HypercholesterolemiaPhase 1LIB003SADNCT03545438
Study to Evaluate the Safety, PK, and Pharmacodynamics of LIB003
A Phase 1 study testing LIB003 in people with Hypercholesterolemia, run by LIB Therapeutics LLC at 1 site in United States.
Trial summary
Randomized, double-blind, placebo-controlled, single ascending dose study in nine (9) separate and sequential dose cohorts (7 SC and 2 IV cohorts) to assess the safety and tolerability, pharmacokinetics and pharmacodynamics of LIB003 in subjects with moderately elevated LDL-C levels. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- LIB003
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2017to 30 Jun 2018
- Phase
- Phase 1
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women who are >/=18 and </=70 years of age. Female subjects must be of non-childbearing potential.
- LDL-C >/=100 mg/dL who are either not on a lipid-lowering therapy or who are on stable statin therapy.
- Body mass index (BMI) >18 and <38 kg/m2
- Mild hypertensives on a stable dose of no more than one antihypertensive drug
Who cannot join
- History of any prior or concomitant clinical condition or acute and/or unstable systemic disease compromising subject inclusion
- Systolic blood pressure <90 mmHg or >160 mmHg or diastolic blood pressure <50 or >100 mmHg at screening
- Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen, or hepatitis C virus antibody
- Abnormal liver function test at Screening (aspartate aminotransferase [AST] or alanine aminotransferase [ALT] >2 × the upper limit of normal [ULN]
- Estimated glomerular filtration rate <60 mL/min/1.73 m2 at screening, as determined by the CKD-EPI Equation
- History of prescription drug abuse, illicit drug use (including marijuana), or alcohol abuse
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- Unable to spend 4 days in confinement unit
- History of allergy to protein-based biologics including, but not limited to, mAbs and vaccine
- Any other finding which, in the opinion of the Investigator, would compromise the subject's safety or participation in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of LIB003 in Healthy Subjects With Hypercholesterolemia on Diet or Statin Therapy
Randomized, double-blind, placebo-controlled, single ascending dose study in nine (9) separate and sequential dose cohorts (7 SC and 2 IV cohorts) to assess the safety and tolerability, pharmacokinetics and pharmacodynamics of LIB003 in subjects with moderately elevated LDL-C levels.
Read the detailed description
After meeting eligibility criteria within each cohort subjects will be randomized to receive a single dose of LIB003. Seven (7) cohorts will receive LIB003 escalating doses of LIB003, or placebo, by SC injection and 2 cohorts LIB003 or placebo by IV infusion. Dose escalation will be based on the assessment of safety and tolerability data. All cohorts will each first enroll a sentinel group of subjects who will receive LIB003 or placebo in a double-blind fashion with the remaining subjects in that cohort only to be dosed after the safety data on day 4 from the sentinel subjects has been assessed and deemed safe.
- Conditions
- Hypercholesterolemia
- Being tested
- LIB003
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LIB003Biological
LIB003 or placebo
| Study group | Role | What they receive |
|---|---|---|
| cohort 1 | Placebo comparator | LIB003 dose 1 SC Receives: Biological: LIB003 |
| cohort 2 | Placebo comparator | LIB003 dose 2 SC Receives: Biological: LIB003 |
| cohort 3 | Placebo comparator | LIB003 dose 4 SC Receives: Biological: LIB003 |
| cohort 4 | Placebo comparator | LIB003 dose 4 SC Receives: Biological: LIB003 |
| cohort 5 | Placebo comparator | LIB003 dose 5 SC Receives: Biological: LIB003 |
| cohort 6 | Placebo comparator | LIB003 dose 4 IV Receives: Biological: LIB003 |
| cohort 7 | Placebo comparator | LIB003 dose 5 IV Receives: Biological: LIB003 |
| cohort 8 | Placebo comparator | LIB003 dose 3 SC - statin treated Receives: Biological: LIB003 |
| cohort 9 | Placebo comparator | LIB003 dose 4 SC - statin treated Receives: Biological: LIB003 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence and severity of treatment emergent adverse events (TEAEs)
safety and tolerability will be assessed by the incidence and severity of treatment emergent adverse events
Measured: 43 days
Secondary outcomes (6)
Absolute change in serum unbound (free) proprotein convertase subtilisin/kexin type 9 (PCSK9) concentrations over time
Serum free PCSK9 will be measured at baseline and various time points over 43 days
Measured: 43 days
Absolute change in serum total PCSK9 over time
Serum total PCSK9 will be measured at baseline and various time points over 43 days
Measured: 43 days
Percent change in Low Density Lipoprotein cholesterol (LDL-C) over time
Serum LDL-C will be measured at baseline and various time points over 43 days to derive percent change
Measured: 43 days
Percent change in Apolipoprotein B (Apo B) over time
Serum Apo B will be measured at baseline and various time points over 43 days to derive percent change
Measured: 43 days
Changes in serum LIB003 concentrations over time
serum LIB003 will be measured at various time points to derive AUC (area under curve)
Measured: 43 days
Presence of anti LIB003 antibodies (ADAs)
Measurement of ADAs will be done at baseline and various intervals after LIB003 administration
Measured: 43 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2018
- Study start30 Oct 2017
- Primary completion30 May 2018
- Study completion30 Jun 2018
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- single ascending dose with placebo controll
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 63 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, Medpace Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03545438
- Sponsor's protocol ID
- LIB003-001
- Acronym
- LIB003SAD
- Status last verified
- Jul 2018
- First submitted
- 19 Apr 2018
- Last updated
- 27 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- 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 27 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of LIB003 in Healthy Subjects With Hypercholesterolemia on Diet or Statin Therapy
- ClinicalTrials.gov ID
- NCT03545438
- Acronym / sponsor ID
- LIB003SAD / LIB003-001
- Conditions
- Hypercholesterolemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- LIB Therapeutics LLCIndustry (pharma, biotech, devices)
- Collaborators
- Medpace, Inc.
