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CompletedNCT01644188Updated Aug 4, 2016Results posted

Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe on Top of Statin in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY COMBO II)

A Phase 3 interventional study of Alirocumab and Placebo (for alirocumab) in Hypercholesterolemia, sponsored by Sanofi. Completed at 126 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-08-04.

Sponsored by Sanofi · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
720
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9).

Primary Objective of the study:

To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as add-on therapy to stable maximally tolerated daily statin therapy in comparison with ezetimibe after 24 weeks of treatment in participants with hypercholesterolemia at high cardiovascular (CV) risk.

Secondary Objectives:

  • To evaluate the effect of alirocumab in comparison with ezetimibe on LDL-C at other time points
  • To evaluate the effect of alirocumab on other lipid parameters
  • To evaluate the safety and tolerability of alirocumab
Read the detailed description

The maximum study duration was 115 weeks per participant, including a 3-week screening period, 104-week randomized treatment period and 8-week follow-up period.

02

Conditions studied

  • Hypercholesterolemia
03

In context

Hypercholesterolemia

1,267 studies on the registry are indexed under Hypercholesterolemia; 105 are open to participants now.

This study's enrollment of 720 is above the median of 100 across 1,015 interventional studies indexed under Hypercholesterolemia.

Browse Hypercholesterolemia studies →

Lead sponsor

Sanofi is the lead sponsor of 1,547 studies on the registry; 88 are open to participants now.

Of its 204 completed or terminated interventional studies of FDA-regulated products, 122 (60%) have results posted.

Browse Sanofi studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Participants with hypercholesterolemia and established coronary heart disease (CHD) or CHD risk equivalents who were not adequately controlled with a maximally tolerated daily dose of statin at stable dose for at least 4 weeks prior to the screening visit (Week -2).

Exclusion criteria

Exclusion criteria:

  • Age \< 18 or legal age of adulthood, whichever was greater
  • Participants without established CHD or CHD risk equivalents
  • LDL-C \<70 mg/dL (\<1.81 mmol/L) and participants with a history of documented cardiovascular disease
  • LDL-C \<100 mg/dL (\<2.59 mmol/L) and participants without a history of documented CV disease
  • Fasting serum triglycerides >400 mg/dL (>4.52 mmol/L)

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
720 participants (actual)

Study arms

  • Experimental
    Alirocumab 75 /up to 150 mg Q2W

    Alirocumab 75 mg every 2 weeks (Q2W) and oral placebo capsule for ezetimibe daily added to stable Lipid Modifying Therapy (LMT) for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.

    Drug: Alirocumab · Drug: Placebo (for ezetimibe) · Drug: Lipid Modifying Therapy (LMT)

  • Active comparator
    Ezetimibe 10 mg

    Ezetimibe 10 mg capsule daily and subcutaneous placebo for alirocumab Q2W added to stable LMT for 104 weeks.

    Drug: Placebo (for alirocumab) · Drug: Ezetimibe · Drug: Lipid Modifying Therapy (LMT)

Interventions

  • DrugAlirocumab

    1 mL subcutaneous injection in the abdomen, thigh, or outer area of the upper arm by self-injection or by another designated person using the autoinjector.

    Also known as: REGN727/SAR236553, Praluent

  • DrugPlacebo (for alirocumab)

    1 mL subcutaneous injection in the abdomen, thigh, or outer area of the upper arm by self-injection or by another designated person using the autoinjector.

  • DrugEzetimibe

    One over-encapsulated tablet orally once daily at approximately the same time of the day with or without food.

  • DrugPlacebo (for ezetimibe)

    One capsule once daily orally at approximately the same time of the day with or without food.

  • DrugLipid Modifying Therapy (LMT)

    Statin (rosuvastatin, simvastatin or atorvastatin) at stable dose.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: From Baseline to Week 52

Secondary outcomes

  1. 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 or 3 days after the last capsule, whichever came first).

    Time frame: From Baseline to Week 52

  2. Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis

    Adjusted LS means and standard errors at Week 12 from a MMRM including all available post-baseline data from week 4 to week 52 regardless of status on- or off-treatment.

    Time frame: From Baseline to Week 52

  3. 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 or 3 days after the last capsule, whichever came first).

    Time frame: From Baseline to Week 52

  4. Percent Change From Baseline in Apolipoprotein B (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.

    Time frame: From Baseline to Week 52

  5. 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 or 3 days after the last capsule, whichever came first).

    Time frame: From Baseline to Week 52

  6. 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.

