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CompletedNCT02642159Updated May 1, 2018Results posted

Efficacy and Safety of Alirocumab Versus Usual Care on Top of Maximally Tolerated Statin Therapy in Patients With Type 2 Diabetes and Mixed Dyslipidemia (ODYSSEY DM-Dyslipidemia)

A Phase 4 interventional study of Alirocumab and Statins in Dyslipidemia, sponsored by Sanofi. Completed at 119 sites in 15 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-05-01.

Sponsored by Sanofi · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
413
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Primary Objective:

To demonstrate the superiority of alirocumab in comparison with usual care in the reduction of non-high-density lipoprotein cholesterol (non-HDL-C) in participants with type 2 diabetes and mixed dyslipidemia at high cardiovascular risk with non-HDL-C not adequately controlled with maximally tolerated statin therapy.

Secondary Objectives:

  • To demonstrate whether alirocumab is superior in comparison with usual care in its effects on other lipid parameters (ie, low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), total cholesterol (Total -C), lipoprotein a (Lp[a]), high-density lipoprotein cholesterol (HDL-C), triglycerides (TGs), triglyceride rich lipoproteins (TGRLs), apolipoprotein A-1 (Apo A-1), apolipoprotein C-III (Apo C-III), lipid subfractions by nuclear magnetic resonance (NMR) spectroscopy (ie, LDL-C particle size and LDL, very low-density lipoprotein [VLDL], HDL, and intermediate-density lipoprotein [IDL] particle number).
  • To assess changes in glycemic parameters with alirocumab vs. usual care treatment.
  • To demonstrate the safety and tolerability of alirocumab.
  • To evaluate treatment acceptance of alirocumab.
  • To evaluate proprotein convertase subtilisin kexin type 9 (PCSK9) concentrations and antibody development.
  • To demonstrate the superiority of alirocumab vs. fenofibrate on non-HDL-C and other lipid parameters (subgroup analysis).
Read the detailed description

The maximum study duration was approximately 9 months per participant, including a 6 month treatment period, a screening period of up to 3 weeks, and an 8 week safety observation period.

For the purpose of scientific communication, a first-step analysis (both efficacy and safety) was performed at the Week 24 cut-off date. A second-step analysis was performed once all participants had completed the study to include a final update of the safety analysis.

02

Conditions studied

  • Dyslipidemia

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03

In context

Dyslipidemias

1,073 studies on the registry are indexed under Dyslipidemias; 158 are open to participants now.

This study's enrollment of 413 is above the median of 99 across 842 interventional studies indexed under Dyslipidemias.

Browse Dyslipidemias studies →

Lead sponsor

Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.

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

Inclusion criteria

  • Participants with type 2 diabetes and mixed dyslipidemia whose non-HDL-C was not adequately controlled with a stable, maximum dose/regimen of statin that was tolerated by the participant.
  • 18 years of age or more.
  • Documented history of atherosclerotic cardiovascular disease (ASCVD) or at least one additional cardiovascular risk factor.
  • Non-HDL-C of 100 mg/dL or greater.
  • Triglycerides greater than or equal to 150 mg/dL and less than 500 mg/dL.
  • Stable anti-hyperglycemic agents for at least 3 months prior to the screening visit and between screening and randomization (including stable insulin dose defined as no variation more than 30% in daily insulin dose within the preceding 3 months, as judged by the Investigator).
  • No change in weight of more than 5 kg within the prior 3 months.
  • On stable dose of medications that are known to influence weight and/or lipids within the last 3 months.

Exclusion criteria

Exclusion criteria:

  • Use of any lipid modifying therapies other than statins within the last 4 weeks (eg, ezetimibe, fenofibrate, nicotinic acid, omega-3 fatty acids, etc.) or use of over the counter products/nutraceuticals known to impact lipids (eg, red yeast rice) within the last 4 weeks.
  • Currently drinking more than 2 standard alcoholic drinks per day.
  • Body Mass Index (BMI) >45 kg/m² or currently enrolled in a weight loss program and still in active phase of weight loss.
  • Glycosylated hemoglobin (HbA1c) 9% or greater.

