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To assess the longer term safety, tolerability, and LDL C lowering efficacy after 52 weeks of additional treatment with LIB003 with subcutaneous (SC) dosing every 4 weeks (Q4W)
To assess the longer term safety, tolerability, immunogenicity, PK, PD and LDL C lowering efficacy after 52 weeks of additional treatment with LIB003 with subcutaneous (SC) dosing every 4 weeks (Q4W) in patients on stable maximally tolerated statins with or without ezetimibe who completed the phase 2 dose ranging trial LIB003-002
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LIB003 | Experimental | LIB003 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LIB003 | Drug | 300 mg SC Q4W |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | safety and tolerability will be based on the incidence and severity of treatment emergent adverse events | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in LDL-C at 52 Weeks | percent change in serum LDL-C from baseline at 52 weeks | 52 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Evan A Stein, MD PhD | LIB Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sterling Research Group | Cincinnati | Ohio | 45219 | United States | ||
| The Lindner Research Center |
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patients who had completed the phase 2 dose ranging trial were eligible for this open label extension trial.
4 clinical centers in USA, recruitment from patients completing a phase 2 dose ranging trial (LIB003-002)
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| ID | Title | Description |
|---|---|---|
| FG000 | LIB003 (Lerodalcibep) | LIB003 (lerodalcibep) LIB003: 300 mg SC Q4W |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Subjects with CVD or high risk for CVD on maximally tolerated statin completing 12 week Phase 2 LIB003-002 dose ranging trial
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| ID | Title | Description |
|---|---|---|
| BG000 | LIB003 | LIB003 LIB003: 300 mg SC Q4W |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | safety and tolerability will be based on the incidence and severity of treatment emergent adverse events | SAE | Posted | Count of Participants | Participants | 52 weeks |
|
|
52 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LIB003 (Lerodalcibep) | LIB003 (lerodalcibep) LIB003: 300 mg SC Q4W | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| supraventricular tachycardia | Cardiac disorders | MedDRA (10.1) | Systematic Assessment | considered unrelated to study drug by PI |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Other Adverse Event | General disorders | MedDRA (10.1) | Systematic Assessment | mild, moderate |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Evan A Stein MD PhD FACC | LIB Therapeutics | 18596533141 | estein@libtherapeutics.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 18, 2020 | Sep 7, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 20, 2020 | Sep 7, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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open-label
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| Cincinnati |
| Ohio |
| 45219 |
| United States |
| Metabolic & Atherosclerosis Research Center (MARC) | Cincinnati | Ohio | 45227 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Subjects with CVD or high risk for CVD on maximally tolerated statin completing 12 week Phase 2 LIB003-002 dose ranging trial - self identifying | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| BMI | kilograms per meter squared on body surface aea | Mean | Full Range | kg/m^2 |
|
|
| Secondary | Percent Change in LDL-C at 52 Weeks | percent change in serum LDL-C from baseline at 52 weeks | Intent to treat | Posted | Mean | Standard Deviation | percentage from baseline | 52 weeks |
|
|
|
| 32 |
| 3 |
| 32 |
| 28 |
| 32 |
|
| small bowel obstruction | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment | considered unrelated to study drug by PI |
|
| worsening of uterine fibroids | Reproductive system and breast disorders | MedDRA (10.1) | Systematic Assessment | considered unrelated to study drug by PI |
|
| Other (Not Including Serious) Adverse Events were not monitored/assessed using specific Adverse Even | Skin and subcutaneous tissue disorders | MedDRA (10.1) | Systematic Assessment | injection site reactions |
|
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| D009750 |
| Nutritional and Metabolic Diseases |