    Time frame: From Baseline to Week 52

  7. 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 or 3 days after the last capsule, whichever came first).

    Time frame: From Baseline up to Week 52

  8. 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.

    Time frame: From Baseline to Week 52

  9. 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.

    Time frame: From Baseline to Week 52

  10. 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.

    Time frame: From Baseline to Week 52

  11. 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.

    Time frame: From Baseline to Week 52

  12. Percent Change From Baseline in Calculated LDL-C at Week 52 - ITT Analysis

    Adjusted LS means and standard errors at Week 52 from a MMRM model including all available post-baseline data from week 4 to week 52 regardless of status on- or off-treatment.

    Time frame: From Baseline to Week 52

  13. Percentage of Participants Achieving 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 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.

    Time frame: Up to Week 52

  14. Percentage of Participants Achieving 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 including available post-baseline on-treatment data from week 4 to week 52 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first).

    Time frame: Up to Week 52

  15. 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.

    Time frame: From baseline to Week 52

  16. 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.

    Time frame: From Baseline to Week 52

  17. 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 by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.

    Time frame: From Baseline to Week 52

  18. Percent Change From Baseline in Apolipoprotein A-1 (Apo 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.

    Time frame: From Baseline to Week 52

  19. 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.

    Time frame: From Baseline to Week 52

  20. 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.

    Time frame: From Baseline to Week 52

  21. 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 robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.

    Time frame: From Baseline to Week 52

  22. 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.

    Time frame: From Baseline to Week 52

Other outcomes

  1. Percent Change From Baseline in Calculated LDL-C at Week 52 - On-Treatment Analysis

    Adjusted LS means and standard errors at Week 52 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 or 3 days after the last capsule, whichever came first).

    Time frame: From Baseline to Week 52

  2. Percent Change From Baseline in Calculated LDL-C at Week 104 - ITT Analysis

    Adjusted LS means and standard errors at Week 104 from MMRM including all available post-baseline data from Week 4 to Week 104 regardless of status on-or off-treatment.

    Time frame: From Baseline to Week 104

  3. Percent Change From Baseline in Calculated LDL-C at Week 104 - On-Treatment Analysis

    Adjusted LS means and standard errors at Week 104 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 104 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first).

    Time frame: From Baseline to Week 104

07

Results

Posted Nov 6, 2015
Limitations and caveats
Manual reclassification was done by the Sponsor for the "other reasons" of non-completion of study as specified in the electronic case report form (eCRF).

Participant flow

The study was conducted at 126 centers in 10 countries. Overall, 1112 participants were screened between August 2012 and May 2013, 392 of whom were screen failures. Screen failures were mainly due to exclusion criteria met.

Participant flow — Overall Study
MilestoneAlirocumab 75 /up to 150 mg Q2WEzetimibe 10 mg
Started479241
Treated479241
Completed357166
Not completed12275
Withdrew: Adverse event4420
Withdrew: Poor compliance to protocol2614
Withdrew: Physician decision13
Withdrew: Participant moved72
Withdrew: Related to auto-injector administration22
Withdrew: Consent withdrawn by participant147
Withdrew: Selection criteria finally not met20
Withdrew: Lost to follow-up10
Withdrew: Death43
Withdrew: Last visit outside protocol visit window1416
Withdrew: Site closure11
Withdrew: Other than specified above67

Outcome measures

PrimaryPercent 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).

Time frame:
From Baseline to Week 52
Reported as:
Least squares mean · percent change
Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-treat (ITT) Analysis
percent changeAlirocumab 75 /up to 150 mg Q2WEzetimibe 10 mg
Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-treat (ITT) Analysis-50.6 ± 1.4-20.7 ± 1.9
Statistical analysis
  • Alirocumab 75 /up to 150 mg Q2W vs Ezetimibe 10 mg · Mixed Models Analysis · p = <0.0001 (Threshold for significance ≤0.05.) · Ls mean difference: -29.8 · 95% CI -34.4 to -25.3Alirocumab vs. ezetimibe
SecondaryPercent 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 or 3 days after the last capsule, whichever came first).

Time frame:
From Baseline to Week 52
Reported as:
Least squares mean · percent change
Percent Change From Baseline in Calculated LDL--C at Week 24 - On--Treatment Analysis
percent changeAlirocumab 75 /up to 150 mg Q2WEzetimibe 10 mg
Percent Change From Baseline in Calculated LDL--C at Week 24 - On--Treatment Analysis-52.4 ± 1.3-21.8 ± 1.8
Statistical analysis
  • Alirocumab 75 /up to 150 mg Q2W vs Ezetimibe 10 mg · Mixed Models Analysis · p = <0.0001 (Threshold for significance ≤0.05) · Ls mean difference: -30.6 · 95% CI -34.9 to -26.2Alirocumab vs. ezetimibe
SecondaryPercent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis

Adjusted LS means and standard errors at Week 12 from a MMRM including all available post-baseline data from week 4 to week 52 regardless of status on- or off-treatment.

