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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-000411-32 | EudraCT Number |
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This is an open-label, single-arm study to assess the reduction of low-density lipoprotein cholesterol (LDL-C) by REGN1500 in patients with homozygous familial hypercholesterolemia (HoFH).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open-label | Experimental | Open-label REGN1500 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Drug | Participants received single dose of REGN1500 subcutaneous (SC) injection of 250 milligrams (mg) at Week 0 (Day 1), followed by single dose of REGN1500 intravenous (IV) injection of 15 milligrams per kilogram (mg/kg) at Week 2 (Day 15) and then followed by 4 doses of REGN1500 SC injection of 450 mg once weekly starting from Week 12 (Day 85). Only the first 2 enrolled participants received 4 weekly REGN1500 450 mg SC doses at weeks 12, 13, 14, and 15 per the protocol. This dose regimen was removed under protocol amendment 4. Participants were followed for a period of 24 weeks (through Week 26 [Day 183]) after the last dose of study drug in the main study period. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) to Week 4 in the Main Study Period | Percent change was reported for low-density lipoprotein cholesterol (LDL-C) from baseline (week 0) up to week 4. LDL-C was measured using conventional units mg/dL. The efficacy analysis set included all participants in the safety analysis set (SAF) who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period. | Baseline (Week 0) up to Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) to Week 4 in the Main Study Period | Absolute change in low-density lipoprotein cholesterol (LDL-C) from baseline (week 0) up to week 4 was reported. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period. | Baseline (Week 0) up to Week 4 |
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Inclusion Criteria:
Exclusion Criteria:
Note: The information listed above is not intended to contain all considerations relevant to a patient's potential participation in this clinical trial therefore not all inclusion/ exclusion criteria are listed.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles | California | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28723334 | Background | Gaudet D, Gipe DA, Pordy R, Ahmad Z, Cuchel M, Shah PK, Chyu KY, Sasiela WJ, Chan KC, Brisson D, Khoury E, Banerjee P, Gusarova V, Gromada J, Stahl N, Yancopoulos GD, Hovingh GK. ANGPTL3 Inhibition in Homozygous Familial Hypercholesterolemia. N Engl J Med. 2017 Jul 20;377(3):296-297. doi: 10.1056/NEJMc1705994. No abstract available. | |
| 31578082 |
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This study consisted of 2 screening periods: 1st for main study and 2nd for open label extension (OLE) period. Participants on stable background medical lipid-modifying therapy for at least 4 weeks prior to screening, or who didn't undergo lipid apheresis within 4 weeks prior to screening visit, were directly entered into a 2-week screening period.
The study was conducted at five sites in United States, Canada, and the Netherlands between 04 Feb 2015 and 23 Jul 2018. A total of 12 participants were screened in the study. Out of 12 participants, 9 participants received the study treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Participants received single dose of REGN1500 subcutaneous (SC) injection of 250 milligrams (mg) at Week 0 (Day 1), followed by single dose of REGN1500 intravenous (IV) injection of 15 milligrams per kilogram (mg/kg) at Week 2 (Day 15) and then followed by 4 doses of REGN1500 SC injection of 450 mg once weekly starting from Week 12 (Day 85). Only the first 2 enrolled participants received 4 weekly REGN1500 450 mg SC doses at weeks 12, 13, 14, and 15 per the protocol. This dose regimen was removed under protocol amendment 4. Participants were followed for a period of 24 weeks (through Week 26 [Day 183]) after the last dose of study drug in the main study period. |
| FG001 | REGN1500 300 mg SC/20 mg/kg IV | Participants received REGN1500 SC injection of 300 mg at Week 26 (Day 183), 27(Day 190), 28 (Day 197) and 29 (Day 204) followed by IV injection of 20 mg/kg at Week 38 (Day 267) and every 12 weeks starting at Week 58 (Day 407) through Week 178 (Day 1247) in open-label extension period. Participants were to be followed for a period of 24 weeks (through Week 214 [Day 1499]) after the last dose of study drug in the OLE treatment period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Main Study Period |
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| Open Label Extension (OLE) Period |
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| ID | Title | Description |
|---|---|---|
| BG000 | REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Participants received single dose of REGN1500 subcutaneous (SC) injection of 250 milligrams (mg) at Week 0 (Day 1), followed by single dose of REGN1500 intravenous (IV) injection of 15 milligrams per kilogram (mg/kg) at Week 2 (Day 15) and then followed by 4 doses of REGN1500 SC injection of 450 mg once weekly starting from Week 12 (Day 85). Only the first 2 enrolled participants received 4 weekly REGN1500 450 mg SC doses at weeks 12, 13, 14, and 15 per the protocol. This dose regimen was removed under protocol amendment 4. Participants were followed for a period of 24 weeks (through Week 26 [Day 183]) after the last dose of study drug in the main study period. |
| Units | Counts |
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| Participants |
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| 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 | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) to Week 4 in the Main Study Period | Absolute change in low-density lipoprotein cholesterol (LDL-C) from baseline (week 0) up to week 4 was reported. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period. | Posted | Mean | Standard Deviation | mg/dL | Baseline (Week 0) up to Week 4 |
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All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
During the main study period, the safety analysis set (SAF) was defined as all enrolled participants who received at least 1 dose or part of a dose. For OLE, the SAF was defined as all enrolled participants who received at least 1 dose or part of a dose in the OLE period. The SAF in both study periods was based on the treatment received (as treated).
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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 | Main Study Period: REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Participants received single dose of REGN1500 subcutaneous (SC) injection of 250 milligrams (mg) at Week 0 (Day 1), followed by single dose of REGN1500 intravenous (IV) injection of 15 milligrams per kilogram (mg/kg) at Week 2 (Day 15) and then followed by 4 doses of REGN1500 SC injection of 450 mg once weekly starting from Week 12 (Day 85). Only the first 2 enrolled participants received 4 weekly REGN1500 450 mg SC doses at weeks 12, 13, 14, and 15 per the protocol. This dose regimen was removed under protocol amendment 4. Participants were followed for a period of 24 weeks (through Week 26 [Day 183]) after the last dose of study drug in the main study period. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary artery disease | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