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 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
413 participants (actual)

Study arms

  • Experimental
    Alirocumab 75 mg Q2W/Up to 150 mg Q2W

    Alirocumab 75 mg subcutaneous (SC) injection every 2 weeks (Q2W) added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other lipid modifying therapy (LMT) for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-high-density lipoprotein cholesterol (non-HDL-C) levels \>=100 mg/dL (2.59 mmol/L) at Week 8.

    Drug: Alirocumab · Drug: Statins · Drug: Antihyperglycemic Drug

  • Active comparator
    Usual Care

    Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without additional LMT or with either ezetimibe, fenofibrate, omega-3 fatty acids or nicotinic acid as per Investigator's judgment for 24 weeks.

    Drug: Statins · Drug: Ezetimibe · Drug: Fenofibrate · Drug: Nicotinic acid · Drug: Omega-3 fatty acids · Drug: Antihyperglycemic Drug

Interventions

  • DrugAlirocumab

    Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with a disposable auto-injector.

    Also known as: SAR236553, REGN727, Praluent

  • DrugStatins

    Statins at stable dose without other LMT as clinically indicated.

  • DrugEzetimibe

    Pharmaceutical form: tablet Route of administration: oral

  • DrugFenofibrate

    Pharmaceutical form: tablet Route of administration: oral

  • DrugNicotinic acid

    Pharmaceutical form: tablet Route of administration: oral

  • DrugOmega-3 fatty acids

    Pharmaceutical form: tablet Route of administration: oral

  • DrugAntihyperglycemic Drug

    Insulin (injectable or inhaled) or other antihyperglycemic drugs as clinically indicated.

06

What researchers measure

Primary outcomes

  1. Percent Change From Baseline in Non-HDL-C at Week 24: Overall 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 8 to Week 24 regardless of status on- or off-treatment were used in the model (ITT analysis).

    Time frame: From Baseline to Week 24

  2. Percent Change From Baseline in Non-HDL-C at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum

    Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate.

    Time frame: From Baseline to Week 24

Secondary outcomes

  1. Percent Change From Baseline in Measured Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24: Overall ITT Analysis

    Measured LDL-C values via beta quantification method. Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment.

    Time frame: From Baseline to Week 24

  2. Percent Change From Baseline in Measured LDL-C at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum

    Measured LDL-C values via beta quantification method. Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate.

    Time frame: From Baseline to Week 24

  3. Percent Change From Baseline in Non-HDL-C at Week 12: Overall ITT Analysis

    Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment.

    Time frame: From Baseline to Week 24

  4. Percent Change From Baseline in Non-HDL-C at Week 12: ITT- Intent to Prescribe Fenofibrate Stratum

    Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate.

    Time frame: From Baseline to Week 24

  5. Percent Change From Baseline in Measured LDL-C at Week 12: Overall ITT Analysis

    Measured LDL-C values via beta quantification method. Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment.

    Time frame: From Baseline to Week 24

  6. Percent Change From Baseline in Measured LDL-C at Week 12: ITT- Intent to Prescribe Fenofibrate Stratum

    Measured LDL-C values via beta quantification method. Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate.

    Time frame: From Baseline to Week 24

  7. Percent Change From Baseline in Apolipoprotein B (Apo-B) at Week 24: Overall ITT Analysis

    Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment.

    Time frame: From Baseline to Week 24

  8. Percent Change From Baseline in Apo B at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum

    Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate.

    Time frame: From Baseline to Week 24

  9. Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 : Overall ITT Analysis

    Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment.

    Time frame: From Baseline to Week 24

  10. Percent Change From Baseline in Total-C at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum

    Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate.

