HypercholesterolemiaPhase 3NCT05234775
Cross-Over Study to Compare the Pharmacokinetics and Pharmacodynamics of LIB003 Process 1 and Process 2 Drug Product
A Phase 3 study testing lerodalcibep in people with Hypercholesterolemia, run by LIB Therapeutics LLC at 1 site in United States.
Trial summary
To compare the pharmacokinetics (PK), and pharmacodynamics (PD) of single subcutaneous (SC) doses of 300 mg LIB003 Process 1 (P1) and Process 2 (P2) drug product in subjects with or without statin therapy Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- lerodalcibep
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jan 2022to 11 Jul 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provision of written and signed informed consent prior to any study-specific procedure
- LDL-C 70 mg/dL or above on stable diet alone or diet plus statin
- Weight of 40 kg (88 lb) and body mass index (BMI) between 17 and 42 kg/m2
- Females of childbearing potential must be using a highly effective form of birth control
- Male subjects will either be surgically sterile or agree, or partner agrees, to use highly effective form of birth control
Who cannot join
- Fasting triglyceride >400 mg/dL
- excluded lipid lowering medication
- severe renal impairment (eGFR <30 ml/min)
- fasting glucose >200 mg/dL plus HbA1c >9%
- hepatic transaminases >2.5 x ULN for laboratory
- History of any prior or active clinical condition or acute and/or unstable systemic disease compromising subject inclusion, at the discretion of the Investigator,
- NYHA class III-IV heart failure or last documented left ventricular EF <30%
- Any severe or clinically significant advert event, laboratory abnormality, intercurrent illness, or other medical condition which indicates to the Investigator that continued participation is not in the best interest of the subject
Trial locations and contacts
1 site in 1 country.
United States1 site
Metabolic & Atherosclerosis Research Center (MARC)
Cincinnati, Ohio, 45227
About this study
Official title: Cross-Over Study to Compare the Pharmacokinetics and Pharmacodynamics of LIB003 Process 1 and Process 2 Drug Product in Subjects With or Without Statin Therapy
To compare the pharmacokinetics (PK), and pharmacodynamics (PD) of single subcutaneous (SC) doses of 300 mg LIB003 Process 1 (P1) and Process 2 (P2) drug product in subjects with or without statin therapy
Read the detailed description
Comparison of the pharmacokinetics (PK), and pharmacodynamics (free PCSK9 and LDL-C) of single subcutaneous (SC) doses of 300 mg of both LIB003 drug product manufactured by Process 1 (P1) and Process 2 (P2) in subjects with or without statin therapy
- Conditions
- Hypercholesterolemia
- Being tested
- lerodalcibep
- Medical subject headings
- 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 of each drug given SC as single dose
| Study group | Role | What they receive |
|---|---|---|
| LIB003 (lerodalcibep) Process 1 | Experimental | 300 mg LIB003 Process 1 drug product administered SC Receives: Drug: lerodalcibep |
| LIB003 (lerodalcibep) Process 2 | Active comparator | 300 mg LIB003 Process 2 drug product administered SC Receives: Drug: lerodalcibep |
What is being measured
The primary outcome is the main question the study is designed to answer.
pharmacodynamics
comparison of free PCSK9 reductions from baseline between P1 and P2
Measured: 4 weeks
Cmax pharmacokinetics
comparison of serum lerodalcibep Cmax between P1 and P2
Measured: 4 weeks
AUC 0-last pharmacokinetics
comparison of serum lerodalcibep AUC 0-last between P1 and P2
Measured: 4 weeks
T-Half pharmacokinetics
comparison of serum lerodalcibep T-HALF between P1 and P2
Measured: 4 weeks
Secondary outcomes (1)
comparison of LDL-C
comparison of serum LDL-C reductions from baseline to week 4 between P1 and P2
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start28 Jan 2022
- Primary completion30 Jun 2022
- Study completion11 Jul 2022
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
- Non-randomised
- Intervention model
- Crossover
- Model description
- assignment to initial treatment group with cross over to alternate treatment group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- LIB Therapeutics LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medpace, Inc.