Time frame:
From Baseline to Week 52
Reported as:
Least squares mean · percent change
Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis
percent changeAlirocumab 75 /up to 150 mg Q2WEzetimibe 10 mg
Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis-51.2 ± 1.3-21.8 ± 1.8
Statistical analysis
  • Alirocumab 75 /up to 150 mg Q2W vs Ezetimibe 10 mg · Mixed Models Analysis · p = <0.0001 (Threshold for significance ≤0.05.) · Ls mean difference: -29.4 · 95% CI -33.7 to -25.1Alirocumab vs. ezetimibe
SecondaryPercent 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 or 3 days after the last capsule, whichever came first).

Time frame:
From Baseline to Week 52
Reported as:
Least squares mean · percent change
Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis
percent changeAlirocumab 75 /up to 150 mg Q2WEzetimibe 10 mg
Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis-52.4 ± 1.2-22.7 ± 1.7
Statistical analysis
  • Alirocumab 75 /up to 150 mg Q2W vs Ezetimibe 10 mg · Mixed Models Analysis · p = <0.0001 (Threshold for significance ≤ 0.05.) · Ls mean difference: -29.7 · 95% CI -33.8 to -25.6Alirocumab vs. ezetimibe
SecondaryPercent Change From Baseline in Apolipoprotein B (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.

Time frame:
From Baseline to Week 52
Reported as:
Least squares mean · percent change
Percent Change From Baseline in Apolipoprotein B (Apo-B) at Week 24 - ITT Analysis
percent changeAlirocumab 75 /up to 150 mg Q2WEzetimibe 10 mg
Percent Change From Baseline in Apolipoprotein B (Apo-B) at Week 24 - ITT Analysis-40.7 ± 1.1-18.3 ± 1.5
Statistical analysis
  • Alirocumab 75 /up to 150 mg Q2W vs Ezetimibe 10 mg · Mixed Models Analysis · p = <0.0001 (Threshold for significance ≤ 0.05.) · Ls mean difference: -22.4 · 95% CI -26 to -18.8Alirocumab vs. ezetimibe
SecondaryPercent 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 or 3 days after the last capsule, whichever came first).

Time frame:
From Baseline to Week 52
Reported as:
Least squares mean · percent change
Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis
percent changeAlirocumab 75 /up to 150 mg Q2WEzetimibe 10 mg
Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis-42.1 ± 1-19.1 ± 1.4
Statistical analysis
  • Alirocumab 75 /up to 150 mg Q2W vs Ezetimibe 10 mg · Mixed Models Analysis · p = <0.0001 (Threshold for significance ≤ 0.05.) · Ls mean difference: -23 · 95% CI -26.5 to -19.6Alirocumab vs. ezetimibe
SecondaryPercent 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.

Time frame:
From Baseline to Week 52
Reported as:
Least squares mean · percent change
Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis
percent changeAlirocumab 75 /up to 150 mg Q2WEzetimibe 10 mg
Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis-42.1 ± 1.2-19.2 ± 1.7
Statistical analysis
  • Alirocumab 75 /up to 150 mg Q2W vs Ezetimibe 10 mg · Mixed Models Analysis · p = <0.0001 (Threshold for significance ≤ 0.05.) · Ls mean difference: -22.9 · 95% CI -26.9 to -18.9Alirocumab vs. ezetimibe
SecondaryPercent 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 or 3 days after the last capsule, whichever came first).

Time frame:
From Baseline up to Week 52
Reported as:
Least squares mean · percent change
Percent Change From Baseline in Non-HDL-C at Week 24 - On-Treatment Analysis
percent changeAlirocumab 75 /up to 150 mg Q2WEzetimibe 10 mg
Percent Change From Baseline in Non-HDL-C at Week 24 - On-Treatment Analysis-43.7 ± 1.1-20.2 ± 1.6
Statistical analysis
  • Alirocumab 75 /up to 150 mg Q2W vs Ezetimibe 10 mg · Mixed Models Analysis · p = <0.0001 (Threshold for significance ≤ 0.05.) · Ls mean difference: -23.5 · 95% CI -27.2 to -19.7Alirocumab vs. ezetimibe
SecondaryPercent 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.