    Time frame: From Baseline to Week 24

  11. Percent Change From Baseline in Lipoprotein(a) at Week 24 : Overall 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 8 to Week 24 regardless of status on- or off-treatment were included in the imputation model.

    Time frame: From Baseline to Week 24

  12. Percent Change From Baseline in Lipoprotein(a) at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum

    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 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate.

    Time frame: From Baseline to Week 24

  13. Percent Change From Baseline in Fasting Triglycerides at Week 24: Overall 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 8 to Week 24 regardless of status on- or off-treatment.

    Time frame: From Baseline to Week 24

  14. Percent Change From Baseline in Fasting Triglycerides at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum

    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 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate.

    Time frame: From Baseline to Week 24

  15. Percent Change From Baseline in HDL-C at Week 24 : Overall ITT Analysis

    Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment.

    Time frame: From Baseline to Week 24

  16. Percent Change From Baseline in HDL-C at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum

    Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate.

    Time frame: From Baseline to Week 24

  17. Percent Change From Baseline in LDL-C Particle Number at Week 24: Overall ITT Analysis

    LDL-C particle number was calculated from lipid subfractions by nuclear magnetic resonance (NMR) spectroscopy. Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment.

    Time frame: From Baseline to Week 24

  18. Percent Change From Baseline in LDL-C Particle Number at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum

    LDL-C particle number was calculated from lipid subfractions by NMR spectroscopy. Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate.

    Time frame: From Baseline to Week 24

  19. Absolute Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12 and 24 : Overall ITT Analysis

    Absolute change = HbA1c value at specified week minus HbA1c value at baseline.

    Time frame: Baseline, Week 12 and 24

  20. Absolute Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12 and 24 : Overall ITT Analysis

    Absolute change = FPG value at specified week minus FPG value at baseline.

    Time frame: Baseline, Week 12 and 24

  21. Absolute Change From Baseline in Number of Glucose-Lowering Treatments at Week 12 and 24 : Overall ITT Analysis

    Glucose lowering treatment was calculated for non-insulin treatments as one for each unique treatment received and for insulin treatment as one in total for all participants who have taken one or more treatments. Absolute change = number of glucose-lowering treatments at specified week minus baseline value.

    Time frame: Baseline, Week 12 and 24

07

Results

Posted May 1, 2018

Participant flow

The study was conducted at 119 centers in 15 countries. A total of 864 participants were screened between March 2016 and September 2016, 451 of whom were screen failures. Screen failures were mainly due to inclusion criteria not met.

Participant flow — Overall Study
MilestoneAlirocumab 75 mg Q2W/Up to 150 mg Q2WUsual Care
Started276137
Treated (safety population)275137
Itt population273136
Itt: intent to prescribe fenofibrate4724
Completed245129
Not completed318
Withdrew: Randomized but not treated10
Withdrew: Adverse event104
Withdrew: Withdrawal by subject91
Withdrew: Poor compliance to study protocol10
Withdrew: Other than specified above103

Outcome measures

PrimaryPercent Change From Baseline in Non-HDL-C at Week 24: Overall 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 8 to Week 24 regardless of status on- or off-treatment were used in the model (ITT analysis).

Time frame:
From Baseline to Week 24
Reported as:
Least squares mean · Percent change
Percent Change From Baseline in Non-HDL-C at Week 24: Overall Intent-to-treat (ITT) Analysis
Percent changeAlirocumab 75 mg Q2W/Up to 150 mg Q2WUsual Care
Percent Change From Baseline in Non-HDL-C at Week 24: Overall Intent-to-treat (ITT) Analysis-37.3 ± 3.0-4.7 ± 3.3
Statistical analysis
  • Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs Usual Care · Mixed Models Analysis · p = <0.0001 (Threshold for significance \<=0.025.) · Ls mean difference: -32.5 · 97.5% CI -38.1 to -27.0Alirocumab vs. usual care
PrimaryPercent Change From Baseline in Non-HDL-C at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum

Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate.