At the time patients completed the main study, the open-label extension (OLE) study was not yet open to enrollment. Therefore, there was a lag of between 168 days to 586 days between the end of the main study and the start of the OLE study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Information | Regeneron Pharmaceuticals, Inc. | 844-734-6643 | clinicaltrials@regeneron.com |
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| ID | Term |
|---|---|
| D000090542 | Homozygous Familial Hypercholesterolemia |
| ID | Term |
|---|---|
| D006938 | Hyperlipoproteinemia Type II |
| D008052 | Lipid Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
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| ID | Term |
|---|---|
| C000621590 | evinacumab |
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| Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Week 2 to Week 4 in the Main Study Period | Absolute change in low-density lipoprotein cholesterol (LDL-C) from week 2 to week 4 was reported. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period. | Week 2 to Week 4 |
| Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Week 2 to Week 4 in the Main Study Period | Percent change was reported in low-density lipoprotein cholesterol (LDL-C) from week 2 to week 4. LDL-C was measured using conventional units mg/dL. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period. | Week 2 to Week 4 |
| Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period | Absolute change was reported in low-density lipoprotein cholesterol (LDL-C) from baseline (week 0) up to week 26. The efficacy analysis set included all participants in the safety analysis set (SAF) who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period. | Baseline (Week 0) up to Week 26 |
| Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period | Percent change was reported in low-density lipoprotein cholesterol (LDL-C) from baseline (week 0) up to week 26. LDL-C was measured using conventional units mg/dL. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period. | Baseline (Week 0) up to Week 26 |
| Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Absolute change in low-density lipoprotein cholesterol (LDL-C) from baseline (week 26) up to week 214 was reported. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period. (ET= Early Termination; EOS = End of Study) | Baseline (Week 26) up to Week 214 |
| Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Percent change was reported in low-density lipoprotein cholesterol (LDL-C) from baseline (week 26) to week 214 in the OLE period. LDL-C was measured using conventional units mg/dL. The efficacy analysis set included all participants in the SAF who had at least 1 post-baseline measure of the lipid panel in the main study period. (ET= Early Termination; EOS = End of Study) | Baseline (Week 26) up to Week 214 |
| Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Absolute change was reported for Apo B, Non-HDL-C, Total-C, and Lp(a) from baseline (week 0) up to Week 26. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period. | Baseline (Week 0) up to Week 26 |
| Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Percent change was reported for Apo B, Non-HDL-C, Total-C, and Lp(a) from baseline (week 0) up to week 26. Apo B, Non-HDL-C, Total-C, and Lp(a) were measured using conventional units mg/dL. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period. | Baseline (Week 0) up to Week 26 |
| Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Absolute changein Apo B, Non-HDL-C, Total-C, and Lp(a) from baseline to week 214 in open label extension (OLE) period. The efficacy analysis set included all participants in the SAF who had baseline and at least one post-baseline measure of the lipid panel in the main study period. (ET = Early Termination; EOS = End of Study) | Baseline (Week 26) up to Week 214 |
| Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Percent change was reported in Apo B, Non-HDL-C, Total-C, and Lp(a) from baseline (week 26) up to week 214 in OLE Period. Apo B, Non-HDL-C, Total-C, and Lp(a) were measured using conventional units mg/dL. The efficacy analysis set included all participants in the SAF who had baseline and at least one post-baseline measure of the lipid panel in the main study period. (ET= Early Termination; EOS = End of Study) | Baseline (Week 26) up to Week 214 |
| Percentage of Participants Who Achieved Reduction in Low-Density Lipoprotein Cholesterol (LDL-C) of ≥ 25% From Baseline (Week 0) in the Main Study Period | Percentage of participants who achieved reduction in low-density lipoprotein cholesterol (LDL-C) of greater than or equal to (≥) 25 percent (%) from baseline in the main study period was reported. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period. | Baseline (Week 0) up to Week 26 |
| Percentage of Participants Who Achieved Reduction in Low-Density Lipoprotein Cholesterol (LDL-C) of ≥ 25% From Baseline (Week 26) in the Open Label Extension (OLE) Period | Percentage of participants who achieved a reduction in low-density lipoprotein cholesterol (LDL-C) of ≥ 25% from baseline (week 26) to week 214 was reported. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period. | Baseline (Week 26) to Week 214 |
| Percentage of Participants Who Achieved Reduction in Low-Density Lipoprotein Cholesterol (LDL-C) of ≥ 50% From Baseline (Week 0) in the Main Study Period | Percentage of participants who achieved a reduction in low-density lipoprotein cholesterol (LDL-C) of ≥ 50% from baseline (week 0) to week 26 was reported. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period. | Baseline (Week 0) to Week 26 |
| Percentage of Participants Who Achieved Reduction in Low-Density Lipoprotein Cholesterol (LDL-C) of ≥ 50% From Baseline (Week 26) in the Open Label Extension (OLE) Period | Percentage of participants who achieved reduction in low-density lipoprotein cholesterol (LDL-C) of ≥ 50% from baseline (week 26) in the OLE period was reported. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period. | Baseline (Week 26) up to Week 214 |
| Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | Absolute change was reported in HDL-C, TG, and Apo A-1 from baseline (week 0) up to week 26. The efficacy analysis set included all participants in the SAF who had baseline and at least one post-baseline measure of the lipid panel in the main study period. | Baseline (Week 0) up to Week 26 |
| Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | Percent change was reported in HDL-C, TG, and Apo A-1 from baseline (week 0) up to week 26. HDL-C, TG, and Apo A-1 were measured using conventional units mg/dL. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period. | Baseline (Week 0) up to Week 26 |
| Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Percent change was reported in HDL-C, TG and Apo A-1 from baseline (week 26) up to week 214. HDL-C, TG and Apo A-1 were measured using conventional units mg/dL. The efficacy analysis set included all participants in the SAF who had baseline and at least one post-baseline measure of the lipid panel in the main study period. (ET= Early Termination; EOS = End of Study) | Baseline (Week 26) up to Week 214 |
| Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Absolute change was reported in HDL-C, TG and Apo A-1 from baseline (week 26) up to week 214. The efficacy analysis set included all participants in the SAF who had baseline and at least one post-baseline measure of the lipid panel in the main study period. (ET= Early Termination; EOS = End of Study) | Baseline (Week 26) up to Week 214 |
| Absolute Change in Apolipoprotein CIII (Apo CIII) From Baseline (Week 0) Over Time in the Main Study Period | Absolute change was reported in Apo CIII from baseline (week 0) up to week 16. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period. | Baseline (Week 0) up to Week 16 |
| Percent Change in Apolipoprotein CIII (Apo CIII) From Baseline (Week 0) Over Time in the Main Study Period | Percent change was reported in Apo CIII from baseline (week 0) up to week 16. Apo CIII was measured using conventional units mg/dL. The efficacy analysis set included all participants in the SAF who had baseline and at least one post-baseline measure of the lipid panel in the main study period. | Baseline (Week 0) to Week 16 |
| Philadelphia |
| Pennsylvania |
| United States |
| Dallas | Texas | United States |
| Chicoutimi | Quebec | Canada |
| Amsterdam | Netherlands |
| Banerjee P, Chan KC, Tarabocchia M, Benito-Vicente A, Alves AC, Uribe KB, Bourbon M, Skiba PJ, Pordy R, Gipe DA, Gaudet D, Martin C. Functional Analysis of LDLR (Low-Density Lipoprotein Receptor) Variants in Patient Lymphocytes to Assess the Effect of Evinacumab in Homozygous Familial Hypercholesterolemia Patients With a Spectrum of LDLR Activity. Arterioscler Thromb Vasc Biol. 2019 Nov;39(11):2248-2260. doi: 10.1161/ATVBAHA.119.313051. Epub 2019 Oct 3. |
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| Age, Customized | Number | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity | Count of Participants | Participants |
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| Race | Count of Participants | Participants |
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| Baseline Low-Density Lipoprotein Cholesterol (LDL-C) | Mean | Standard Deviation | Milligram per Deciliter (mg/dL) |
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| Baseline High-Density Lipoprotein Cholesterol (HDL-C) | Mean | Standard Deviation | mg/dL |
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| Baseline Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) | Mean | Standard Deviation | mg/dL |
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| Baseline Apolipoprotein B (Apo B) | Mean | Standard Deviation | mg/dL |
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| Baseline Apolipoprotein CIII (Apo CIII) | Mean | Standard Deviation | mg/dL |
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| Baseline Triglyceride (TG) | Mean | Standard Deviation | mg/dL |
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| Baseline Lipoprotein(a) (Lp[a]) | Mean | Standard Deviation | mg/dL |
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| Baseline Total Cholesterol (Total -C) | Mean | Standard Deviation | mg/dL |
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| Baseline Apolipoprotein A-1 (Apo A-1) | Mean | Standard Deviation | mg/dL |
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| Primary | Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) to Week 4 in the Main Study Period | Percent change was reported for low-density lipoprotein cholesterol (LDL-C) from baseline (week 0) up to week 4. LDL-C was measured using conventional units mg/dL. The efficacy analysis set included all participants in the safety analysis set (SAF) who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period. | Posted | Mean | Standard Deviation | Percent Change | Baseline (Week 0) up to Week 4 |
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| Secondary | Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Week 2 to Week 4 in the Main Study Period | Absolute change in low-density lipoprotein cholesterol (LDL-C) from week 2 to week 4 was reported. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period. | Posted | Mean | Standard Deviation | Milligram per Deciliter (mg/dL) | Week 2 to Week 4 |
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| Secondary | Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Week 2 to Week 4 in the Main Study Period | Percent change was reported in low-density lipoprotein cholesterol (LDL-C) from week 2 to week 4. LDL-C was measured using conventional units mg/dL. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period. | Posted | Mean | Standard Deviation | Percent Change | Week 2 to Week 4 |
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| Secondary | Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period | Absolute change was reported in low-density lipoprotein cholesterol (LDL-C) from baseline (week 0) up to week 26. The efficacy analysis set included all participants in the safety analysis set (SAF) who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period. | "n" = Number of participants who were evaluable for this endpoint at a given time point. | Posted | Mean | Standard Deviation | mg/dL | Baseline (Week 0) up to Week 26 |
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| Secondary | Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period | Percent change was reported in low-density lipoprotein cholesterol (LDL-C) from baseline (week 0) up to week 26. LDL-C was measured using conventional units mg/dL. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period. | "n" = Number of participants who were evaluable for this endpoint at a given time point. | Posted | Mean | Standard Deviation | Percent Change | Baseline (Week 0) up to Week 26 |
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| Secondary | Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Absolute change in low-density lipoprotein cholesterol (LDL-C) from baseline (week 26) up to week 214 was reported. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period. (ET= Early Termination; EOS = End of Study) | "n" = Number of participants who were evaluable for this endpoint at a given time point. | Posted | Mean | Standard Deviation | mg/dL | Baseline (Week 26) up to Week 214 |
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| Secondary | Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Percent change was reported in low-density lipoprotein cholesterol (LDL-C) from baseline (week 26) to week 214 in the OLE period. LDL-C was measured using conventional units mg/dL. The efficacy analysis set included all participants in the SAF who had at least 1 post-baseline measure of the lipid panel in the main study period. (ET= Early Termination; EOS = End of Study) | "n" = Number of participants who were evaluable for this endpoint at a given time point. | Posted | Mean | Standard Deviation | Percent Change | Baseline (Week 26) up to Week 214 |
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| Secondary | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Absolute change was reported for Apo B, Non-HDL-C, Total-C, and Lp(a) from baseline (week 0) up to Week 26. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period. | "n" = Number of participants who were evaluable for this endpoint at a given time point. | Posted | Mean | Standard Deviation | mg/dL | Baseline (Week 0) up to Week 26 |