Time frame:
From Baseline to Week 52
Reported as:
Least squares mean · percent change
Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis
percent changeAlirocumab 75 /up to 150 mg Q2WEzetimibe 10 mg
Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis-29.3 ± 0.9-14.6 ± 1.2
Statistical analysis
  • Alirocumab 75 /up to 150 mg Q2W vs Ezetimibe 10 mg · Mixed Models Analysis · p = <0.0001 (Threshold for significance ≤ 0.05.) · Ls mean difference: -14.7 · 95% CI -17.7 to -11.7Alirocumab vs. ezetimibe
SecondaryPercent 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.

Time frame:
From Baseline to Week 52
Reported as:
Least squares mean · percent change
Percent Change From Baseline in Apo-B at Week 12 - ITT Analysis
percent changeAlirocumab 75 /up to 150 mg Q2WEzetimibe 10 mg
Percent Change From Baseline in Apo-B at Week 12 - ITT Analysis-39.7 ± 1-17.2 ± 1.3
Statistical analysis
  • Alirocumab 75 /up to 150 mg Q2W vs Ezetimibe 10 mg · Mixed Models Analysis · p = <0.0001 (Threshold for significance ≤ 0.05.) · Ls mean difference: -22.5 · 95% CI -25.7 to -19.2Alirocumab vs. ezetimibe
SecondaryPercent 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.

Time frame:
From Baseline to Week 52
Reported as:
Least squares mean · percent change
Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis
percent changeAlirocumab 75 /up to 150 mg Q2WEzetimibe 10 mg
Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis-42.6 ± 1.1-20.6 ± 1.5
Statistical analysis
  • Alirocumab 75 /up to 150 mg Q2W vs Ezetimibe 10 mg · Mixed Models Analysis · p = <0.0001 (Threshold for significance ≤ 0.05.) · Ls mean difference: -22 · 95% CI -25.6 to -18.3Alirocumab vs. ezetimibe
SecondaryPercent 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.

Time frame:
From Baseline to Week 52
Reported as:
Least squares mean · percent change
Percent Change From Baseline in Total-C at Week 12 - ITT Analysis
percent changeAlirocumab 75 /up to 150 mg Q2WEzetimibe 10 mg
Percent Change From Baseline in Total-C at Week 12 - ITT Analysis-29.4 ± 0.8-15.1 ± 1.1
Statistical analysis
  • Alirocumab 75 /up to 150 mg Q2W vs Ezetimibe 10 mg · Mixed Models Analysis · p = <0.0001 (Threshold for significance ≤ 0.05.) · Ls mean difference: -14.3 · 95% CI -17.1 to -11.6Alirocumab vs. ezetimibe
SecondaryPercent Change From Baseline in Calculated LDL-C at Week 52 - ITT Analysis

Adjusted LS means and standard errors at Week 52 from a MMRM model including all available post-baseline data from week 4 to week 52 regardless of status on- or off-treatment.

Time frame:
From Baseline to Week 52
Reported as:
Least squares mean · percent change
Percent Change From Baseline in Calculated LDL-C at Week 52 - ITT Analysis
percent changeAlirocumab 75 /up to 150 mg Q2WEzetimibe 10 mg
Percent Change From Baseline in Calculated LDL-C at Week 52 - ITT Analysis-49.5 ± 1.5-18.3 ± 2.1
Statistical analysis
  • Alirocumab 75 /up to 150 mg Q2W vs Ezetimibe 10 mg · Mixed Models Analysis · p = <0.0001 (Threshold for significance ≤ 0.05.) · Ls mean difference: -31.2 · 95% CI -36.3 to -26.1Alirocumab vs. ezetimibe
SecondaryPercentage of Participants Achieving 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 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.

Time frame:
Up to Week 52
Reported as:
Number · percentage of participants
Percentage of Participants Achieving Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis
percentage of participantsAlirocumab 75 /up to 150 mg Q2WEzetimibe 10 mg
Percentage of Participants Achieving Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis7745.6
Statistical analysis
  • Alirocumab 75 /up to 150 mg Q2W vs Ezetimibe 10 mg · Regression, Logistic · p = <0.0001 (Threshold for significance ≤ 0.05.) · Odds ratio (or): 5.4 · 95% CI 3.7 to 7.9Alirocumab vs. ezetimibe
SecondaryPercentage of Participants Achieving 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 including available post-baseline on-treatment data from week 4 to week 52 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first).