Time frame:
From Baseline to Week 24
Reported as:
Least squares mean · Percent change
Percent Change From Baseline in Non-HDL-C at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum
Percent changeAlirocumab 75 mg Q2W/Up to 150 mg Q2WUsual Care: Intent to Prescribe Fenofibrate
Percent Change From Baseline in Non-HDL-C at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum-41.7 ± 3.4-8.5 ± 4.8
Statistical analysis
  • Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs Usual Care: Intent to Prescribe Fenofibrate · Mixed Models Analysis · p = <0.0001 (Threshold for significance \<=0.025.) · Ls mean difference: -33.3 · 97.5% CI -46.6 to -19.9Alirocumab (intent to prescribe fenofibrate) vs. usual care (intent to prescribe fenofibrate)
SecondaryPercent Change From Baseline in Measured Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24: Overall ITT Analysis

Measured LDL-C values via beta quantification method. Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment.

Time frame:
From Baseline to Week 24
Reported as:
Least squares mean · Percent change
Percent Change From Baseline in Measured Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24: Overall ITT Analysis
Percent changeAlirocumab 75 mg Q2W/Up to 150 mg Q2WUsual Care
Percent Change From Baseline in Measured Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24: Overall ITT Analysis-43.3 ± 3.6-0.3 ± 4.0
Statistical analysis
  • Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs Usual Care · Mixed Models Analysis · p = <0.0001 (Threshold for significance \<=0.025.) · Ls mean difference: -43.0 · 97.5% CI -49.7 to -36.3Alirocumab vs. usual care
SecondaryPercent Change From Baseline in Measured LDL-C at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum

Measured LDL-C values via beta quantification method. Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate.

Time frame:
From Baseline to Week 24
Reported as:
Least squares mean · Percent change
Percent Change From Baseline in Measured LDL-C at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum
Percent changeAlirocumab 75 mg Q2W/Up to 150 mg Q2WUsual Care: Intent to Prescribe Fenofibrate
Percent Change From Baseline in Measured LDL-C at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum-47.0 ± 4.28.7 ± 5.8
Statistical analysis
  • Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs Usual Care: Intent to Prescribe Fenofibrate · Mixed Models Analysis · p = <0.0001 (Threshold for significance \<=0.025.) · Ls mean difference: -55.7 · 97.5% CI -71.8 to -39.6Alirocumab (intent to prescribe fenofibrate) vs. usual care (intent to prescribe fenofibrate)
SecondaryPercent Change From Baseline in Non-HDL-C at Week 12: Overall ITT Analysis

Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment.

Time frame:
From Baseline to Week 24
Reported as:
Least squares mean · Percent change
Percent Change From Baseline in Non-HDL-C at Week 12: Overall ITT Analysis
Percent changeAlirocumab 75 mg Q2W/Up to 150 mg Q2WUsual Care
Percent Change From Baseline in Non-HDL-C at Week 12: Overall ITT Analysis-35.5 ± 2.9-9.4 ± 3.2
Statistical analysis
  • Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs Usual Care · Mixed Models Analysis · p = <0.0001 (Threshold for significance \<=0.025.) · Ls mean difference: -26.1 · 97.5% CI -31.5 to -20.7Alirocumab vs. usual care
SecondaryPercent Change From Baseline in Non-HDL-C at Week 12: ITT- Intent to Prescribe Fenofibrate Stratum

Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate.

