40) without other acceptable oral lipid lowering treatment plus diet; stable >4 weeks with LDL-C ≥85 mg/dL and triglycerides ≤400 mg/dL
- Women of childbearing potential (WOCBP) must continue using a highly effective form of birth control if sexually active
- Males whose partners are of CBP and not using a highly effective form of birth control will either be surgically sterile or agree to use the following forms of contraception, male or female condom with spermicide
Who cannot join
- Prior or active clinical condition or acute and/or unstable systemic disease, including cancer, compromising patient inclusion or preclude completion of the study, at the discretion of the Investigator
- Homozygous FH
- non-high intensity statins, mipomersen, lomitapide, gemfibrozil, and bempedoic acid
- PCSK9 mAb within 4 weeks of screening or siRNA within 1 year
- Severe renal dysfunction, defined eGFR <30 ml/min
- Recent, within 3 months of screening, atherosclerotic event or intervention
Show all 11Show fewer
- planned cardiac procedure
- NYHA class III or IV heart failure
- active liver disease
- uncontrolled diabetes defined as fasting glucose >200 mg/dL and HbA1c > 9%
- uncontrolled BP ≥180 mmHg systolic or ≥110 mmHg diastolic;
Trial locations and contacts
7 sites in 5 countries.
7 sites in 5 countries
France2 sites
Hopitaux de Marseille
Marseille, Cedex 05, 13385
CHU de Nantes - Hôpital Nord Laennec
Nantes, Cedex 01, 44093
United Kingdom2 sites
Ashton Medical Group
Ashton-under-Lyne, Lancashire, OL6 6EW
Oak Tree Surgery and Pensilva Health Centre
Liskeard, Cornwall, PL14 3XA
Germany1 site
Universitätsklinikum Heidelberg - Medizinische Klinik
Heidelberg, 69120
About this study
Official title: Randomized Open Label, Phase 3 Study to Compare the Efficacy and Safety of Lerodalcibep (LIB003) to Inclisiran in Patients at Very High or High Risk for CVD, on Stable Lipid-Lowering Therapy Requiring Additional LDL-C Reduction
Comparison of LDL-C reductions of lerodalcibep (LIB003) 300 mg to inclisiran (Leqvio®) 284 in patients at very-high risk or high-risk for CVD on stable diet and oral LDL-C-lowering drug therapy
Read the detailed description
Randomized, Open Label (lipids blinded), Phase 3 Study to Evaluate the Efficacy and Safety of Lerodalcibep (LIB003) at Day 270 of subcutaneous (SC) monthly (QM [≤31 days]) lerodalcibep (LIB003) 300 mg administered to SC inclisiran (Leqvio®) 284 mg at Days 1 and 90 in patients with very-high risk or high-risk CVD or at high risk for CVD with LDL-C ≥85 mg/dL on a stable diet and oral LDL-C-lowering drug therapy
- Being tested
- lerodalcibep, Inclisiran
- Keywords
- lerodalcibep, PCSK9 inhibitor, inclisiran
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lerodalcibepBiological
Also called LIB003
300 mg
InclisiranDrug
Also called Leqvio
284 mg
| Study group | Role | What they receive |
|---|---|---|
| lerodalcibep | Experimental | 300 mg SC dosed monthly Receives: Biological: lerodalcibep |
| inclisiran | Active comparator | 284 mg SC dosed Day 1 and Day 90 Receives: Drug: Inclisiran |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL-C change
Percent LDL-C change from baseline
Measured: Day 270
Secondary outcomes (4)
Adverse Events
frequency and severity of injection site reactions (ISRs)
Measured: 270 days
Serum free PCSK9 levels
Percent change in free PCSK9 from baseline
Measured: Day 270
Apolipoproteins
Percent change in Apo B and Lp(a) from baseline
Measured: Day 270
Treatment goal achievement
Percent of patients reaching ESC/EAS treatment goals
Measured: Day 270
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2021
- Study start20 Jun 2022
- Primary completion30 May 2024
- Study completion15 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, comparative trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- LIB Therapeutics LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medpace, Inc.