Time frame:
Up to Week 52
Reported as:
Number · percentage of participants
Percentage of Participants Achieving Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis
percentage of participantsAlirocumab 75 /up to 150 mg Q2WEzetimibe 10 mg
Percentage of Participants Achieving Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis78.947.4
Statistical analysis
  • Alirocumab 75 /up to 150 mg Q2W vs Ezetimibe 10 mg · Regression, Logistic · p = <0.0001 (Threshold for significance ≤ 0.05.) · Odds ratio (or): 5.9 · 95% CI 3.9 to 8.8Alirocumab vs. ezetimibe
SecondaryPercent 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.

Time frame:
From baseline to Week 52
Reported as:
Mean · percent change
Percent Change From Baseline in Lipoprotein(a) at Week 24 - ITT Analysis
percent changeAlirocumab 75 /up to 150 mg Q2WEzetimibe 10 mg
Percent Change From Baseline in Lipoprotein(a) at Week 24 - ITT Analysis-27.8 ± 1.4-6.1 ± 2
Statistical analysis
  • Alirocumab 75 /up to 150 mg Q2W vs Ezetimibe 10 mg · Regression, Robust · p = <0.0001 (Threshold for significance ≤ 0.05.) · Adjusted mean difference: -21.7 · 95% CI -26.4 to -17Alirocumab vs. ezetimibe
SecondaryPercent 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.

Time frame:
From Baseline to Week 52
Reported as:
Least squares mean · percent change
Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis
percent changeAlirocumab 75 /up to 150 mg Q2WEzetimibe 10 mg
Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis8.6 ± 0.80.5 ± 1.1
Statistical analysis
  • Alirocumab 75 /up to 150 mg Q2W vs Ezetimibe 10 mg · Mixed Models Analysis · p = <0.0001 (Threshold for significance ≤ 0.05.) · Ls mean difference: 8.1 · 95% CI 5.4 to 10.7Alirocumab vs. ezetimibe
SecondaryPercent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis

Adjusted means and standard errors at Week 24 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.

Time frame:
From Baseline to Week 52
Reported as:
Mean · percent change
Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis
percent changeAlirocumab 75 /up to 150 mg Q2WEzetimibe 10 mg
Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis-13 ± 1.5-12.8 ± 2
Statistical analysis
  • Alirocumab 75 /up to 150 mg Q2W vs Ezetimibe 10 mg · Regression, Robust · p = 0.9117 (Threshold for significance ≤ 0.05.) · Adjusted mean difference: -0.3 · 95% CI -5.1 to 4.6Alirocumab vs. ezetimibe
SecondaryPercent Change From Baseline in Apolipoprotein A-1 (Apo 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.

Time frame:
From Baseline to Week 52
Reported as:
Least squares mean · percent change
Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Week 24 - ITT Analysis
percent changeAlirocumab 75 /up to 150 mg Q2WEzetimibe 10 mg
Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Week 24 - ITT Analysis5 ± 0.6-1.3 ± 0.8
SecondaryPercent 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.

Time frame:
From Baseline to Week 52
Reported as:
Mean · percent change
Percent Change From Baseline in Lipoprotein(a) at Week 12 - ITT Analysis
percent changeAlirocumab 75 /up to 150 mg Q2WEzetimibe 10 mg
Percent Change From Baseline in Lipoprotein(a) at Week 12 - ITT Analysis-22.1 ± 1.21.1 ± 1.7
SecondaryPercent 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.

Time frame:
From Baseline to Week 52
Reported as:
Least squares mean · percent change
Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis
percent changeAlirocumab 75 /up to 150 mg Q2WEzetimibe 10 mg
Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis8.7 ± 0.72.8 ± 1
SecondaryPercent 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 robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.

Time frame:
From Baseline to Week 52
Reported as:
Mean · percent change
Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis
percent changeAlirocumab 75 /up to 150 mg Q2WEzetimibe 10 mg
Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis-13 ± 1.5-12.8 ± 2.0
SecondaryPercent 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.

Time frame:
From Baseline to Week 52
Reported as:
Least squares mean · percent change
Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis
percent changeAlirocumab 75 /up to 150 mg Q2WEzetimibe 10 mg
Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis1.5 ± 0.5-2.9 ± 0.7
Other pre-specifiedPercent Change From Baseline in Calculated LDL-C at Week 52 - On-Treatment Analysis

Adjusted LS means and standard errors at Week 52 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 or 3 days after the last capsule, whichever came first).