Time frame:
From Baseline to Week 24
Reported as:
Least squares mean · Percent change
Percent Change From Baseline in Non-HDL-C at Week 12: ITT- Intent to Prescribe Fenofibrate Stratum
Percent changeAlirocumab 75 mg Q2W/Up to 150 mg Q2WUsual Care: Intent to Prescribe Fenofibrate
Percent Change From Baseline in Non-HDL-C at Week 12: ITT- Intent to Prescribe Fenofibrate Stratum-34.7 ± 3.2-7.3 ± 4.5
Statistical analysis
  • Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs Usual Care: Intent to Prescribe Fenofibrate · Mixed Models Analysis · p = <0.0001 (Threshold for significance \<=0.025.) · Ls mean difference: -27.4 · 97.5% CI -40.0 to -14.8Alirocumab (intent to prescribe fenofibrate) vs. usual care (intent to prescribe fenofibrate)
SecondaryPercent Change From Baseline in Measured LDL-C at Week 12: Overall ITT Analysis

Measured LDL-C values via beta quantification method. Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment.

Time frame:
From Baseline to Week 24
Reported as:
Least squares mean · Percent change
Percent Change From Baseline in Measured LDL-C at Week 12: Overall ITT Analysis
Percent changeAlirocumab 75 mg Q2W/Up to 150 mg Q2WUsual Care
Percent Change From Baseline in Measured LDL-C at Week 12: Overall ITT Analysis-41.7 ± 3.3-7.0 ± 3.6
Statistical analysis
  • Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs Usual Care · Mixed Models Analysis · p = <0.0001 (Threshold for significance \<=0.025.) · Ls mean difference: -34.7 · 97.5% CI -40.8 to -28.6Alirocumab vs. usual care
SecondaryPercent Change From Baseline in Measured LDL-C at Week 12: ITT- Intent to Prescribe Fenofibrate Stratum

Measured LDL-C values via beta quantification method. Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate.

Time frame:
From Baseline to Week 24
Reported as:
Least squares mean · Percent change
Percent Change From Baseline in Measured LDL-C at Week 12: ITT- Intent to Prescribe Fenofibrate Stratum
Percent changeAlirocumab 75 mg Q2W/Up to 150 mg Q2WUsual Care: Intent to Prescribe Fenofibrate
Percent Change From Baseline in Measured LDL-C at Week 12: ITT- Intent to Prescribe Fenofibrate Stratum-44.3 ± 3.65.4 ± 5.1
Statistical analysis
  • Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs Usual Care: Intent to Prescribe Fenofibrate · Mixed Models Analysis · p = <0.0001 (Threshold for significance \<=0.025.) · Ls mean difference: -49.7 · 97.5% CI -63.7 to -35.8Alirocumab (intent to prescribe fenofibrate) vs. usual care (intent to prescribe fenofibrate)
SecondaryPercent Change From Baseline in Apolipoprotein B (Apo-B) at Week 24: Overall ITT Analysis

Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment.

Time frame:
From Baseline to Week 24
Reported as:
Least squares mean · Percent change
Percent Change From Baseline in Apolipoprotein B (Apo-B) at Week 24: Overall ITT Analysis
Percent changeAlirocumab 75 mg Q2W/Up to 150 mg Q2WUsual Care
Percent Change From Baseline in Apolipoprotein B (Apo-B) at Week 24: Overall ITT Analysis-33.8 ± 2.7-1.6 ± 3.0
Statistical analysis
  • Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs Usual Care · Mixed Models Analysis · p = <0.0001 (Threshold for significance \<=0.025.) · Ls mean difference: -32.3 · 97.5% CI -37.3 to -27.2Alirocumab vs. usual care
SecondaryPercent Change From Baseline in Apo B at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum

Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate.

Time frame:
From Baseline to Week 24
Reported as:
Least squares mean · Percent change
Percent Change From Baseline in Apo B at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum
Percent changeAlirocumab 75 mg Q2W/Up to 150 mg Q2WUsual Care: Intent to Prescribe Fenofibrate
Percent Change From Baseline in Apo B at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum-38.9 ± 3.1-3.8 ± 4.4
Statistical analysis
  • Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs Usual Care: Intent to Prescribe Fenofibrate · Mixed Models Analysis · p = <0.0001 (Threshold for significance \<=0.025.) · Ls mean difference: -35.2 · 97.5% CI -47.4 to -22.9Alirocumab (intent to prescribe fenofibrate) vs. usual care (intent to prescribe fenofibrate)
SecondaryPercent Change From Baseline in Total Cholesterol (Total-C) at Week 24 : Overall ITT Analysis

Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment.

