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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1121-4356 | Other Identifier | UTN |
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| Name | Class |
|---|---|
| Regeneron Pharmaceuticals | INDUSTRY |
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Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds proprotein convertase subtilisin/kexin type 9 (PCSK9).
Primary Objective of the study:
Secondary Objectives:
The maximum study duration was 62 weeks per participant, including a 2-week screening period, 52-week randomized treatment period, and 8-week follow-up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Q2W | Placebo Comparator | Placebo (for alirocumab) every 2 weeks (Q2W) added to stable Lipid-Modifying Therapy (LMT) for 52 weeks. |
|
| Alirocumab | Experimental | Alirocumab 75 mg Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo (for alirocumab) | Drug | Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with a disposable auto-injector (also known as pre-filled pen). |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis | Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were used in the model (ITT analysis). | From Baseline to Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis | Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection) (on-treatment analysis). | From Baseline to Week 52 |
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Inclusion criteria:
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number 840857 | Birmingham | Alabama | 35209 | United States | ||
| Investigational Site Number 840891 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25240705 | Background | Colhoun HM, Robinson JG, Farnier M, Cariou B, Blom D, Kereiakes DJ, Lorenzato C, Pordy R, Chaudhari U. Efficacy and safety of alirocumab, a fully human PCSK9 monoclonal antibody, in high cardiovascular risk patients with poorly controlled hypercholesterolemia on maximally tolerated doses of statins: rationale and design of the ODYSSEY COMBO I and II trials. BMC Cardiovasc Disord. 2014 Sep 20;14:121. doi: 10.1186/1471-2261-14-121. | |
| 26027630 |
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Randomization was stratified according to prior history of myocardial infarction (MI) or ischemic stroke, and intensity of statin treatment. Assignment to treatment arms was done centrally using an Interactive Voice/Web Response System in a 1:2 ratio (placebo: alirocumab) after confirmation of selection criteria. 316 participants were randomized.
The study was conducted at 76 centers in the United States of America. Overall, 640 participants were screened between July 2012 and February 2013, 324 of whom were screen failures. Screen failures were mainly due to exclusion criteria met.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Q2W | Placebo (for alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable Lipid-Modifying Therapy (LMT) for 52 weeks. |
| FG001 | Alirocumab 75/150 mg Q2W |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Alirocumab | Drug | Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with a disposable auto-injector (also known as pre-filled pen). |
|
|
| Lipid-Modifying Therapy (LMT) | Drug | Statin (rosuvastatin, simvastatin or atorvastatin) at stable dose with or without other LMT as clinically indicated. |
|
| Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis |
Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment. |
| From Baseline to Week 52 |
| Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis | Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection). | From Baseline to Week 52 |
| Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis | Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment. | From baseline to Week 52 |
| Percent Change From Baseline in Apo B at Week 24 - On-treatment Analysis | Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection). | From Baseline to Week 52 |
| Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis | Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment. | From Baseline to Week 52 |
| Percent Change From Baseline in Non-HDL-C at Week 24 - On-treatment Analysis | Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection). | From Baseline to Week 52 |
| Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis | Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment. | From Baseline to Week 52 |
| Percent Change From Baseline in Apo B at Week 12 - ITT Analysis | Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment. | From Baseline to Week 52 |
| Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis | Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment. | From Baseline to Week 52 |
| Percent Change From Baseline in Total-C at Week 12 - ITT Analysis | Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment. | From Baseline to Week 52 |
| Percent Change From Baseline in Calculated LDL-C at Week 52 - ITT Analysis | Adjusted LS means and standard errors at Week 52 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment. | From Baseline to Week 52 |
| Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis | Adjusted percentages at Week 24 were obtained from multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were included in the imputation model. | Up to Week 52 |
| Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-treatment Analysis | Adjusted percentages at Week 24 from multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 52 i.e. up to 21 days after last injection. | Up to Week 52 |
| Percent Change From Baseline in Lipoprotein(a) at Week 24 - ITT Analysis | Adjusted means and standard errors at Week 24 were obtained from multiple imputation approach followed by robust regression model for handling of missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were included in the imputation model. | From baseline to Week 52 |
| Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis | Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment. | From Baseline to Week 52 |
| Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis | Adjusted means and standard errors at Week 24 from multiple imputation approach followed be robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment. | From Baseline to Week 52 |
| Percent Change From Baseline in Apolipoprotein A-1 at Week 24 - ITT Analysis | Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment. | From Baseline to Week 52 |
| Percent Change From Baseline in Lipoprotein(a) at Week 12- ITT Analysis | Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment. | From Baseline to Week 52 |
| Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis | Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment. | From Baseline to Week 52 |
| Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis | Adjusted means and standard errors at Week 12 from multiple imputation approach followed by a robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment. | From Baseline to Week 52 |
| Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis | Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment. | From Baseline to Week 52 |
| Mobile |
| Alabama |
| 36693 |
| United States |
| Investigational Site Number 840876 | Montgomery | Alabama | 36109 | United States |
| Investigational Site Number 840865 | Glendale | Arizona | 85306 | United States |
| Investigational Site Number 840826 | Jonesboro | Arkansas | 72401 | United States |
| Investigational Site Number 840870 | Burbank | California | 91505 | United States |
| Investigational Site Number 840851 | Los Angeles | California | 90057 | United States |
| Investigational Site Number 840845 | Los Gatos | California | 95032 | United States |
| Investigational Site Number 840844 | Sacramento | California | 95823 | United States |
| Investigational Site Number 840801 | San Jose | California | 95116 | United States |
| Investigational Site Number 840886 | Tarzana | California | 91356 | United States |
| Investigational Site Number 840862 | Torrance | California | 90505 | United States |
| Investigational Site Number 840893 | Vista | California | 92083 | United States |
| Investigational Site Number 840867 | Boca Raton | Florida | 33432 | United States |
| Investigational Site Number 840884 | Boynton Beach | Florida | 33472 | United States |
| Investigational Site Number 840836 | Clearwater | Florida | 33761 | United States |
| Investigational Site Number 840866 | Coral Gables | Florida | 33134 | United States |
| Investigational Site Number 840895 | Fort Lauderdale | Florida | 33308-4311 | United States |
| Investigational Site Number 840820 | Hialeah | Florida | United States |
| Investigational Site Number 840805 | Miami | Florida | 33143 | United States |
| Investigational Site Number 840811 | Oviedo | Florida | 32765 | United States |
| Investigational Site Number 840881 | Port Orange | Florida | 32127 | United States |
| Investigational Site Number 840816 | West Palm Beach | Florida | United States |
| Investigational Site Number 840850 | Columbus | Georgia | 31904 | United States |
| Investigational Site Number 840840 | Eagle | Idaho | United States |
| Investigational Site Number 840842 | Chicago | Illinois | 60611 | United States |
| Investigational Site Number 840898 | Evanston | Illinois | 60201 | United States |
| Investigational Site Number 840847 | Morton | Illinois | 61550 | United States |
| Investigational Site Number 840896 | Indianapolis | Indiana | 46260 | United States |
| Investigational Site Number 840894 | Michigan City | Indiana | 46360 | United States |
| Investigational Site Number 840838 | Mishawaka | Indiana | 46545 | United States |
| Investigational Site Number 840823 | Paducah | Kentucky | 42003 | United States |
| Investigational Site Number 840858 | Eunice | Louisiana | 70535 | United States |
| Investigational Site Number 840802 | New Orleans | Louisiana | 70119 | United States |
| Investigational Site Number 840855 | Salisbury | Massachusetts | 01952 | United States |
| Investigational Site Number 840890 | Battle Creek | Michigan | 49015 | United States |
| Investigational Site Number 840832 | Southfield | Michigan | 48034 | United States |
| Investigational Site Number 840839 | Edina | Minnesota | 55435 | United States |
| Investigational Site Number 840888 | Minneapolis | Minnesota | 55455 | United States |
| Investigational Site Number 840837 | Port Gibson | Mississippi | 39150 | United States |
| Investigational Site Number 840814 | Jefferson City | Missouri | 65109 | United States |
| Investigational Site Number 840833 | Sparks | Nevada | United States |
| Investigational Site Number 840817 | Newington | New Hampshire | 3801 | United States |
| Investigational Site Number 840853 | New Windsor | New York | 12553 | United States |