Time frame:
From Baseline to Week 52
Reported as:
Least squares mean · Percent change
Percent Change From Baseline in Calculated LDL-C at Week 52 - On-Treatment Analysis
Percent changeAlirocumab 75 /up to 150 mg Q2WEzetimibe 10 mg
Percent Change From Baseline in Calculated LDL-C at Week 52 - On-Treatment Analysis-51.8 ± 1.5-19.7 ± 2.1
Other pre-specifiedPercent Change From Baseline in Calculated LDL-C at Week 104 - ITT Analysis

Adjusted LS means and standard errors at Week 104 from MMRM including all available post-baseline data from Week 4 to Week 104 regardless of status on-or off-treatment.

Time frame:
From Baseline to Week 104
Reported as:
Least squares mean · Percent change
Percent Change From Baseline in Calculated LDL-C at Week 104 - ITT Analysis
Percent changeAlirocumab 75 /up to 150 mg Q2WEzetimibe 10 mg
Percent Change From Baseline in Calculated LDL-C at Week 104 - ITT Analysis-44.2 ± 1.7-15.2 ± 2.4
Other pre-specifiedPercent Change From Baseline in Calculated LDL-C at Week 104 - On-Treatment Analysis

Adjusted LS means and standard errors at Week 104 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 104 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first).

Time frame:
From Baseline to Week 104
Reported as:
Least squares mean · Percent change
Percent Change From Baseline in Calculated LDL-C at Week 104 - On-Treatment Analysis
Percent changeAlirocumab 75 /up to 150 mg Q2WEzetimibe 10 mg
Percent Change From Baseline in Calculated LDL-C at Week 104 - On-Treatment Analysis-48.9 ± 1.7-17.0 ± 2.4

Adverse events

Collected over All Adverse Events (AE) were collected from signature of the informed consent form up to final visit (Week 112) in the study regardless of seriousness or relationship to study drugs.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Alirocumab 75/Up to 150 mg Q2W—124/479 (25.9%)185/479 (38.6%)
Ezetimibe 10 mg—60/241 (24.9%)90/241 (37.3%)
Most frequent serious events
Showing 10 of 174
Most frequent serious events
EventAlirocumab 75/Up to 150 mg Q2WEzetimibe 10 mg
Acute myocardial infarctionCardiac disorders12/4793/241
Angina pectorisCardiac disorders10/4796/241
Angina unstableCardiac disorders9/4796/241
PneumoniaInfections and infestations9/4791/241
SyncopeNervous system disorders2/4794/241
Non-cardiac chest painGeneral disorders6/4792/241
Atrial fibrillationCardiac disorders4/4792/241
Cardiac failure congestiveCardiac disorders4/4790/241
Cardiac arrestCardiac disorders4/4790/241
Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders4/4790/241
Most frequent other events
Most frequent other events
EventAlirocumab 75/Up to 150 mg Q2WEzetimibe 10 mg
Accidental overdoseInjury, poisoning and procedural complications47/47919/241
Upper respiratory tract infectionInfections and infestations42/47917/241
DizzinessNervous system disorders28/47918/241
InfluenzaInfections and infestations22/47916/241
HypertensionVascular disorders31/47914/241
NasopharyngitisInfections and infestations23/47915/241
HeadacheNervous system disorders29/47913/241
MyalgiaMusculoskeletal and connective tissue disorders25/47913/241

Baseline characteristics

Age, Continuous
Age, Continuous(years)Alirocumab 75 /up to 150 mg Q2WEzetimibe 10 mgTotal
Mean61.7 ± 9.461.3 ± 9.261.6 ± 9.3
Sex: Female, Male
Sex: Female, Male(Participants)Alirocumab 75 /up to 150 mg Q2WEzetimibe 10 mgTotal
Female11971190
Male360170530
Calculated LDL-C in mg/dL
Calculated LDL-C in mg/dL(mg/dL)Alirocumab 75 /up to 150 mg Q2WEzetimibe 10 mgTotal
Mean108.6 ± 36.5104.6 ± 34.1107.3 ± 35.7
Calculated LDL-C in mmol/L
Calculated LDL-C in mmol/L(mmol/L)Alirocumab 75 /up to 150 mg Q2WEzetimibe 10 mgTotal
Mean2.812 ± 0.9452.710 ± 0.8842.778 ± 0.926
08