Time frame:
From Baseline to Week 24
Reported as:
Least squares mean · Percent change
Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 : Overall ITT Analysis
Percent changeAlirocumab 75 mg Q2W/Up to 150 mg Q2WUsual Care
Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 : Overall ITT Analysis-27.4 ± 2.3-2.8 ± 2.5
Statistical analysis
  • Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs Usual Care · Mixed Models Analysis · p = <0.0001 (Threshold for significance \<=0.025.) · Ls mean difference: -24.6 · 97.5% CI -28.8 to -20.3Alirocumab vs. usual care
SecondaryPercent Change From Baseline in Total-C at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum

Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate.

Time frame:
From Baseline to Week 24
Reported as:
Least squares mean · Percent change
Percent Change From Baseline in Total-C at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum
Percent changeAlirocumab 75 mg Q2W/Up to 150 mg Q2WUsual Care: Intent to Prescribe Fenofibrate
Percent Change From Baseline in Total-C at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum-30.9 ± 2.6-5.7 ± 3.7
Statistical analysis
  • Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs Usual Care: Intent to Prescribe Fenofibrate · Mixed Models Analysis · p = <0.0001 (Threshold for significance \<=0.025.) · Ls mean difference: -25.3 · 97.5% CI -35.4 to -15.1Alirocumab (intent to prescribe fenofibrate) vs. usual care (intent to prescribe fenofibrate)
SecondaryPercent Change From Baseline in Lipoprotein(a) at Week 24 : Overall 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 8 to Week 24 regardless of status on- or off-treatment were included in the imputation model.

Time frame:
From Baseline to Week 24
Reported as:
Mean · Percent change
Percent Change From Baseline in Lipoprotein(a) at Week 24 : Overall ITT Analysis
Percent changeAlirocumab 75 mg Q2W/Up to 150 mg Q2WUsual Care
Percent Change From Baseline in Lipoprotein(a) at Week 24 : Overall ITT Analysis-23.7 ± 1.93.7 ± 2.6
Statistical analysis
  • Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs Usual Care · Regression, Robust · p = <0.0001 (Threshold for significance \<=0.025.) · Adjusted mean difference: -27.4 · 97.5% CI -34.6 to -20.1Alirocumab vs. usual care
SecondaryPercent Change From Baseline in Lipoprotein(a) at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum

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 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate.

Time frame:
From Baseline to Week 24
Reported as:
Mean · Percent change
Percent Change From Baseline in Lipoprotein(a) at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum
Percent changeAlirocumab 75 mg Q2W/Up to 150 mg Q2WUsual Care: Intent to Prescribe Fenofibrate
Percent Change From Baseline in Lipoprotein(a) at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum-18.9 ± 4.43.9 ± 6.6
Statistical analysis
  • Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs Usual Care: Intent to Prescribe Fenofibrate · Regression, Robust · p = 0.0040 (Threshold for significance \<=0.025.) · Adjusted mean difference: -22.8 · 97.5% CI -40.6 to -5.0Alirocumab (intent to prescribe fenofibrate) vs. usual care (intent to prescribe fenofibrate)
SecondaryPercent Change From Baseline in Fasting Triglycerides at Week 24: Overall 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 8 to Week 24 regardless of status on- or off-treatment.