| Investigational Site Number 840822 | Rochester | New York | 14609 | United States |
| Investigational Site Number 840824 | Cary | North Carolina | United States |
| Investigational Site Number 840880 | Smithfield | North Carolina | United States |
| Investigational Site Number 840502 | Winston-Salem | North Carolina | 27103 | United States |
| Investigational Site Number 840852 | Winston-Salem | North Carolina | 27103 | United States |
| Investigational Site Number 840846 | Cincinnati | Ohio | 45219 | United States |
| Investigational Site Number 840899 | Cincinnati | Ohio | 45245 | United States |
| Investigational Site Number 840831 | Columbus | Ohio | 43231 | United States |
| Investigational Site Number 840860 | Kettering | Ohio | 45429 | United States |
| Investigational Site Number 840809 | Willoughby Hills | Ohio | 44094 | United States |
| Investigational Site Number 840818 | Norman | Oklahoma | 73069 | United States |
| Investigational Site Number 840812 | Eugene | Oregon | 97404 | United States |
| Investigational Site Number 840803 | Downington | Pennsylvania | 19335 | United States |
| Investigational Site Number 840869 | Philadelphia | Pennsylvania | 19146 | United States |
| Investigational Site Number 840825 | Pittsburgh | Pennsylvania | 15206 | United States |
| Investigational Site Number 840872 | Anderson | South Carolina | 29621 | United States |
| Investigational Site Number 840885 | Charleston | South Carolina | 29407 | United States |
| Investigational Site Number 840813 | Greer | South Carolina | 29651 | United States |
| Investigational Site Number 840827 | Mt. Pleasant | South Carolina | 29464 | United States |
| Investigational Site Number 840868 | Corpus Christi | Texas | 78404 | United States |
| Investigational Site Number 840877 | Houston | Texas | 77070 | United States |
| Investigational Site Number 840841 | Houston | Texas | 77072 | United States |
| Investigational Site Number 840830 | San Antonio | Texas | 78224 | United States |
| Investigational Site Number 840854 | San Antonio | Texas | 78229 | United States |
| Investigational Site Number 840883 | San Antonio | Texas | 78258 | United States |
| Investigational Site Number 840889 | Tomball | Texas | 77375 | United States |
| Investigational Site Number 840878 | Bountiful | Utah | 84010 | United States |
| Investigational Site Number 840819 | Orem | Utah | 84058 | United States |
| Investigational Site Number 840863 | Salt Lake City | Utah | 84102 | United States |
| Investigational Site Number 840804 | Manassas | Virginia | 20110 | United States |
| Investigational Site Number 840882 | Norfolk | Virginia | 23507 | United States |
| Investigational Site Number 840810 | Weber City | Virginia | 24290 | United States |
| Result |
| Kereiakes DJ, Robinson JG, Cannon CP, Lorenzato C, Pordy R, Chaudhari U, Colhoun HM. Efficacy and safety of the proprotein convertase subtilisin/kexin type 9 inhibitor alirocumab among high cardiovascular risk patients on maximally tolerated statin therapy: The ODYSSEY COMBO I study. Am Heart J. 2015 Jun;169(6):906-915.e13. doi: 10.1016/j.ahj.2015.03.004. Epub 2015 Mar 13. |
| 34298554 | Derived | Mahmood T, Minnier J, Ito MK, Li QH, Koren A, Kam IW, Fazio S, Shapiro MD. Discordant responses of plasma low-density lipoprotein cholesterol and lipoprotein(a) to alirocumab: A pooled analysis from 10 ODYSSEY Phase 3 studies. Eur J Prev Cardiol. 2021 Jul 23;28(8):816-822. doi: 10.1177/2047487320915803. Epub 2020 Apr 10. |
| 30183102 | Derived | Leiter LA, Tinahones FJ, Karalis DG, Bujas-Bobanovic M, Letierce A, Mandel J, Samuel R, Jones PH. Alirocumab safety in people with and without diabetes mellitus: pooled data from 14 ODYSSEY trials. Diabet Med. 2018 Dec;35(12):1742-1751. doi: 10.1111/dme.13817. Epub 2018 Oct 9. |
| 27777279 | Derived | Ray KK, Ginsberg HN, Davidson MH, Pordy R, Bessac L, Minini P, Eckel RH, Cannon CP. Reductions in Atherogenic Lipids and Major Cardiovascular Events: A Pooled Analysis of 10 ODYSSEY Trials Comparing Alirocumab With Control. Circulation. 2016 Dec 13;134(24):1931-1943. doi: 10.1161/CIRCULATIONAHA.116.024604. Epub 2016 Oct 24. |
Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Q2W | Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks. |
| BG001 | Alirocumab 75/150 mg Q2W | Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| 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 | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Calculated LDL-C in mmol/L | Calculated LDL-C in mmol/L from Friedewald formula (LDL cholesterol = Total cholesterol - HDL cholesterol - [Triglyceride/2.2]). | Mean | Standard Deviation | mmol/L |
| ||||||||||||||
| Calculated LDL-C in mg/dL | Calculated LDL-C in mg/dL from Friedewald formula (LDL cholesterol = Total cholesterol - HDL cholesterol - [Triglyceride/5]). | Mean | Standard Deviation | mg/dL |
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| 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 | Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis | Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were used in the model (ITT analysis). | ITT population: all randomized participants with one baseline and at least one post-baseline calculated LDL-C value on- or off-treatment. | Posted | Least Squares Mean | Standard Error | percent change | From Baseline to Week 52 |