- Responsible party
- Sponsor
- Investigators
- Evan A Stein, MD PhD, Study director, LIB Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05004675
- Sponsor's protocol ID
- LIB003-012
- Acronym
- LIBerate-VI
- Status last verified
- Oct 2024
- First submitted
- 6 Aug 2021
- Last updated
- 23 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Open Label, Phase 3 Study to Compare the Efficacy and Safety of Lerodalcibep (LIB003) to Inclisiran in Patients at Very High or High Risk for CVD, on Stable Lipid-Lowering Therapy Requiring Additional LDL-C Reduction
- ClinicalTrials.gov ID
- NCT05004675
- Acronym / sponsor ID
- LIBerate-VI / LIB003-012
- Keywords
- lerodalcibep, PCSK9 inhibitor, inclisiran
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- LIB Therapeutics LLCIndustry (pharma, biotech, devices)
- Collaborators
- Medpace, Inc.
- Study start
- 20 Jun 2022 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 15 Oct 2024 (actual)
- First posted
- 13 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparison of LDL-C reductions of lerodalcibep (LIB003) 300 mg to inclisiran (Leqvio®) 284 in patients at very-high risk or high-risk for CVD on stable diet and oral LDL-C-lowering drug therapy
Detailed description
Randomized, Open Label (lipids blinded), Phase 3 Study to Evaluate the Efficacy and Safety of Lerodalcibep (LIB003) at Day 270 of subcutaneous (SC) monthly (QM [≤31 days]) lerodalcibep (LIB003) 300 mg administered to SC inclisiran (Leqvio®) 284 mg at Days 1 and 90 in patients with very-high risk or high-risk CVD or at high risk for CVD with LDL-C ≥85 mg/dL on a stable diet and oral LDL-C-lowering drug therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized, comparative trial
| Arm | Type | Receives |
|---|---|---|
| lerodalcibep | Experimental | Biological: lerodalcibep300 mg SC dosed monthly |
| inclisiran | Active comparator | Drug: Inclisiran284 mg SC dosed Day 1 and Day 90 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Provision of signed informed consent prior to any study-specific procedure;
- Weight of ≥40 kg (88 lb) and body mass index (BMI) ≥16 and ≤42 kg/m2;
- Very- high or high risk for CVD as defined in 2019 ESC/EAS Guidelines
- High-intensity statin (daily atorvastatin 40/80 or rosuvastatin 20/40) without other acceptable oral lipid lowering treatment plus diet; stable >4 weeks with LDL-C ≥85 mg/dL and triglycerides ≤400 mg/dL
- Women of childbearing potential (WOCBP) must continue using a highly effective form of birth control if sexually active
Key exclusion criteria (11 listed)
- Prior or active clinical condition or acute and/or unstable systemic disease, including cancer, compromising patient inclusion or preclude completion of the study, at the discretion of the Investigator
- Homozygous FH
- non-high intensity statins, mipomersen, lomitapide, gemfibrozil, and bempedoic acid
- PCSK9 mAb within 4 weeks of screening or siRNA within 1 year
- Severe renal dysfunction, defined eGFR <30 ml/min
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lerodalcibepAlso: LIB003300 mg | Biological | lerodalcibep |
| InclisiranAlso: Leqvio284 mg | Drug | inclisiran |
Primary outcome
LDL-C change
Time frame: Day 270
Percent LDL-C change from baseline
4 secondary outcomes
Adverse Events
Time frame: 270 days
Serum free PCSK9 levels
Time frame: Day 270
Apolipoproteins
Time frame: Day 270
Treatment goal achievement
Time frame: Day 270
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Hypercholesterolemia
Active, not recruitingObservational study
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A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
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Causes and Natural History of Dyslipidemias
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Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evan A Stein, MD PhD study director
LIB Therapeutics
7 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing lerodalcibep and Inclisiran in people with Hypercholesterolemia and Atherosclerotic Ischemic Disease, run by LIB Therapeutics LLC at 7 sites in 5 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 6 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: finished, as of the sponsor's last update on 23 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France, United Kingdom, Germany, Norway, Spain. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (time frame: Day 270). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Oct 2024.