Study locations

126 sites
  • Investigational Site Number 840980
    Birmingham, Alabama 35209, United States
  • Investigational Site Number 840918
    Phoenix, Arizona 85032, United States
  • Investigational Site Number 840925
    Tucson, Arizona, United States
  • Investigational Site Number 840959
    Anaheim, California 92801, United States
  • Investigational Site Number 840301
    Beverly Hills, California 90211, United States
  • Investigational Site Number 840933
    Chino, California 91710, United States
  • Investigational Site Number 840991
    Lincoln, California 95648, United States
  • Investigational Site Number 840979
    Los Angeles, California 90057, United States
  • Investigational Site Number 840952
    Palm Springs, California 92262, United States
  • Investigational Site Number 840930
    Thousand Oaks, California 91360, United States
  • Investigational Site Number 840921
    Vista, California 92083, United States
  • Investigational Site Number 840962
    Boynton Beach, Florida 33472, United States
  • Investigational Site Number 840987
    Bradenton, Florida 34203, United States
  • Investigational Site Number 840302
    Clearwater, Florida 33756, United States
  • Investigational Site Number 840935
    Jacksonville, Florida 32223, United States
  • Investigational Site Number 840903
    Miami, Florida 33126, United States
  • Investigational Site Number 840920
    Miami, Florida, United States
  • Investigational Site Number 840943
    Ocala, Florida 34471, United States
  • Investigational Site Number 840981
    Oveido, Florida 32765, United States
  • Investigational Site Number 840961
    Port Orange, Florida 32127, United States
  • Investigational Site Number 840303
    Sarasota, Florida 34239, United States
  • Investigational Site Number 840986
    St. Petersburg, Florida, United States
  • Investigational Site Number 840988
    St. Petersburg, Florida, United States
  • Investigational Site Number 840995
    Meridian, Idaho 83646, United States
  • Investigational Site Number 840902
    Evansville, Indiana 47714, United States
  • Investigational Site Number 840960
    Topeka, Kansas 66606, United States
  • Investigational Site Number 840940
    Oxon Hill, Maryland 20745, United States
  • Investigational Site Number 840966
    Fall River, Massachusetts 02720, United States
  • Investigational Site Number 840917
    Kansas City, Missouri 64114, United States
  • Investigational Site Number 840998
    St Louis, Missouri 63131, United States
  • Investigational Site Number 840946
    Butte, Montana 59701, United States
  • Investigational Site Number 840914
    Lincoln, Nebraska 68510, United States
  • Investigational Site Number 840949
    Albuquerque, New Mexico 87106, United States
  • Investigational Site Number 840974
    New Windsor, New York 12553, United States
  • Investigational Site Number 840955
    Greenville, North Carolina 27834, United States
  • Investigational Site Number 840938
    Lexington, North Carolina 27292, United States
  • Investigational Site Number 840976
    Smithfield, North Carolina 27577, United States
  • Investigational Site Number 840985
    Winston-Salem, North Carolina 27103, United States
  • Investigational Site Number 840963
    Cincinnati, Ohio 45219, United States
  • Investigational Site Number 840970
    Lyndhust, Ohio 44124, United States
  • Investigational Site Number 840906
    Marion, Ohio 43302, United States
  • Investigational Site Number 840997
    Marion, Ohio 43302, United States
  • Investigational Site Number 840964
    Perrysburg, Ohio 43551, United States
  • Investigational Site Number 840913
    Charleston, South Carolina 29412, United States
  • Investigational Site Number 840912
    Greer, South Carolina 29651, United States
  • Investigational Site Number 840992
    Summerville, South Carolina 29485, United States
  • Investigational Site Number 840932
    Bristol, Tennessee 37620, United States
  • Investigational Site Number 840944
    Nashville, Tennessee 37205, United States
  • Investigational Site Number 840994
    Fort Worth, Texas 76104, United States
  • Investigational Site Number 840973
    Houston, Texas 77070, United States
  • Investigational Site Number 840939
    Houston, Texas 77074, United States
  • Investigational Site Number 840945
    Sugar Land, Texas 77479, United States
  • Investigational Site Number 840971
    Tomball, Texas 77375, United States
  • Investigational Site Number 840982
    Orem, Utah 84058, United States
  • Investigational Site Number 840931
    Norfolk, Virginia 23502, United States
  • Investigational Site Number 840984
    Richmond, Virginia 23227, United States
  • Investigational Site Number 840928
    Renton, Washington 98055, United States
  • Investigational Site Number 840990
    Spokane, Washington 99204, United States
  • Investigational Site Number 124902
    Brampton, L6T 3J1, Canada
  • Investigational Site Number 124914
    Mirabel, J7J 2K8, Canada
  • Investigational Site Number 124903
    Montreal, H1T 3Y7, Canada
  • Investigational Site Number 124918
    Toronto, M9V 4B4, Canada
  • Investigational Site Number 208913
    Esbjerg, 6700, Denmark
  • Investigational Site Number 208914
    Glostrup Municipality, 2600, Denmark
  • Investigational Site Number 208905
    Hellerup, 2900, Denmark
  • Investigational Site Number 208911
    Herlev, 2730, Denmark
  • Investigational Site Number 208907
    Hvidovre, 2650, Denmark
  • Investigational Site Number 208901
    København S, 2300, Denmark
  • Investigational Site Number 208906
    Køge, 4600, Denmark
  • Investigational Site Number 208908
    Roskilde, 4000, Denmark
  • Investigational Site Number 208903
    Silkeborg, 8600, Denmark
  • Investigational Site Number 250906
    Dijon, 21079, France
  • Investigational Site Number 250907
    Montpellier, 34295, France
  • Investigational Site Number 250903
    Nantes, 44093, France
  • Investigational Site Number 250905
    Nîmes, 30900, France
  • Investigational Site Number 348908
    Budapest, 1036, Hungary
  • Investigational Site Number 348901
    Budapest, 1134, Hungary
  • Investigational Site Number 348903
    Budapest, 1134, Hungary
  • Investigational Site Number 348905
    Debrecen, 4032, Hungary
  • Investigational Site Number 348906
    Székesfehérvár, 8000, Hungary
  • Investigational Site Number 376908
    Holon, 58100, Israel
  • Investigational Site Number 376903
    Kfar Saba, 44281, Israel
  • Investigational Site Number 376906
    Ofakim, 80300, Israel
  • Investigational Site Number 376902
    Petah Tikva, Israel
  • Investigational Site Number 376904
    Rehovot, 76100, Israel
  • Investigational Site Number 376907
    Safed, 13100, Israel
  • Investigational Site Number 376901
    Tel Aviv, 64239, Israel
  • Investigational Site Number 643906
    Barnaul, 656055, Russia
  • Investigational Site Number 643903
    Kemerovo, 650002, Russia
  • Investigational Site Number 643927
    Moscow, 111539, Russia
  • Investigational Site Number 643928
    Moscow, 111539, Russia
  • Investigational Site Number 643931
    Moscow, 115404, Russia
  • Investigational Site Number 643924
    Moscow, 119048, Russia
  • Investigational Site Number 643932
    Moscow, 121374, Russia
  • Investigational Site Number 643908
    Moscow, 121552, Russia
  • Investigational Site Number 643904
    Moscow, 129090, Russia
  • Investigational Site Number 643911
    Orenburg, 450000, Russia
  • Investigational Site Number 643921
    Ryazan, 390026, Russia
  • Investigational Site Number 643925
    Saint Petersburg, 197110, Russia
  • Investigational Site Number 643922
    Saint Petersburg, 198205, Russia

