LDL CholesterolPhase 2NCT03549260
Study to Evaluate Efficacy and Safety of LIB003 in Patients on Lipid-Lowering Therapy Needing Additional LDL-C Reduction
A Phase 2 study testing LIB003 in people with LDL Cholesterol, run by LIB Therapeutics LLC at 5 sites in United States.
Trial summary
Study to assess the LDL-C lowering efficacy of different doses of LIB003 administered every 4 weeks in subjects on stable statin and/or ezetimibe therapy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- LDL Cholesterol
- What is being tested?
- LIB003
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 5 sitesUnited States
- Study dates
- 22 May 2018to 30 Nov 2018
- Phase
- Phase 2
- 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
- Male or female, 18 years of age or older
- Elevated LDL-C on current lipid lowering therapy and; prior atherosclerotic cardiovascular disease (ASCVD) event or evidence of ASCVD or without ASCVD but at high risk for ASCVD based on AHA/ACC CVD risk calculator, or aged 40 years and older with diabetes and moderate- to high-intensity statin, or pre-treatment LDL-C 190 mg/dL or greater or heterozygous familial hypercholesterolemia (HeFH)
- Body mass index (BMI) between 18 and 40 kg/m2
Who cannot join
- Females of childbearing potential not using or willing to use an effective form of contraception, or pregnant or breastfeeding, or who have a positive serum pregnancy test at screening
- Homozygous familial hypercholesterolemia
- LDL or plasma apheresis within 2 months; lomitapide or mipomersen within 12 months
- Uncontrolled cardiac arrhythmia, myocardial infarction, unstable angina, PCI, CABG, or stroke within 3 months prior to enrollment
- Uncontrolled cardiac arrhythmia, myocardial infarction, unstable angina, PCI, CABG, or stroke within 3 months prior to enrollment
- Newly diagnosed or poorly controlled (HbA1c >9%) type 2 diabetes
Show all 11Show fewer
- Uncontrolled hypertension
- Moderate to severe renal insufficiency
- Elevated liver function test at screening
- Uncontrolled cardiac arrhythmia or prolonged QT on EKG
- A history of prescription drug abuse, illicit drug use, or alcohol abuse
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Sterling Research Group
Cincinnati, Ohio, 45219
The Lindner Research Center
Cincinnati, Ohio, 45219
Metabolic & Atherosclerosis Research Center (MARC)
Cincinnati, Ohio, 45227
Midwest Institute For Clinical Research
Indianapolis, Indiana, 46260
Louisville Metabolic and Atherosclerosis Research Center
Louisville, Kentucky, 40213
About this study
Official title: Randomized, Double-Blind, Placebo-Controlled, Phase 2, Dose Finding Study to Evaluate the Efficacy and Safety of LIB003 in Patients on Stable Lipid-Lowering Therapy Requiring Additional LDL-C Reduction
Study to assess the LDL-C lowering efficacy of different doses of LIB003 administered every 4 weeks in subjects on stable statin and/or ezetimibe therapy
Read the detailed description
Randomized, Double-Blind, Placebo-Controlled, Phase 2 study to assess the LDL-C lowering efficacy at Week 12 of various doses of LIB003 administered subcutaneously (SC) every 4 weeks (Q4W) in patients with hypercholesterolemia on stable diet and oral LDL-C-lowering drug therapy.
- Conditions
- LDL Cholesterol
- Being tested
- LIB003
- Keywords
- low density lipoprotein cholesterol, PCSK9
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 |
|---|---|---|
| LIB003 150 mg or matching placebo | Experimental | SC LIB003 150 mg or placebo every 4 weeks Receives: Biological: LIB003 |
| LIB003 300 mg or matching placebo | Experimental | SC LIB003 300 mg or placebo every 4 weeks Receives: Biological: LIB003 |
| LIB003 350 mg or matching placebo | Experimental | SC LIB003 350 mg or placebo every 4 weeks Receives: Biological: LIB003 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent reduction in Low Density Lipoprotein Cholesterol (LDL-C) at week 12
Change in serum LDL-C from baseline after 12 weeks
Measured: baseline to 12 weeks
Secondary outcomes (5)
The incidence and severity of treatment emergent adverse events (TEAEs)
safety and tolerability will be based on the incidence and severity of treatment emergent adverse events
Measured: baseline to 12 weeks
Percent reduction in apolipoprotein B (Apo B) at week 12
Change in serum Apo B from baseline after 12 weeks
Measured: baseline to 12 weeks
Percent reduction in lipoprotein (a) [Lp(a)] at week 12
Change in serum Lp(a) from baseline after 12 weeks
Measured: baseline to 12 weeks
Percent reduction in free PCSK9 at week 12
Change in serum free PCSK9 from baseline after 12 weeks
Measured: baseline to 12 weeks
Presence of anti LIB003 antibodies (ADAs)
Measurement of ADAs at baseline and various intervals
Measured: baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2018
- Study start22 May 2018
- Primary completion9 Nov 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LDL CholesterolStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Double-Blind, Placebo-Controlled trial to evaluate LDL-C reduction with 3 different doses of LIB003 compared to placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 81 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, Study director, LIB Therapeutics LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03549260
- Sponsor's protocol ID
- LIB003-002
- Status last verified
- Feb 2019
- First submitted
- 22 May 2018
- Last updated
- 18 Feb 2019
- 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 18 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Placebo-Controlled, Phase 2, Dose Finding Study to Evaluate the Efficacy and Safety of LIB003 in Patients on Stable Lipid-Lowering Therapy Requiring Additional LDL-C Reduction
- ClinicalTrials.gov ID
- NCT03549260
- Acronym / sponsor ID
- LIB003-002
- Conditions
- LDL Cholesterol
- Keywords
- low density lipoprotein cholesterol, PCSK9
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- LIB Therapeutics LLCIndustry (pharma, biotech, devices)
- Collaborators
- Medpace, Inc.