- Study start
- 30 Oct 2017 (actual)
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 4 Jun 2018 (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.
Randomized, double-blind, placebo-controlled, single ascending dose study in nine (9) separate and sequential dose cohorts (7 SC and 2 IV cohorts) to assess the safety and tolerability, pharmacokinetics and pharmacodynamics of LIB003 in subjects with moderately elevated LDL-C levels.
Detailed description
After meeting eligibility criteria within each cohort subjects will be randomized to receive a single dose of LIB003. Seven (7) cohorts will receive LIB003 escalating doses of LIB003, or placebo, by SC injection and 2 cohorts LIB003 or placebo by IV infusion. Dose escalation will be based on the assessment of safety and tolerability data. All cohorts will each first enroll a sentinel group of subjects who will receive LIB003 or placebo in a double-blind fashion with the remaining subjects in that cohort only to be dosed after the safety data on day 4 from the sentinel subjects has been assessed and deemed safe.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 9
- Model description
- single ascending dose with placebo controll
| Arm | Type | Receives |
|---|---|---|
| cohort 1 | Placebo comparator | Biological: LIB003LIB003 dose 1 SC |
| cohort 2 | Placebo comparator | Biological: LIB003LIB003 dose 2 SC |
| cohort 3 | Placebo comparator | Biological: LIB003LIB003 dose 4 SC |
| cohort 4 | Placebo comparator | Biological: LIB003LIB003 dose 4 SC |
| cohort 5 | Placebo comparator | Biological: LIB003LIB003 dose 5 SC |
| cohort 6 | Placebo comparator | Biological: LIB003LIB003 dose 4 IV |
| cohort 7 | Placebo comparator | Biological: LIB003LIB003 dose 5 IV |
| cohort 8 | Placebo comparator | Biological: LIB003LIB003 dose 3 SC - statin treated |
| cohort 9 | Placebo comparator | Biological: LIB003LIB003 dose 4 SC - statin treated |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women who are >/=18 and </=70 years of age. Female subjects must be of non-childbearing potential.
- LDL-C >/=100 mg/dL who are either not on a lipid-lowering therapy or who are on stable statin therapy.
- Body mass index (BMI) >18 and <38 kg/m2
- Mild hypertensives on a stable dose of no more than one antihypertensive drug
Key exclusion criteria (9 listed)
- History of any prior or concomitant clinical condition or acute and/or unstable systemic disease compromising subject inclusion
- Systolic blood pressure <90 mmHg or >160 mmHg or diastolic blood pressure <50 or >100 mmHg at screening
- Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen, or hepatitis C virus antibody
- Abnormal liver function test at Screening (aspartate aminotransferase [AST] or alanine aminotransferase [ALT] >2 × the upper limit of normal [ULN]
- Estimated glomerular filtration rate <60 mL/min/1.73 m2 at screening, as determined by the CKD-EPI Equation
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 |
|---|---|---|
| LIB003LIB003 or placebo | Biological | cohort 1, cohort 2, cohort 3, cohort 4, cohort 5, cohort 6, cohort 7, cohort 8, cohort 9 |
Primary outcome
The incidence and severity of treatment emergent adverse events (TEAEs)
Time frame: 43 days
safety and tolerability will be assessed by the incidence and severity of treatment emergent adverse events
6 secondary outcomes
Absolute change in serum unbound (free) proprotein convertase subtilisin/kexin type 9 (PCSK9) concentrations over time
Time frame: 43 days
Absolute change in serum total PCSK9 over time
Time frame: 43 days
Percent change in Low Density Lipoprotein cholesterol (LDL-C) over time
Time frame: 43 days
Percent change in Apolipoprotein B (Apo B) over time
Time frame: 43 days
Changes in serum LIB003 concentrations over time
Time frame: 43 days
Presence of anti LIB003 antibodies (ADAs)
Time frame: 43 days
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 27 Jul 2018.
- Individual participant dataSharing planned: No
Related trials for Hypercholesterolemia
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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
Medpace Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LIB003 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 4 inclusion and 9 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 27 Jul 2018. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The incidence and severity of treatment emergent adverse events (TEAEs) (time frame: 43 days). 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 27 Jul 2018.