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| Secondary | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Percent change was reported for Apo B, Non-HDL-C, Total-C, and Lp(a) from baseline (week 0) up to week 26. Apo B, Non-HDL-C, Total-C, and Lp(a) were measured using conventional units mg/dL. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period. | "n" = Number of participants who were evaluable for this endpoint at a given time point. | Posted | Mean | Standard Deviation | Percent Change | Baseline (Week 0) up to Week 26 |
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| Secondary | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Absolute changein Apo B, Non-HDL-C, Total-C, and Lp(a) from baseline to week 214 in open label extension (OLE) period. The efficacy analysis set included all participants in the SAF who had baseline and at least one post-baseline measure of the lipid panel in the main study period. (ET = Early Termination; EOS = End of Study) | "n" = Number of participants who were evaluable for this endpoint at a given time point. | Posted | Mean | Standard Deviation | mg/dL | Baseline (Week 26) up to Week 214 |
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| Secondary | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Percent change was reported in Apo B, Non-HDL-C, Total-C, and Lp(a) from baseline (week 26) up to week 214 in OLE Period. Apo B, Non-HDL-C, Total-C, and Lp(a) were measured using conventional units mg/dL. The efficacy analysis set included all participants in the SAF who had baseline and at least one post-baseline measure of the lipid panel in the main study period. (ET= Early Termination; EOS = End of Study) | "n" = Number of participants who were evaluable for this endpoint at a given time point. | Posted | Mean | Standard Deviation | Percent change | Baseline (Week 26) up to Week 214 |
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| Secondary | Percentage of Participants Who Achieved Reduction in Low-Density Lipoprotein Cholesterol (LDL-C) of ≥ 25% From Baseline (Week 0) in the Main Study Period | Percentage of participants who achieved reduction in low-density lipoprotein cholesterol (LDL-C) of greater than or equal to (≥) 25 percent (%) from baseline in the main study period was reported. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period. | Posted | Number | Percentage of participants | Baseline (Week 0) up to Week 26 |
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| Secondary | Percentage of Participants Who Achieved Reduction in Low-Density Lipoprotein Cholesterol (LDL-C) of ≥ 25% From Baseline (Week 26) in the Open Label Extension (OLE) Period | Percentage of participants who achieved a reduction in low-density lipoprotein cholesterol (LDL-C) of ≥ 25% from baseline (week 26) to week 214 was reported. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period. | Posted | Number | Percentage of participants | Baseline (Week 26) to Week 214 |
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| Secondary | Percentage of Participants Who Achieved Reduction in Low-Density Lipoprotein Cholesterol (LDL-C) of ≥ 50% From Baseline (Week 0) in the Main Study Period | Percentage of participants who achieved a reduction in low-density lipoprotein cholesterol (LDL-C) of ≥ 50% from baseline (week 0) to week 26 was reported. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period. | Posted | Number | Percentage of participants | Baseline (Week 0) to Week 26 |
|
|
|
| Secondary | Percentage of Participants Who Achieved Reduction in Low-Density Lipoprotein Cholesterol (LDL-C) of ≥ 50% From Baseline (Week 26) in the Open Label Extension (OLE) Period | Percentage of participants who achieved reduction in low-density lipoprotein cholesterol (LDL-C) of ≥ 50% from baseline (week 26) in the OLE period was reported. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period. | Posted | Number | Percentage | Baseline (Week 26) up to Week 214 |
|
|
|
| Secondary | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | Absolute change was reported in HDL-C, TG, and Apo A-1 from baseline (week 0) up to week 26. The efficacy analysis set included all participants in the SAF who had baseline and at least one post-baseline measure of the lipid panel in the main study period. | "n" = Number of participants who were evaluable for this endpoint at a given time point. | Posted | Mean | Standard Deviation | mg/dL | Baseline (Week 0) up to Week 26 |
|
|
|
| Secondary | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | Percent change was reported in HDL-C, TG, and Apo A-1 from baseline (week 0) up to week 26. HDL-C, TG, and Apo A-1 were measured using conventional units mg/dL. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period. | "n" = Number of participants who were evaluable for this endpoint at a given time point. | Posted | Mean | Standard Deviation | Percent Change | Baseline (Week 0) up to Week 26 |
|
|
|
| Secondary | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Percent change was reported in HDL-C, TG and Apo A-1 from baseline (week 26) up to week 214. HDL-C, TG and Apo A-1 were measured using conventional units mg/dL. The efficacy analysis set included all participants in the SAF who had baseline and at least one post-baseline measure of the lipid panel in the main study period. (ET= Early Termination; EOS = End of Study) | "n" = Number of participants who were evaluable for this endpoint at a given time point. | Posted | Mean | Standard Deviation | Percent change | Baseline (Week 26) up to Week 214 |
|
|
|
| Secondary | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Absolute change was reported in HDL-C, TG and Apo A-1 from baseline (week 26) up to week 214. The efficacy analysis set included all participants in the SAF who had baseline and at least one post-baseline measure of the lipid panel in the main study period. (ET= Early Termination; EOS = End of Study) | "n" = Number of participants who were evaluable for this endpoint at a given time point. | Posted | Mean | Standard Deviation | mg/dL | Baseline (Week 26) up to Week 214 |
|
|
|
| Secondary | Absolute Change in Apolipoprotein CIII (Apo CIII) From Baseline (Week 0) Over Time in the Main Study Period | Absolute change was reported in Apo CIII from baseline (week 0) up to week 16. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period. | "n" = Number of participants who were evaluable for this endpoint at a given time point. | Posted | Mean | Standard Deviation | mg/dL | Baseline (Week 0) up to Week 16 |
|
|
|
| Secondary | Percent Change in Apolipoprotein CIII (Apo CIII) From Baseline (Week 0) Over Time in the Main Study Period | Percent change was reported in Apo CIII from baseline (week 0) up to week 16. Apo CIII was measured using conventional units mg/dL. The efficacy analysis set included all participants in the SAF who had baseline and at least one post-baseline measure of the lipid panel in the main study period. | "n" = Number of participants who were evaluable for this endpoint at a given time point. | Posted | Mean | Standard Deviation | Percent Change | Baseline (Week 0) to Week 16 |
|
|
|
| 0 |
| 9 |
| 1 |
| 9 |
| 9 |
| 9 |
| EG001 | OLE Period: REGN1500 300 mg SC/20 mg/kg IV | Participants received REGN1500 a SC injection of 300 mg at Week 26 (Day 183), 27(Day 190), 28 (Day 197) and 29 (Day 204) followed by IV injection of 20 mg/kg at Week 38 (Day 267) and every 12 weeks starting at Week 58 (Day 407) through Week 178 (Day 1247) in open-label extension period. Participants were to be followed for a period of 24 weeks (through Week 214 [Day 1499]) after the last dose of study drug in the OLE treatment period. | 0 | 8 | 2 | 8 | 8 | 8 |