- Responsible party
- Sponsor
- Investigators
- Traci A Turner, MD, Principal investigator, Metabolic & Atherosclerosis Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05234775
- Sponsor's protocol ID
- LIB003-014
- Status last verified
- Jul 2022
- First submitted
- 17 Jan 2022
- Last updated
- 14 Jul 2022
- 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 14 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-Over Study to Compare the Pharmacokinetics and Pharmacodynamics of LIB003 Process 1 and Process 2 Drug Product in Subjects With or Without Statin Therapy
- ClinicalTrials.gov ID
- NCT05234775
- Acronym / sponsor ID
- LIB003-014
- Conditions
- Hypercholesterolemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- LIB Therapeutics LLCIndustry (pharma, biotech, devices)
- Collaborators
- Medpace, Inc.
- Study start
- 28 Jan 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 11 Jul 2022 (actual)
- First posted
- 10 Feb 2022 (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.
To compare the pharmacokinetics (PK), and pharmacodynamics (PD) of single subcutaneous (SC) doses of 300 mg LIB003 Process 1 (P1) and Process 2 (P2) drug product in subjects with or without statin therapy
Detailed description
Comparison of the pharmacokinetics (PK), and pharmacodynamics (free PCSK9 and LDL-C) of single subcutaneous (SC) doses of 300 mg of both LIB003 drug product manufactured by Process 1 (P1) and Process 2 (P2) in subjects with or without statin therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- assignment to initial treatment group with cross over to alternate treatment group
| Arm | Type | Receives |
|---|---|---|
| LIB003 (lerodalcibep) Process 1 | Experimental | Drug: lerodalcibep300 mg LIB003 Process 1 drug product administered SC |
| LIB003 (lerodalcibep) Process 2 | Active comparator | Drug: lerodalcibep300 mg LIB003 Process 2 drug product administered SC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Provision of written and signed informed consent prior to any study-specific procedure
- LDL-C 70 mg/dL or above on stable diet alone or diet plus statin
- Weight of 40 kg (88 lb) and body mass index (BMI) between 17 and 42 kg/m2
- Females of childbearing potential must be using a highly effective form of birth control
- Male subjects will either be surgically sterile or agree, or partner agrees, to use highly effective form of birth control
Key exclusion criteria (8 listed)
- Fasting triglyceride >400 mg/dL
- excluded lipid lowering medication
- severe renal impairment (eGFR <30 ml/min)
- fasting glucose >200 mg/dL plus HbA1c >9%
- hepatic transaminases >2.5 x ULN for laboratory
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 of each drug given SC as single dose | Drug | LIB003 (lerodalcibep) Process 1, LIB003 (lerodalcibep) Process 2 |
Primary outcome
pharmacodynamics
Time frame: 4 weeks
comparison of free PCSK9 reductions from baseline between P1 and P2
Cmax pharmacokinetics
Time frame: 4 weeks
comparison of serum lerodalcibep Cmax between P1 and P2
AUC 0-last pharmacokinetics
Time frame: 4 weeks
comparison of serum lerodalcibep AUC 0-last between P1 and P2
T-Half pharmacokinetics
Time frame: 4 weeks
comparison of serum lerodalcibep T-HALF between P1 and P2
1 secondary outcome
comparison of LDL-C
Time frame: 4 weeks
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 14 Jul 2022.
- 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.
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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.
Traci A Turner, MD principal investigator
Metabolic & Atherosclerosis Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing lerodalcibep in people with Hypercholesterolemia, run by LIB Therapeutics LLC at 1 site in United States.
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 5 inclusion and 8 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 14 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
pharmacodynamics (time frame: 4 weeks). The study lists 4 primary outcomes in all. 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 14 Jul 2022.