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| Secondary | Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis | Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection) (on-treatment analysis). | Modified ITT (mITT) population: all randomized and treated participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment. | Posted | Least Squares Mean | Standard Error | percent change | From Baseline to Week 52 |
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| Secondary | Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis | Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment. | ITT population. | Posted | Least Squares Mean | Standard Error | percent change | From Baseline to Week 52 |
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| Secondary | Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis | Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection). | mITT population. | Posted | Least Squares Mean | Standard Error | percent change | From Baseline to Week 52 |
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| Secondary | Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis | Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment. | Participants of the ITT population with one baseline and at least one post-baseline Apo B value on- or off-treatment (Apo B ITT population). | Posted | Least Squares Mean | Standard Error | percent change | From baseline to Week 52 |
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| Secondary | Percent Change From Baseline in Apo B at Week 24 - On-treatment Analysis | Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection). | Participants of the mITT population with one baseline and at least one post-baseline Apo B value on-treatment (Apo B mITT population). | Posted | Least Squares Mean | Standard Error | percent change | From Baseline to Week 52 |
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| Secondary | Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis | Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment. | Participants of the ITT population with one baseline and at least one post-baseline non-HDL-C value on- or off-treatment (non-HDL-C ITT population). | Posted | Least Squares Mean | Standard Error | percent change | From Baseline to Week 52 |
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| Secondary | Percent Change From Baseline in Non-HDL-C at Week 24 - On-treatment Analysis | Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection). | Participants of the mITT population with one baseline and at least one post-baseline non-HDL-C value on-treatment (non-HDL-C mITT population). | Posted | Least Squares Mean | Standard Error | percent change | From Baseline to Week 52 |
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| Secondary | Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis | Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment. | Participants of the ITT population with one baseline and at least one post-baseline Total-C value on- or off-treatment (Total-C ITT population). | Posted | Least Squares Mean | Standard Error | percent change | From Baseline to Week 52 |
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| Secondary | Percent Change From Baseline in Apo B at Week 12 - ITT Analysis | Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment. | Apo B ITT population. | Posted | Least Squares Mean | Standard Error | percent change | From Baseline to Week 52 |
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| Secondary | Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis | Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment. | Non-HDL-C ITT population. | Posted | Least Squares Mean | Standard Error | percent change | From Baseline to Week 52 |
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| Secondary | Percent Change From Baseline in Total-C at Week 12 - ITT Analysis | Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment. | Total-C ITT population. | Posted | Least Squares Mean | Standard Error | percent change | From Baseline to Week 52 |
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| Secondary | Percent Change From Baseline in Calculated LDL-C at Week 52 - ITT Analysis | Adjusted LS means and standard errors at Week 52 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment. | ITT population. | Posted | Least Squares Mean | Standard Error | percent change | From Baseline to Week 52 |
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| Secondary | Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis | Adjusted percentages at Week 24 were obtained from multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were included in the imputation model. | ITT population. | Posted | Number | percentage of participants | Up to Week 52 |
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| Secondary | Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-treatment Analysis | Adjusted percentages at Week 24 from multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 52 i.e. up to 21 days after last injection. | mITT population. | Posted | Number | percentage of participants | Up to Week 52 |
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| Secondary | Percent Change From Baseline in Lipoprotein(a) at Week 24 - ITT Analysis | Adjusted means and standard errors at Week 24 were obtained from multiple imputation approach followed by robust regression model for handling of missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were included in the imputation model. | ITT population. | Posted | Mean | Standard Error | percent change | From baseline to Week 52 |