| Coronary artery stenosis | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
|
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Corneal opacity | Eye disorders | MedDRA 17.0 | Systematic Assessment |
|
| Eye inflammation | Eye disorders | MedDRA 17.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Faeces discoloured | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Injection site haematoma | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Injection site haemorrhage | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Local swelling | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Food allergy | Immune system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Crush injury | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
|
| Procedural hypotension | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Crystal urine present | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Transaminases increased | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Memory impairment | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
|
| Renal failure chronic | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
|
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Rhinalgia | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Upper-Airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Generalised erythema | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Pruritus allergic | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
|
The investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006951 | Hyperlipoproteinemias |
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
|
| Change at Week 2 (n= 9) |
|
|
| Change at Week 3 (n= 9) |
|
|
| Change at Week 4 (n= 9) |
|
|
| Change at Week 5 (n= 8) |
|
|
| Change at Week 6 (n= 9) |
|
|
| Change at Week 8 (n= 9) |
|
|
| Change at Week 10 (n= 9) |
|
|
| Change at Week 12 (n= 9) |
|
|
| Change at Week 13 (n= 2) |
|
|
| Change at Week 14 (n= 9) |
|
|
| Change at Week 15 (n= 2) |
|
|
| Change at Week 16 (n= 9) |
|
|
| Change at Week 17 (n= 2) |
|
|
| Change at Week 18 (n= 7) |
|
|
| Change at Week 20 (n= 2) |
|
|
| Change at Week 22 (n= 7) |
|
|
| Change at Week 23 (n= 2) |
|
|
| Change at Week 25 (n= 2) |
|
|
| Change at Week 26 (n= 6) |
|
|
|
| Percent change at Week 2 (n= 9) |
|
|
| Percent change at Week 3 (n= 9) |
|
|
| Percent change at Week 4 (n= 9) |
|
|
| Percent change at Week 5 (n= 8) |
|
|
| Percent change at Week 6 (n= 9) |
|
|
| Percent change at Week 8 (n= 9) |
|
|
| Percent change at Week 10 (n= 9) |
|
|
| Percent change at Week 12 (n= 9) |
|
|
| Percent change at Week 13 (n= 2) |
|
|
| Percent change at Week 14 (n= 9) |
|
|
| Percent change at Week 15 (n= 2) |
|
|
| Percent change at Week 16 (n= 9) |
|
|
| Percent change at Week 17 (n= 2) |
|
|
| Percent change at Week 18 (n= 7) |
|
|
| Percent change at Week 20 (n= 2) |
|
|
| Percent change at Week 22 (n= 7) |
|
|
| Percent change at Week 23 (n= 2) |
|
|
| Percent change at Week 25 (n= 2) |
|
|
| Percent change at Week 26 (n= 6) |
|
|
|
| Change at Week 28 (n= 8) |
|
|
| Change at Week 29 (n= 8) |
|
|
| Change at Week 30 (n= 7) |
|
|
| Change at Week 31 (n= 8) |
|
|
| Change at Week 32 (n= 8) |
|
|
| Change at Week 34 (n= 8) |
|
|
| Change at Week 36 (n= 8) |
|
|
| Change at Week 38 (n= 8) |
|
|
| Change at Week 39 (n= 6) |
|
|
| Change at Week 40 (n= 6) |
|
|
| Change at Week 41 (n= 6) |
|
|
| Change at Week 42 (n= 6) |
|
|
| Change at Week 44 (n= 8) |
|
|
| Change at Week 46 (n= 8) |
|
|
| Change at Week 50 (n= 8) |
|
|
| Change at Week 54 (n= 8) |
|
|
| Change at Week 58 (n= 6) |
|
|
| Change at Week 70 (n= 4) |
|
|
| Change at Week 82 (n= 4) |
|
|
| Change at Week 94 (n= 1) |
|
|
| Change at Week 106 (n= 1) |
|
|
| Change at ET (n= 8) |
|
|
| Change at EOS (n= 3) |
|
|
|
| Percent change at Week 28 (n= 8) |
|
|
| Percent change at Week 29 (n= 8) |
|
|
| Percent change at Week 30 (n= 7) |
|
|
| Percent change at Week 31 (n= 8) |
|
|
| Percent change at Week 32 (n= 8) |
|
|
| Percent change at Week 34 (n= 8) |
|
|
| Percent change at Week 36 (n= 8) |
|
|
| Percent change at Week 38 (n= 8) |
|
|
| Percent change at Week 39 (n= 6) |
|
|
| Percent change at Week 40 (n= 6) |
|
|
| Percent change at Week 41 (n= 6) |
|
|
| Percent change at Week 42 (n= 6) |
|
|
| Percent change at Week 44 (n= 8) |
|
|
| Percent change at Week 46 (n= 8) |
|
|
| Percent change at Week 50 (n= 8) |
|
|
| Percent change at Week 54 (n= 8) |
|
|
| Percent change at Week 58 (n= 6) |
|
|
| Percent change at Week 70 (n= 4) |
|
|
| Percent change at Week 82 (n= 4) |
|
|
| Percent change at Week 94 (n= 1) |
|
|
| Percent change at Week 106 (n= 1) |
|
|
| Percent change at ET (n= 8) |
|
|
| Percent change at EOS (n= 3) |
|
|
|
| Apo B: Change at Week 4 (n = 9) |
|
|
| Apo B: Change at Week 5 (n = 8) |
|
|
| Apo B: Change at Week 6 (n = 9) |
|
|
| Apo B: Change at Week 8 (n = 9) |
|
|
| Apo B: Change at Week 12 (n = 9) |
|
|
| Apo B: Change at Week 14 (n = 9) |
|
|
| Apo B: Change at Week 16 (n = 9) |
|
|
| Apo B: Change at Week 18 (n = 7) |
|
|
| Apo B: Change at Week 20 (n = 2) |
|
|
| Apo B: Change at Week 22 (n = 7) |
|
|
| Apo B: Change at Week 23 (n = 2) |
|
|
| Apo B: Change at Week 26 (n = 6) |
|
|
| Non-HDL-C: Change at Day 4 (n = 9) |
|
|
| Non-HDL-C: Change at Week 1 (n = 9) |
|
|
| Non-HDL-C: Change at Week 2 (n = 9) |
|
|
| Non-HDL-C: Change at Week 3 (n = 9) |
|
|
| Non-HDL-C: Change at Week 4 (n = 9) |
|
|
| Non-HDL-C: Change at Week 5 (n = 8) |
|
|
| Non-HDL-C: Change at Week 6 (n = 9) |
|
|
| Non-HDL-C: Change at Week 8 (n = 9) |
|
|
| Non-HDL-C: Change at Week 10 (n = 9) |
|
|
| Non-HDL-C: Change at Week 12 (n = 9) |
|
|
| Non-HDL-C: Change at Week 13 (n = 2) |
|
|
| Non-HDL-C: Change at Week 14 (n = 9) |
|
|
| Non-HDL-C: Change at Week 15 (n = 2) |
|
|
| Non-HDL-C: Change at Week 16 (n = 9) |
|
|
| Non-HDL-C: Change at Week 17 (n = 2) |
|
|
| Non-HDL-C: Change at Week 18 (n = 7) |
|
|
| Non-HDL-C: Change at Week 20 (n = 2) |
|
|
| Non-HDL-C: Change at Week 22 (n = 7) |
|
|
| Non-HDL-C: Change at Week 23 (n = 2) |
|
|
| Non-HDL-C: Change at Week 25 (n = 2) |
|
|
| Non-HDL-C: Change at Week 26 (n = 6) |
|
|
| Total-C: Change at Day 4 (n = 9) |
|
|
| Total-C: Change at Week 1 (n = 9) |
|
|
| Total-C: Change at Week 2 (n = 9) |
|
|
| Total-C: Change at Week 3 (n = 9) |
|
|
| Total-C: Change at Week 4 (n = 9) |
|
|
| Total-C: Change at Week 5 (n = 8) |
|
|
| Total-C: Change at Week 6 (n = 9) |
|
|
| Total-C: Change at Week 8 (n = 9) |
|
|
| Total-C: Change at Week 10 (n = 9) |
|
|
| Total-C: Change at Week 12 (n = 9) |
|
|
| Total-C: Change at Week 13 (n = 2) |
|
|
| Total-C: Change at Week 14 (n = 9) |
|
|
| Total-C: Change at Week 15 (n = 2) |
|
|
| Total-C: Change at Week 16 (n = 9) |
|
|
| Total-C: Change at Week 17 (n = 2) |
|
|
| Total-C: Change at Week 18 (n = 7) |
|
|
| Total-C: Change at Week 20 (n = 2) |
|
|
| Total-C: Change at Week 22 (n = 7) |
|
|
| Total-C: Change at Week 23 (n = 2) |
|
|
| Total-C: Change at Week 25 (n = 2) |
|
|
| Total-C: Change at Week 26 (n = 6) |
|
|
| Lp(a): Change at Week 2 (n = 9) |
|
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| Lp(a): Change at Week 3 (n = 9) |
|
|
| Lp(a): Change at Week 4 (n = 9) |
|
|
| Lp(a): Change at Week 5 (n = 8) |
|
|
| Lp(a): Change at Week 6 (n = 9) |
|
|
| Lp(a): Change at Week 8 (n = 9) |
|
|
| Lp(a): Change at Week 12 (n = 9) |
|
|
| Lp(a): Change at Week 14 (n = 9) |
|
|
| Lp(a): Change at Week 16 (n = 9) |