Time frame:
From Baseline to Week 24
Reported as:
Mean · Percent change
Percent Change From Baseline in Fasting Triglycerides at Week 24: Overall ITT Analysis
Percent changeAlirocumab 75 mg Q2W/Up to 150 mg Q2WUsual Care
Percent Change From Baseline in Fasting Triglycerides at Week 24: Overall ITT Analysis-13.0 ± 2.0-8.8 ± 2.8
Statistical analysis
  • Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs Usual Care · Regression, Robust · p = 0.2191 (Threshold for significance \<=0.025.) · Adjusted mean difference: -4.2 · 97.5% CI -11.8 to 3.4Alirocumab vs. usual care
SecondaryPercent Change From Baseline in Fasting Triglycerides at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum

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 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate.

Time frame:
From Baseline to Week 24
Reported as:
Mean · Percent change
Percent Change From Baseline in Fasting Triglycerides at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum
Percent changeAlirocumab 75 mg Q2W/Up to 150 mg Q2WUsual Care: Intent to Prescribe Fenofibrate
Percent Change From Baseline in Fasting Triglycerides at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum-15.4 ± 4.7-24.4 ± 6.6
Statistical analysis
  • Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs Usual Care: Intent to Prescribe Fenofibrate · Regression, Robust · p = 0.2651 (Threshold for significance \<=0.025.) · Adjusted mean difference: 9.0 · 97.5% CI -9.1 to 27.1Multiple imputation approach followed by robust regression.
SecondaryPercent Change From Baseline in HDL-C at Week 24 : Overall ITT Analysis

Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment.

Time frame:
From Baseline to Week 24
Reported as:
Least squares mean · Percent change
Percent Change From Baseline in HDL-C at Week 24 : Overall ITT Analysis
Percent changeAlirocumab 75 mg Q2W/Up to 150 mg Q2WUsual Care
Percent Change From Baseline in HDL-C at Week 24 : Overall ITT Analysis14.5 ± 2.58.2 ± 2.7
SecondaryPercent Change From Baseline in HDL-C at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum

Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate.

Time frame:
From Baseline to Week 24
Reported as:
Least squares mean · Percent change
Percent Change From Baseline in HDL-C at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum
Percent changeAlirocumab 75 mg Q2W/Up to 150 mg Q2WUsual Care: Intent to Prescribe Fenofibrate
Percent Change From Baseline in HDL-C at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum13.5 ± 2.912.3 ± 4.1
SecondaryPercent Change From Baseline in LDL-C Particle Number at Week 24: Overall ITT Analysis

LDL-C particle number was calculated from lipid subfractions by nuclear magnetic resonance (NMR) spectroscopy. Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment.

Time frame:
From Baseline to Week 24
Reported as:
Least squares mean · Percent change
Percent Change From Baseline in LDL-C Particle Number at Week 24: Overall ITT Analysis
Percent changeAlirocumab 75 mg Q2W/Up to 150 mg Q2WUsual Care
Percent Change From Baseline in LDL-C Particle Number at Week 24: Overall ITT Analysis-41.6 ± 3.0-3.9 ± 3.4
SecondaryPercent Change From Baseline in LDL-C Particle Number at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum

LDL-C particle number was calculated from lipid subfractions by NMR spectroscopy. Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate.

Time frame:
From Baseline to Week 24
Reported as:
Least squares mean · Percent change
Percent Change From Baseline in LDL-C Particle Number at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum
Percent changeAlirocumab 75 mg Q2W/Up to 150 mg Q2WUsual Care: Intent to Prescribe Fenofibrate
Percent Change From Baseline in LDL-C Particle Number at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum-45.4 ± 3.5-2.9 ± 5.0
SecondaryAbsolute Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12 and 24 : Overall ITT Analysis

Absolute change = HbA1c value at specified week minus HbA1c value at baseline.

Time frame:
Baseline, Week 12 and 24
Reported as:
Mean · mmol/mol
Absolute Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12 and 24 : Overall ITT Analysis
mmol/molAlirocumab 75 mg Q2W/Up to 150 mg Q2WUsual Care
Change at Week 120.59 ± 6.820.43 ± 5.70
Change at Week 242.84 ± 8.042.40 ± 8.19
SecondaryAbsolute Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12 and 24 : Overall ITT Analysis

Absolute change = FPG value at specified week minus FPG value at baseline.