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| Secondary | Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis | Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment. | Participants of the ITT population with one baseline and at least one post-baseline HDL-C value on- or off-treatment (HDL-C ITT population). | Posted | Least Squares Mean | Standard Error | percent change | From Baseline to Week 52 |
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| Secondary | Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis | Adjusted means and standard errors at Week 24 from multiple imputation approach followed be robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment. | ITT population. | Posted | Mean | Standard Error | percent change | From Baseline to Week 52 |
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| Secondary | Percent Change From Baseline in Apolipoprotein A-1 at Week 24 - ITT Analysis | Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment. | Participants of the ITT population with one baseline and at least one post-baseline Apo A-1 value on- or off-treatment (Apo A-1 ITT population). | Posted | Least Squares Mean | Standard Error | percent change | From Baseline to Week 52 |
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| Secondary | Percent Change From Baseline in Lipoprotein(a) at Week 12- ITT Analysis | Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment. | ITT population. | Posted | Mean | Standard Error | percent change | From Baseline to Week 52 |
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| Secondary | Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis | Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment. | HDL-C ITT population. | Posted | Least Squares Mean | Standard Error | percent change | From Baseline to Week 52 |
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| Secondary | Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis | Adjusted means and standard errors at Week 12 from multiple imputation approach followed by a robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment. | ITT population. | Posted | Mean | Standard Error | percent change | From Baseline to Week 52 |
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| Secondary | Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis | Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment. | Apo A-1 ITT population. | Posted | Least Squares Mean | Standard Error | percent change | From Baseline to Week 52 |
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All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 60 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product.
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo Q2W | Participants exposed to placebo (for alirocumab) SC injection Q2W added to stable LMT (mean exposition of 45 weeks). | 14 | 107 | 31 | 107 | ||
| EG001 | Alirocumab 75 /up to 150 mg Q2W | Participants exposed to alirocumab 75 mg /up to 150 mg SC injection Q2W added to stable LMT (mean exposition of 46 weeks). | 26 | 207 | 72 | 207 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Colon adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
| |
| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
| |
| Chronic myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
| |
| Oesophageal adenocarcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dementia | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hypoglycaemic coma | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Intracardiac thrombus | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Ischaemic cardiomyopathy | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Extremity necrosis | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Intussusception | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Mesenteric vein thrombosis | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
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| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
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| Renal failure | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
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| Chest pain | General disorders | MedDRA 17.0 | Systematic Assessment |
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| Non-cardiac chest pain | General disorders | MedDRA 17.0 | Systematic Assessment |
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| Sudden cardiac death | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Traumatic haematoma | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Intentional overdose | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Jaw fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Muscle rupture | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Postoperative ileus | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Tooth injury | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA 17.0 | Systematic Assessment |
|
If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | Sanofi | Contact -US@sanofi.com |
| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C571059 | alirocumab |
Not provided
Not provided
Not provided
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