|
|
| Lp(a): Change at Week 18 (n = 7) |
|
|
| Lp(a): Change at Week 20 (n = 2) |
|
|
| Lp(a): Change at Week 22 (n = 7) |
|
|
| Lp(a): Change at Week 23 (n = 2) |
|
|
| Lp(a): Change at Week 26 (n = 6) |
|
|
|
| Apo B: Percent change at Week 4 (n = 9) |
|
|
| Apo B: Percent change at Week 5 (n = 8) |
|
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| Apo B: Percent change at Week 6 (n = 9) |
|
|
| Apo B: Percent change at Week 8 (n = 9) |
|
|
| Apo B: Percent change at Week 12 (n = 9) |
|
|
| Apo B: Percent change at Week 14 (n = 9) |
|
|
| Apo B: Percent change at Week 16 (n = 9) |
|
|
| Apo B: Percent change at Week 18 (n = 7) |
|
|
| Apo B: Percent change at Week 20 (n = 2) |
|
|
| Apo B: Percent change at Week 22 (n = 7) |
|
|
| Apo B: Percent change at Week 23 (n = 2) |
|
|
| Apo B: Percent change at Week 26 (n = 6) |
|
|
| Non-HDL-C: Percent change at Day 4 (n = 9) |
|
|
| Non-HDL-C: Percent change at Week 1 (n = 9) |
|
|
| Non-HDL-C: Percent change at Week 2 (n = 9) |
|
|
| Non-HDL-C: Percent change at Week 3 (n = 9) |
|
|
| Non-HDL-C: Percent change at Week 4 (n = 9) |
|
|
| Non-HDL-C: Percent change at Week 5 (n = 8) |
|
|
| Non-HDL-C: Percent change at Week 6 (n = 9) |
|
|
| Non-HDL-C: Percent change at Week 8 (n = 9) |
|
|
| Non-HDL-C: Percent change at Week 10 (n = 9) |
|
|
| Non-HDL-C: Percent change at Week 12 (n = 9) |
|
|
| Non-HDL-C: Percent change at Week 13 (n = 2) |
|
|
| Non-HDL-C: Percent change at Week 14 (n = 9) |
|
|
| Non-HDL-C: Percent change at Week 15 (n = 2) |
|
|
| Non-HDL-C: Percent change at Week 16 (n = 9) |
|
|
| Non-HDL-C: Percent change at Week 17 (n = 2) |
|
|
| Non-HDL-C: Percent change at Week 18 (n = 7) |
|
|
| Non-HDL-C: Percent change at Week 20 (n = 2) |
|
|
| Non-HDL-C: Percent change at Week 22 (n = 7) |
|
|
| Non-HDL-C: Percent change at Week 23 (n = 2) |
|
|
| Non-HDL-C: Percent change at Week 25 (n = 2) |
|
|
| Non-HDL-C: Percent change at Week 26 (n = 6) |
|
|
| Total-C: Percent change at Day 4 (n = 9) |
|
|
| Total-C: Percent change at Week 1 (n = 9) |
|
|
| Total-C: Percent change at Week 2 (n = 9) |
|
|
| Total-C: Percent change at Week 3 (n = 9) |
|
|
| Total-C: Percent change at Week 4 (n = 9) |
|
|
| Total-C: Percent change at Week 5 (n = 8) |
|
|
| Total-C: Percent change at Week 6 (n = 9) |
|
|
| Total-C: Percent change at Week 8 (n = 9) |
|
|
| Total-C: Percent change at Week 10 (n = 9) |
|
|
| Total-C: Percent change at Week 12 (n = 9) |
|
|
| Total-C: Percent change at Week 13 (n = 2) |
|
|
| Total-C: Percent change at Week 14 (n = 9) |
|
|
| Total-C: Percent change at Week 15 (n = 2) |
|
|
| Total-C: Percent change at Week 16 (n = 9) |
|
|
| Total-C: Percent change at Week 17 (n = 2) |
|
|
| Total-C: Percent change at Week 18 (n = 7) |
|
|
| Total-C: Percent change at Week 20 (n = 2) |
|
|
| Total-C: Percent change at Week 22 (n = 7) |
|
|
| Total-C: Percent change at Week 23 (n = 2) |
|
|
| Total-C: Percent change at Week 25 (n = 2) |
|
|
| Total-C: Percent change at Week 26 (n = 6) |
|
|
| Lp(a): Percent change at Week 2 (n = 9) |
|
|
| Lp(a): Percent change at Week 3 (n = 9) |
|
|
| Lp(a): Percent change at Week 4 (n = 9) |
|
|
| Lp(a): Percent change at Week 5 (n = 8) |
|
|
| Lp(a): Percent change at Week 6 (n = 9) |
|
|
| Lp(a): Percent change at Week 8 (n = 9) |
|
|
| Lp(a): Percent change at Week 12 (n = 9) |
|
|
| Lp(a): Percent change at Week 14 (n = 9) |
|
|
| Lp(a): Percent change at Week 16 (n = 9) |
|
|
| Lp(a): Percent change at Week 18 (n = 7) |
|
|
| Lp(a): Percent change at Week 20 (n = 2) |
|
|
| Lp(a): Percent change at Week 22 (n = 7) |
|
|
| Lp(a): Percent change at Week 23 (n = 2) |
|
|
| Lp(a): Percent change at Week 26 (n = 6) |
|
|
|
| Apo B: Change at Week 38 (n= 8) |
|
|
| Apo B: Change at Week 42 (n= 6) |
|
|
| Apo B: Change at Week 44 (n= 8) |
|
|
| Apo B: Change at Week 50 (n= 8) |
|
|
| Apo B: Change at Week 70 (n= 4) |
|
|
| Apo B: Change at Week 82 (n= 4) |
|
|
| Apo B: Change at Week 94 (n= 1) |
|
|
| Apo B: Change at Week 106 (n= 1) |
|
|
| Apo B: Change at ET (n= 8) |
|
|
| Apo B: Change at EOS (n= 3) |
|
|
| Non- HDL-C: Change at Week 27 (n= 8) |
|
|
| Non- HDL-C: Change at Week 28 (n= 8) |
|
|
| Non- HDL-C: Change at Week 29 (n= 8) |
|
|
| Non- HDL-C: Change at Week 30 (n= 7) |
|
|
| Non- HDL-C: Change at Week 31 (n= 8) |
|
|
| Non- HDL-C: Change at Week 32 (n= 8) |
|
|
| Non- HDL-C: Change at Week 34 (n= 8) |
|
|
| Non- HDL-C: Change at Week 36 (n= 8) |
|
|
| Non- HDL-C: Change at Week 38 (n= 8) |
|
|
| Non- HDL-C: Change at Week 39 (n= 6) |
|
|
| Non- HDL-C: Change at Week 40 (n= 6) |
|
|
| Non- HDL-C: Change at Week 41 (n= 6) |
|
|
| Non- HDL-C:Change at Week 42 (n= 6) |
|
|
| Non- HDL-C: Change at Week 44 (n= 8) |
|
|
| Non- HDL-C: Change at Week 46 (n= 8) |
|
|
| Non- HDL-C: Change at Week 50 (n= 8) |
|
|
| Non- HDL-C: Change at Week 54 (n= 8) |
|
|
| Non- HDL-C: Change at Week 58 (n= 6) |
|
|
| Non- HDL-C: Change at Week 70 (n= 4) |
|
|
| Non- HDL-C: Change at Week 82 (n= 4) |
|
|
| Non- HDL-C: Change at Week 94 (n= 1) |
|
|
| Non- HDL-C: Change at Week 106 (n= 1) |
|
|
| Non- HDL-C: Change at ET (n= 8) |
|
|
| Non- HDL-C: Change at EOS (n= 3) |
|
|
| Total-C: Change at Week 27 (n= 8) |
|
|
| Total-C: Change at Week 28 (n= 8) |
|
|
| Total-C: Change at Week 29 (n= 8) |
|
|
| Total-C: Change at Week 30 (n= 7) |
|
|
| Total-C: Change at Week 31 (n= 8) |
|
|
| Total-C: Change at Week 32 (n= 8) |
|
|
| Total-C: Change at Week 34 (n= 8) |
|
|
| Total-C: Change at Week 36 (n= 8) |
|
|
| Total-C: Change at Week 38 (n= 8) |
|
|
| Total-C: Change at Week 39 (n= 6) |
|
|
| Total-C: Change at Week 40 (n= 6) |
|
|
| Total-C: Change at Week 41 (n= 6) |
|
|
| Total-C: Change at Week 42 (n= 6) |
|
|
| Total-C: Change at Week 44 (n= 8) |
|
|
| Total-C: Change at Week 46 (n= 8) |
|
|
| Total-C: Change at Week 50 (n= 8) |
|
|
| Total-C: Change at Week 54 (n= 8) |
|
|
| Total-C: Change at Week 58 (n= 6) |
|
|
| Total-C: Change at Week 70 (n= 4) |
|
|
| Total-C: Change at Week 82 (n= 4) |
|
|
| Total-C: Change at Week 94 (n= 1) |
|
|
| Total-C: Change at Week 106 (n= 1) |
|
|
| Total-C: Change at ET (n= 8) |
|
|
| Total-C: Change at EOS (n= 3) |
|
|
| Lp(a): Change at Week 30 (n= 7) |
|
|
| Lp(a): Change at Week 34 (n= 8) |
|
|
| Lp(a): Change at Week 38 (n= 8) |
|
|
| Lp(a): Change at Week 42 (n= 6) |
|
|
| Lp(a): Change at Week 44 (n= 8) |
|
|
| Lp(a): Change at Week 50 (n= 8) |
|
|
| Lp(a): Change at Week 70 (n= 4) |
|
|
| Lp(a): Change at Week 82 (n= 4) |
|
|
| Lp(a): Change at Week 94 (n= 1) |
|
|
| Lp(a): Change at Week 106 (n= 1) |
|
|
| Lp(a): Change at Week ET (n= 8) |
|
|
| Lp(a): Change at EOS (n= 3) |
|
|
|
| Apo B: Percent change at Week 38 (n= 8) |
|
|
| Apo B: Percent change at Week 42 (n= 6) |
|
|
| Apo B: Percent change at Week 44 (n= 8) |
|
|
| Apo B: Percent change at Week 50 (n= 8) |
|
|
| Apo B: Percent change at Week 70 (n= 4) |
|
|
| Apo B: Percent change at Week 82 (n= 4) |
|
|
| Apo B: Percent change at Week 94 (n= 1) |
|
|
| Apo B: Percent change at Week 106 (n= 1) |
|
|
| Apo B: Percent change at ET (n= 8) |
|
|
| Apo B: Percent change at EOS (n= 3) |
|
|
| Non- HDL-C: Percent change at Week 27 (n= 8) |
|
|
| Non- HDL-C: Percent change at Week 28 (n= 8) |
|
|
| Non- HDL-C: Percent change at Week 29 (n= 8) |
|
|
| Non- HDL-C: Percent change at Week 30 (n= 7) |
|
|
| Non- HDL-C: Percent change at Week 31 (n= 8) |
|
|
| Non- HDL-C: Percent change at Week 32 (n= 8) |
|
|
| Non- HDL-C: Percent change at Week 34 (n= 8) |