- Study start
- 22 May 2018 (actual)
- Primary completion
- 9 Nov 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 7 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.
Study to assess the LDL-C lowering efficacy of different doses of LIB003 administered every 4 weeks in subjects on stable statin and/or ezetimibe therapy
Detailed description
Randomized, Double-Blind, Placebo-Controlled, Phase 2 study to assess the LDL-C lowering efficacy at Week 12 of various doses of LIB003 administered subcutaneously (SC) every 4 weeks (Q4W) in patients with hypercholesterolemia on 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
- 3
- Model description
- Randomized, Double-Blind, Placebo-Controlled trial to evaluate LDL-C reduction with 3 different doses of LIB003 compared to placebo
| Arm | Type | Receives |
|---|---|---|
| LIB003 150 mg or matching placebo | Experimental | Biological: LIB003SC LIB003 150 mg or placebo every 4 weeks |
| LIB003 300 mg or matching placebo | Experimental | Biological: LIB003SC LIB003 300 mg or placebo every 4 weeks |
| LIB003 350 mg or matching placebo | Experimental | Biological: LIB003SC LIB003 350 mg or placebo every 4 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female, 18 years of age or older
- Elevated LDL-C on current lipid lowering therapy and; prior atherosclerotic cardiovascular disease (ASCVD) event or evidence of ASCVD or without ASCVD but at high risk for ASCVD based on AHA/ACC CVD risk calculator, or aged 40 years and older with diabetes and moderate- to high-intensity statin, or pre-treatment LDL-C 190 mg/dL or greater or heterozygous familial hypercholesterolemia (HeFH)
- Body mass index (BMI) between 18 and 40 kg/m2
Key exclusion criteria (11 listed)
- Females of childbearing potential not using or willing to use an effective form of contraception, or pregnant or breastfeeding, or who have a positive serum pregnancy test at screening
- Homozygous familial hypercholesterolemia
- LDL or plasma apheresis within 2 months; lomitapide or mipomersen within 12 months
- Uncontrolled cardiac arrhythmia, myocardial infarction, unstable angina, PCI, CABG, or stroke within 3 months prior to enrollment
- Uncontrolled cardiac arrhythmia, myocardial infarction, unstable angina, PCI, CABG, or stroke within 3 months prior to enrollment
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 | LIB003 150 mg or matching placebo, LIB003 300 mg or matching placebo, LIB003 350 mg or matching placebo |
Primary outcome
Percent reduction in Low Density Lipoprotein Cholesterol (LDL-C) at week 12
Time frame: baseline to 12 weeks
Change in serum LDL-C from baseline after 12 weeks
5 secondary outcomes
The incidence and severity of treatment emergent adverse events (TEAEs)
Time frame: baseline to 12 weeks
Percent reduction in apolipoprotein B (Apo B) at week 12
Time frame: baseline to 12 weeks
Percent reduction in lipoprotein (a) [Lp(a)] at week 12
Time frame: baseline to 12 weeks
Percent reduction in free PCSK9 at week 12
Time frame: baseline to 12 weeks
Presence of anti LIB003 antibodies (ADAs)
Time frame: baseline to 12 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 18 Feb 2019.
- Individual participant dataSharing planned: No
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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 study director
LIB Therapeutics LLC
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LIB003 in people with LDL Cholesterol, run by LIB Therapeutics LLC at 5 sites 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 3 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 18 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Percent reduction in Low Density Lipoprotein Cholesterol (LDL-C) at week 12 (time frame: baseline to 12 weeks). 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 18 Feb 2019; AzTrials last refreshed its copy on 7 Nov 2026.