Showing the first 100 of 126 sites across 10 countries.

09

References and documents

Publications

  • 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. PubMed 25240705 ↗
  • Cannon CP, Cariou B, Blom D, McKenney JM, Lorenzato C, Pordy R, Chaudhari U, Colhoun HM; ODYSSEY COMBO II Investigators. Efficacy and safety of alirocumab in high cardiovascular risk patients with inadequately controlled hypercholesterolaemia on maximally tolerated doses of statins: the ODYSSEY COMBO II randomized controlled trial. Eur Heart J. 2015 May 14;36(19):1186-94. doi: 10.1093/eurheartj/ehv028. Epub 2015 Feb 16. PubMed 25687353 ↗
  • 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. PubMed 34298554 ↗
  • 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. PubMed 30183102 ↗
  • 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. PubMed 27777279 ↗
10

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 2012, a primary completion of May 2014 and a completion of Jul 2015. It does not say whether these dates are actual or estimated.

Results were first posted in Nov 2015, 1 year 6 months after primary completion. A results delay was requested in Feb 2015.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 16, 2012
First posted
Jul 18, 2012
Start
Aug 2012
Primary completionActual
May 2014
CompletionActual
Jul 2015
Results delay requested
Feb 9, 2015
Results first posted
Nov 6, 2015
Last update
Aug 4, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 4, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01644188
Lead sponsor
Sanofi
Collaborators
Regeneron Pharmaceuticals
Responsible party
Sponsor
First posted
Jul 18, 2012
Start date
Aug 2012
Primary completion
May 2014
Completion
Jul 2015
Results posted
Nov 6, 2015
Last update
Aug 4, 2016

Study contacts

Clinical Sciences & Operations
study director · Sanofi

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.

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