|
|
| Non- HDL-C: Percent change at Week 36 (n= 8) |
|
|
| Non- HDL-C: Percent change at Week 38 (n= 8) |
|
|
| Non- HDL-C: Percent change at Week 39 (n= 6) |
|
|
| Non- HDL-C: Percent change at Week 40 (n= 6) |
|
|
| Non- HDL-C: Percent change at Week 41 (n= 6) |
|
|
| Non- HDL-C: Percent change at Week 42 (n= 6) |
|
|
| Non- HDL-C: Percent change at Week 44 (n= 8) |
|
|
| Non- HDL-C: Percent change at Week 46 (n= 8) |
|
|
| Non- HDL-C: Percent change at Week 50 (n= 8) |
|
|
| Non- HDL-C: Percent change at Week 54 (n= 8) |
|
|
| Non- HDL-C: Percent change at Week 58 (n= 6) |
|
|
| Non- HDL-C: Percent change at Week 70 (n= 4) |
|
|
| Non- HDL-C: Percent change at Week 82 (n= 4) |
|
|
| Non- HDL-C: Percent change at Week 94 (n= 1) |
|
|
| Non- HDL-C: Percent change at Week 106 (n= 1) |
|
|
| Non- HDL-C: Percent change at ET (n= 8) |
|
|
| Non- HDL-C: Percent change at EOS (n= 3) |
|
|
| Total-C: Percent change at Week 27 (n= 8) |
|
|
| Total-C: Percent change at Week 28 (n= 8) |
|
|
| Total-C: Percent change at Week 29 (n= 8) |
|
|
| Total-C: Percent change at Week 30 (n= 7) |
|
|
| Total-C: Percent change at Week 31 (n= 8) |
|
|
| Total-C: Percent change at Week 32 (n= 8) |
|
|
| Total-C: Percent change at Week 34 (n= 8) |
|
|
| Total-C: Percent change at Week 36 (n= 8) |
|
|
| Total-C: Percent change at Week 38 (n= 8) |
|
|
| Total-C: Percent change at Week 39 (n= 6) |
|
|
| Total-C: Percent change at Week 40 (n= 6) |
|
|
| Total-C: Percent change at Week 41 (n= 6) |
|
|
| Total-C: Percent change at Week 42 (n= 6) |
|
|
| Total-C: Percent change at Week 44 (n= 8) |
|
|
| Total-C: Percent change at Week 46 (n= 8) |
|
|
| Total-C: Percent change at Week 50 (n= 8) |
|
|
| Total-C: Percent change at Week 54 (n= 8) |
|
|
| Total-C: Percent change at Week 58 (n= 6) |
|
|
| Total-C: Percent change at Week 70 (n= 4) |
|
|
| Total-C: Percent change at Week 82 (n= 4) |
|
|
| Total-C: Percent change at Week 94 (n= 1) |
|
|
| Total-C: Percent change at Week 106 (n= 1) |
|
|
| Total-C: Percent change at ET (n= 8) |
|
|
| Total-C: Percent change at EOS (n= 3) |
|
|
| Lp(a): Percent change at Week 30 (n= 7) |
|
|
| Lp(a): Percent change at Week 34 (n= 8) |
|
|
| Lp(a): Percent change at Week 38 (n= 8) |
|
|
| Lp(a): Percent change at Week 42 (n= 6) |
|
|
| Lp(a): Percent change at Week 44 (n= 8) |
|
|
| Lp(a): Percent change at Week 50 (n= 8) |
|
|
| Lp(a): Percent change at Week 70 (n= 4) |
|
|
| Lp(a): Percent change at Week 82 (n= 4) |
|
|
| Lp(a): Percent change at Week 94 (n= 1) |
|
|
| Lp(a): Percent change at Week 106 (n= 1) |
|
|
| Lp(a): Percent change at ET (n= 8) |
|
|
| Lp(a): Percent change at EOS (n= 3) |
|
|
|
| HDL-C: Change at Week 2 (n = 9) |
|
|
| HDL-C: Change at Week 3 (n = 9) |
|
|
| HDL-C: Change at Week 4 (n = 9) |
|
|
| HDL-C: Change at Week 5 (n = 8) |
|
|
| HDL-C: Change at Week 6 (n = 9) |
|
|
| HDL-C: Change at Week 8 (n = 9) |
|
|
| HDL-C: Change at Week 10 (n = 9) |
|
|
| HDL-C: Change at Week 12 (n = 9) |
|
|
| HDL-C: Change at Week 13 (n = 2) |
|
|
| HDL-C: Change at Week 14 (n = 9) |
|
|
| HDL-C: Change at Week 15 (n = 2) |
|
|
| HDL-C: Change at Week 16 (n = 9) |
|
|
| HDL-C: Change at Week 17 (n = 2) |
|
|
| HDL-C: Change at Week 18 (n = 7) |
|
|
| HDL-C: Change at Week 20 (n = 2) |
|
|
| HDL-C: Change at Week 22 (n = 7) |
|
|
| HDL-C: Change at Week 23 (n = 2) |
|
|
| HDL-C: Change at Week 25 (n = 2) |
|
|
| HDL-C: Change at Week 26 (n = 6) |
|
|
| TG: Change at Day 4 (n = 9) |
|
|
| TG: Change at Week 1 (n = 9) |
|
|
| TG: Change at Week 2 (n = 9) |
|
|
| TG: Change at Week 3 (n = 9) |
|
|
| TG: Change at Week 4 (n = 9) |
|
|
| TG: Change at Week 5 (n = 8) |
|
|
| TG: Change at Week 6 (n = 9) |
|
|
| TG: Change at Week 8 (n = 9) |
|
|
| TG: Change at Week 10 (n = 9) |
|
|
| TG: Change at Week 12 (n = 9) |
|
|
| TG: Change at Week 13 (n = 2) |
|
|
| TG: Change at Week 14 (n = 9) |
|
|
| TG: Change at Week 15 (n = 2) |
|
|
| TG: Change at Week 16 (n = 9) |
|
|
| TG: Change at Week 17 (n = 2) |
|
|
| TG: Change at Week 18 (n = 7) |
|
|
| TG: Change at Week 20 (n = 2) |
|
|
| TG: Change at Week 22 (n = 7) |
|
|
| TG: Change at Week 23 (n = 2) |
|
|
| TG: Change at Week 25 (n = 2) |
|
|
| TG: Change at Week 26 (n = 6) |
|
|
| Apo A-1: Change at Week 2 (n = 9) |
|
|
| Apo A-1: Change at Week 3 (n = 9) |
|
|
| Apo A-1: Change at Week 4 (n = 9) |
|
|
| Apo A-1: Change at Week 5 (n = 8) |
|
|
| Apo A-1: Change at Week 6 (n = 9) |
|
|
| Apo A-1: Change at Week 8 (n = 9) |
|
|
| Apo A-1: Change at Week 12 (n = 9) |
|
|
| Apo A-1: Change at Week 14 (n = 9) |
|
|
| Apo A-1: Change at Week 16 (n = 9) |
|
|
| Apo A-1: Change at Week 18 (n = 7) |
|
|
| Apo A-1: Change at Week 20 (n = 2) |
|
|
| Apo A-1: Change at Week 22 (n = 7) |
|
|
| Apo A-1: Change at Week 23 (n = 2) |
|
|
| Apo A-1: Change at Week 26 (n = 6) |
|
|
|
| HDL-C: Percent Change at Week 2 (n = 9) |
|
|
| HDL-C: Percent Change at Week 3 (n = 9) |
|
|
| HDL-C: Percent Change at Week 4 (n = 9) |
|
|
| HDL-C: Percent Change at Week 5 (n = 8) |
|
|
| HDL-C: Percent Change at Week 6 (n = 9) |
|
|
| HDL-C: Percent Change at Week 8 (n = 9) |
|
|
| HDL-C: Percent Change at Week 10 (n = 9) |
|
|
| HDL-C: Percent Change at Week 12 (n = 9) |
|
|
| HDL-C: Percent Change at Week 13 (n = 2) |
|
|
| HDL-C: Percent Change at Week 14 (n = 9) |
|
|
| HDL-C: Percent Change at Week 15 (n = 2) |
|
|
| HDL-C: Percent Change at Week 16 (n = 9) |
|
|
| HDL-C: Percent Change at Week 17 (n = 2) |
|
|
| HDL-C: Percent Change at Week 18 (n = 7) |
|
|
| HDL-C: Percent Change at Week 20 (n = 2) |
|
|
| HDL-C: Percent Change at Week 22 (n = 7) |
|
|
| HDL-C: Percent Change at Week 23 (n = 2) |
|
|
| HDL-C: Percent Change at Week 25 (n = 2) |
|
|
| HDL-C: Percent Change at Week 26 (n = 6) |
|
|
| TG: Percent Change at Day 4 (n = 9) |
|
|
| TG: Percent Change at Week 1 (n = 9) |
|
|
| TG: Percent Change at Week 2 (n = 9) |
|
|
| TG: Percent Change at Week 3 (n = 9) |
|
|
| TG: Percent Change at Week 4 (n = 9) |
|
|
| TG: Percent Change at Week 5 (n = 8) |
|
|
| TG: Percent Change at Week 6 (n = 9) |
|
|
| TG: Percent Change at Week 8 (n = 9) |
|
|
| TG: Percent Change at Week 10 (n = 9) |
|
|
| TG: Percent Change at Week 12 (n = 9) |
|
|
| TG: Percent Change at Week 13 (n = 2) |
|
|
| TG: Percent Change at Week 14 (n = 9) |
|
|
| TG: Percent Change at Week 15 (n = 2) |
|
|
| TG: Percent Change at Week 16 (n = 9) |
|
|
| TG: Percent Change at Week 17 (n = 2) |
|
|
| TG: Percent Change at Week 18 (n = 7) |
|
|
| TG: Percent Change at Week 20 (n = 2) |
|
|
| TG: Percent Change at Week 22 (n = 7) |
|
|
| TG: Percent Change at Week 23 (n = 2) |
|
|
| TG: Percent Change at Week 25 (n = 2) |
|
|
| TG: Percent Change at Week 26 (n = 6) |
|
|
| Apo A-1: Percent Change at Week 2 (n = 9) |
|
|
| Apo A-1: Percent Change at Week 3 (n = 9) |
|
|
| Apo A-1: Percent Change at Week 4 (n = 9) |
|
|
| Apo A-1: Percent Change at Week 5 (n = 8) |
|
|
| Apo A-1: Percent Change at Week 6 (n = 9) |
|
|
| Apo A-1: Percent Change at Week 8 (n = 9) |
|
|
| Apo A-1: Percent Change at Week 12 (n = 9) |
|
|
| Apo A-1: Percent Change at Week 14 (n = 9) |
|
|
| Apo A-1: Percent Change at Week 16 (n = 9) |
|
|
| Apo A-1: Percent Change at Week 18 (n = 7) |
|
|
| Apo A-1: Percent Change at Week 20 (n = 2) |
|
|
| Apo A-1: Percent Change at Week 22 (n = 7) |
|
|
| Apo A-1: Percent Change at Week 23 (n = 2) |
|
|
| Apo A-1: Percent Change at Week 26 (n = 6) |
|
|
|
| HDL-C: Percent change at Week 29 (n= 8) |
|
|
