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Evaluation of the clinical profile (lipid efficacy, safety and PK) across a number of doses of CIVI 007, a PCSK9 inhibitor. Patients to be evaluated will be on a stable background of statin therapy with or without ezetimibe.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CIVI 007, Dose A | Experimental | Subcutaneous (SC) injection of a PCSK9 inhibitor- low dose given twice |
|
| CIVI 007, Dose B | Experimental | SC injection of PCSK9 inhibitor- dose titration |
|
| CIVI 007, Dose C | Experimental | SC injection of PCSK9 inhibitor- high dose given twice |
|
| Placebo | Placebo Comparator | Placebo SC injection matching PCSK9 inhibitor given twice |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CIVI 007 | Drug | hypercholesterolemia agent |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the Pharmacodynamic Effect of CIVI 007 | Percent change from baseline in PCSK9 | Baseline, D29, D57, D85 |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the Lipid Efficacy of CIVI 007 | Percent change from baseline in LDL-C | Baseline, Day 29, Day 57, Day 85 |
| Assessment of CIVI 007 Adverse Events (AEs) | Incidence of any drug-related AEs |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charles L Shear, DrPH | CiVi Biopharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Jacksonville | Florida | 32216 | United States | ||
| Research Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo SC injection matching PCSK9 inhibitor given twice |
| FG001 | Experimental: CIVI 007, Dose A | Subcutaneous (SC) injection of a PCSK9 inhibitor- low dose given twice |
| FG002 | Experimental: CIVI 007, Dose B | SC injection of PCSK9 inhibitor- dose titration |
| FG003 | Experimental: CIVI 007, Dose C | SC injection of PCSK9 inhibitor- high dose given twice |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CIVI 007, Dose A | Subcutaneous (SC) injection of a PCSK9 inhibitor- low dose given twice CIVI 007: hypercholesterolemia agent |
| BG001 | CIVI 007, Dose B | SC injection of PCSK9 inhibitor- dose titration CIVI 007: hypercholesterolemia agent |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Assessment of the Pharmacodynamic Effect of CIVI 007 | Percent change from baseline in PCSK9 | Posted | Median | Full Range | percentage change from baseline | Baseline, D29, D57, D85 |
|
Approximately 31 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 | CIVI 007, Dose A | Subcutaneous (SC) injection of a PCSK9 inhibitor- low dose given twice CIVI 007: hypercholesterolemia agent |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alanine aminotransferase increased | Investigations | MedDRA 22.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alanine aminotransferase increased | Investigations | MedDRA 22.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief, Clinical Development | CiVi Biopharma, Inc. | 484-674-5456 | chuck.shear@civibiopharma.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 | Nov 14, 2019 | Jan 19, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 19, 2020 | Jan 19, 2025 | 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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| Baseline through 2 month follow-up |
| Port Orange |
| Florida |
| 32127 |
| United States |
| Research Site | Indianapolis | Indiana | 46260 | United States |
| Research Site | Louisville | Kentucky | 40213 | United States |
| Research Site | Cincinnati | Ohio | 45227 | United States |
| Research Site | Munroe Falls | Ohio | 44224 | United States |
| Research Site | San Antonio | Texas | 78229 | United States |
| BG002 | CIVI 007, Dose C | SC injection of PCSK9 inhibitor- high dose given twice CIVI 007: hypercholesterolemia agent |
| BG003 | Placebo | Placebo SC injection matching PCSK9 inhibitor given twice CIVI 007: hypercholesterolemia agent |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Childbearing potential, n | Number | participants |
|
| Height | Mean | Standard Deviation | cm |
|
| Weight | Mean | Standard Deviation | kg |
|
| Body mass index | Mean | Standard Deviation | kg/m2 |
|
| Body mass index category | Count of Participants | Participants |
|
| PCSK9 | Mean | Standard Deviation | ug/L |
|
| Fasting LDL-C | Mean | Standard Deviation | mg/dL |
|
| Taking lower than recommended statin therapy? | Count of Participants | Participants |
|
| Background statin therapy | Count of Participants | Participants |
|
| Ezetimibe use | Count of Participants | Participants |
|
| OG003 | Experimental: CIVI 007, Dose C | SC injection of PCSK9 inhibitor- high dose given twice |
|
|
|
| Secondary | Assessment of the Lipid Efficacy of CIVI 007 | Percent change from baseline in LDL-C | Posted | Median | Full Range | percentage change from baseline | Baseline, Day 29, Day 57, Day 85 |
|
|
|
|
| Secondary | Assessment of CIVI 007 Adverse Events (AEs) | Incidence of any drug-related AEs | Posted | Count of Participants | Participants | Baseline through 2 month follow-up |
|
|
|
| 0 |
| 12 |
| 1 |
| 12 |
| 8 |
| 12 |
| EG001 | CIVI 007, Dose B | SC injection of PCSK9 inhibitor- dose titration CIVI 007: hypercholesterolemia agent | 0 | 13 | 0 | 13 | 10 | 13 |
| EG002 | CIVI 007, Dose C | SC injection of PCSK9 inhibitor- high dose given twice CIVI 007: hypercholesterolemia agent | 0 | 12 | 0 | 12 | 6 | 12 |
| EG003 | Placebo | Placebo SC injection matching PCSK9 inhibitor given twice CIVI 007: hypercholesterolemia agent | 0 | 12 | 0 | 12 | 9 | 12 |
| Aspartate aminotransferase increased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 22.0 | Non-systematic Assessment |
|
| Transaminases increased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Crystal urine present | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Glomerular filtration rate decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Protein total increased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Urine analysis abnormal | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Urine protein/creatinine ratio increased | Investigations | MedDRA 22.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Injection site induration | General disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Gingival pain | Gastrointestinal disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Albuminuria | Renal and urinary disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Thrombocytosis | Blood and lymphatic system disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 22.0 | Non-systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 22.0 | Non-systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 22.0 | Non-systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Eye inflammation | Eye disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Ageusia | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Anosmia | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
|
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| D009750 |
| Nutritional and Metabolic Diseases |
| Day 57 |
|
| Day 85 |
|
Similar changes from baseline were observed for Day 29, Day 57, and Day 85 compared to Day 29, Day 57, and Day 85 LOCF. |
| ANCOVA |
ANCOVA with LOCF |
| <0.0001 |
| Least Square Mean |
| -49.59 |
| Standard Error of the Mean |
| 7.396 |
| 2-Sided |
| 95 |
| -64.50 |
| 34.69 |
| Superiority |
| Similar changes from baseline were observed for Day 29, Day 57, and Day 85 compared to Day 29, Day 57, and Day 85 LOCF. | ANCOVA | ANCOVA with LOCF | <0.0001 | Least Square Mean | -51.99 | Standard Error of the Mean | 7.616 | 2-Sided | 95 | -67.34 | -36.64 | Superiority |
| Moderate |
|
| Severe |
|