| HDL-C: Percent change at Week 30 (n= 7) |
|
|
| HDL-C: Percent change at Week 31 (n= 8) |
|
|
| HDL-C: Percent change at Week 32 (n= 8) |
|
|
| HDL-C: Percent change at Week 34 (n= 8) |
|
|
| HDL-C: Percent change at Week 36 (n= 8) |
|
|
| HDL-C: Percent change at Week 38 (n= 8) |
|
|
| HDL-C: Percent change at Week 39 (n= 6) |
|
|
| HDL-C: Percent change at Week 40 (n= 6) |
|
|
| HDL-C: Percent change at Week 41 (n= 6) |
|
|
| HDL-C: Percent change at Week 42 (n= 6) |
|
|
| HDL-C: Percent change at Week 44 (n= 8) |
|
|
| HDL-C: Percent change at Week 46 (n= 8) |
|
|
| HDL-C: Percent change at Week 50 (n= 8) |
|
|
| HDL-C: Percent change at Week 54 (n= 8) |
|
|
| HDL-C: Percent change at Week 58 (n= 6) |
|
|
| HDL-C: Percent change at Week 70 (n= 4) |
|
|
| HDL-C: Percent change at Week 82 (n= 4) |
|
|
| HDL-C: Percent change at Week 94 (n= 1) |
|
|
| HDL-C: Percent change at Week 106 (n= 1) |
|
|
| HDL-C: Percent change at ET (n= 8) |
|
|
| HDL-C: Percent change at EOS (n= 3) |
|
|
| Triglycerides: Percent change at Week 27 (n= 8) |
|
|
| Triglycerides: Percent change at Week 28 (n= 8) |
|
|
| Triglycerides: Percent change at Week 29 (n= 8) |
|
|
| Triglycerides: Percent change at Week 30 (n= 7) |
|
|
| Triglycerides: Percent change at Week 31 (n= 8) |
|
|
| Triglycerides: Percent change at Week 32 (n= 8) |
|
|
| Triglycerides: Percent change at Week 34 (n= 8) |
|
|
| Triglycerides: Percent change at Week 36 (n= 8) |
|
|
| Triglycerides: Percent change at Week 38 (n= 8) |
|
|
| Triglycerides: Percent change at Week 39 (n= 6) |
|
|
| Triglycerides: Percent change at Week 40 (n= 6) |
|
|
| Triglycerides: Percent change at Week 41 (n= 6) |
|
|
| Triglycerides: Percent change at Week 42 (n= 6) |
|
|
| Triglycerides: Percent change at Week 44 (n= 8) |
|
|
| Triglycerides: Percent change at Week 46 (n= 8) |
|
|
| Triglycerides: Percent change at Week 50 (n= 8) |
|
|
| Triglycerides: Percent change at Week 54 (n= 8) |
|
|
| Triglycerides: Percent change at Week 58 (n= 6) |
|
|
| Triglycerides: Percent change at Week 70 (n= 4) |
|
|
| Triglycerides: Percent change at Week 82 (n= 4) |
|
|
| Triglycerides: Percent change at Week 94 (n= 1) |
|
|
| Triglycerides: Percent change at Week 106 (n= 1) |
|
|
| Triglycerides: Percent change at ET (n= 8) |
|
|
| Triglycerides: Percent change at EOS (n= 3) |
|
|
| Apo A-1: Percent change at Week 30 (n= 7) |
|
|
| Apo A-1: Percent change at Week 34 (n= 8) |
|
|
| Apo A-1: Percent change at Week 38 (n= 8) |
|
|
| Apo A-1: Percent change at Week 42 (n= 6) |
|
|
| Apo A-1: Percent change at Week 44 (n= 8) |
|
|
| Apo A-1: Percent change at Week 50 (n= 8) |
|
|
| Apo A-1: Percent change at Week 70 (n= 4) |
|
|
| Apo A-1: Percent change at Week 82 (n= 4) |
|
|
| Apo A-1: Percent change at Week 94 (n= 1) |
|
|
| Apo A-1: Percent change at Week 106 (n= 1) |
|
|
| Apo A-1: Percent change at ET (n= 8) |
|
|
| Apo A-1: Percent change at EOS (n= 3) |
|
|
|
| HDL-C: Change at Week 29 (n= 8) |
|
|
| HDL-C: Change at Week 30 (n= 7) |
|
|
| HDL-C: Change at Week 31 (n= 8) |
|
|
| HDL-C: Change at Week 32 (n= 8) |
|
|
| HDL-C: Change at Week 34 (n= 8) |
|
|
| HDL-C: Change at Week 36 (n= 8) |
|
|
| HDL-C: Change at Week 38 (n= 8) |
|
|
| HDL-C: Change at Week 39 (n= 6) |
|
|
| HDL-C: Change at Week 40 (n= 6) |
|
|
| HDL-C: Change at Week 41 (n= 6) |
|
|
| HDL-C: Change at Week 42 (n= 6) |
|
|
| HDL-C: Change at Week 44 (n= 8) |
|
|
| HDL-C: Change at Week 46 (n= 8) |
|
|
| HDL-C: Change at Week 50 (n= 8) |
|
|
| HDL-C: Change at Week 54 (n= 8) |
|
|
| HDL-C: Change at Week 58 (n= 6) |
|
|
| HDL-C: Change at Week 70 (n= 4) |
|
|
| HDL-C: Change at Week 82 (n= 4) |
|
|
| HDL-C: Change at Week 94 (n= 1) |
|
|
| HDL-C: Change at Week 106 (n= 1) |
|
|
| HDL-C: Percent change at ET (n= 8) |
|
|
| HDL-C: Change at EOS (n= 3) |
|
|
| Triglycerides: Change at Week 27 (n= 8) |
|
|
| Triglycerides: Change at Week 28 (n= 8) |
|
|
| Triglycerides: Change at Week 29 (n= 8) |
|
|
| Triglycerides: Change at Week 30 (n= 7) |
|
|
| Triglycerides: Change at Week 31 (n= 8) |
|
|
| Triglycerides: Change at Week 32 (n= 8) |
|
|
| Triglycerides: Change at Week 34 (n= 8) |
|
|
| Triglycerides: Change at Week 36 (n= 8) |
|
|
| Triglycerides: Change at Week 38 (n= 8) |
|
|
| Triglycerides: Change at Week 39 (n= 6) |
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| Triglycerides: Change at Week 40 (n= 6) |
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| Triglycerides: Change at Week 41 (n= 6) |
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| Triglycerides: Change at Week 42 (n= 6) |
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| Triglycerides: Change at Week 44 (n= 8) |
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| Triglycerides: Change at Week 46 (n= 8) |
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| Triglycerides: Change at Week 50 (n= 8) |
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| Triglycerides: Change at Week 54 (n= 8) |
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| Triglycerides: Change at Week 58 (n= 6) |
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| Triglycerides: Change at Week 70 (n= 4) |
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| Triglycerides: Change at Week 82 (n= 4) |
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| Triglycerides: Change at Week 94 (n= 1) |
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| Triglycerides: Change at Week 106 (n= 1) |
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| Triglycerides: Change at ET (n= 8) |
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| Triglycerides: Change at EOS (n= 3) |
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|
| Apo A-1: Change at Week 30 (n= 7) |
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| Apo A-1: Change at Week 34 (n= 8) |
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| Apo A-1: Change at Week 38 (n= 8) |
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| Apo A-1: Change at Week 42 (n= 6) |
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| Apo A-1: Change at Week 44 (n= 8) |
|
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| Apo A-1: Change at Week 50 (n= 8) |
|
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| Apo A-1: Change at Week 70 (n= 4) |
|
|
| Apo A-1: Change at Week 82 (n= 4) |
|
|
| Apo A-1: Change at Week 94 (n= 1) |
|
|
| Apo A-1: Change at Week 106 (n= 1) |
|
|
| Apo A-1: Change at ET (n= 8) |
|
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| Apo A-1: Change at EOS (n= 3) |
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| Apo CIII: Change at Week 2 (n = 9) |
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| Apo CIII: Change at Week 5 (n = 8) |
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| Apo CIII: Change at Week 6 (n = 1) |
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| Apo CIII: Change at Week 12 (n = 9) |
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| Apo CIII: Change at Week 14 (n = 9) |
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| Apo CIII: Change at Week 16 (n = 9) |
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|
| Apo CIII: Percent Change at Week 2 (n = 9) |
|
|
| Apo CIII: Percent Change at Week 5 (n = 8) |
|
|
| Apo CIII: Percent Change at Week 6 (n = 1) |
|
|
| Apo CIII: Percent Change at Week 12 (n = 9) |
|
|
| Apo CIII: Percent Change at Week 14 (n = 9) |
|
|
| Apo CIII: Percent Change at Week 16 (n = 9) |
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