Time frame:
Baseline, Week 12 and 24
Reported as:
Mean · mmol/L
Absolute Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12 and 24 : Overall ITT Analysis
mmol/LAlirocumab 75 mg Q2W/Up to 150 mg Q2WUsual Care
Change at Week 120.45 ± 2.430.21 ± 1.86
Change at Week 240.68 ± 2.540.03 ± 2.54
SecondaryAbsolute Change From Baseline in Number of Glucose-Lowering Treatments at Week 12 and 24 : Overall ITT Analysis

Glucose lowering treatment was calculated for non-insulin treatments as one for each unique treatment received and for insulin treatment as one in total for all participants who have taken one or more treatments. Absolute change = number of glucose-lowering treatments at specified week minus baseline value.

Time frame:
Baseline, Week 12 and 24
Reported as:
Mean · Glucose lowering treatments
Absolute Change From Baseline in Number of Glucose-Lowering Treatments at Week 12 and 24 : Overall ITT Analysis
Glucose lowering treatmentsAlirocumab 75 mg Q2W/Up to 150 mg Q2WUsual Care
Change at Week 120.04 ± 0.300.04 ± 0.19
Change at Week 240.07 ± 0.370.04 ± 0.23

Adverse events

Collected over All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 32) regardless of seriousness or relationship to investigational product.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Alirocumab 75 mg Q2W/Up to 150 mg Q2W1/275 (0.4%)26/275 (9.5%)37/275 (13.5%)
Usual Care0/137 (0%)12/137 (8.8%)27/137 (19.7%)
Most frequent serious events
Showing 10 of 31
Most frequent serious events
EventAlirocumab 75 mg Q2W/Up to 150 mg Q2WUsual Care
Ischaemic strokeNervous system disorders2/2752/137
Angina unstableCardiac disorders3/2750/137
Acute myocardial infarctionCardiac disorders1/2751/137
Cholecystitis acuteHepatobiliary disorders0/2751/137
Diabetes mellitus inadequate controlMetabolism and nutrition disorders0/2751/137
Back painMusculoskeletal and connective tissue disorders0/2751/137
Spinal osteoarthritisMusculoskeletal and connective tissue disorders0/2751/137
Cerebrovascular accidentNervous system disorders0/2751/137
DizzinessNervous system disorders0/2751/137
Facial paralysisNervous system disorders0/2751/137
Most frequent other events
Most frequent other events
EventAlirocumab 75 mg Q2W/Up to 150 mg Q2WUsual Care
DiarrhoeaGastrointestinal disorders14/2759/137
ArthralgiaMusculoskeletal and connective tissue disorders6/2758/137
Urinary tract infectionInfections and infestations15/2755/137
BronchitisInfections and infestations5/2757/137

Baseline characteristics

Baseline population included all randomized participants.

Age, Continuous
Age, Continuous(years)Alirocumab 75 mg Q2W/Up to 150 mg Q2WUsual CareTotal
Mean62.8 ± 9.364.1 ± 8.863.2 ± 9.2
Sex: Female, Male
Sex: Female, Male(Participants)Alirocumab 75 mg Q2W/Up to 150 mg Q2WUsual CareTotal
Female12968197
Male14769216
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Alirocumab 75 mg Q2W/Up to 150 mg Q2WUsual CareTotal
Hispanic or Latino351449
Not Hispanic or Latino240123363
Unknown or Not Reported101
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Alirocumab 75 mg Q2W/Up to 150 mg Q2WUsual CareTotal
White/Caucasian247123370
Black16622
Asian/Oriental3710
American Indian or Alaska Native404
Native Hawaiian or Other Pacific Islander000
Other617
Non-HDL-C
Non-HDL-C(mg/dL)Alirocumab 75 mg Q2W/Up to 150 mg Q2WUsual CareTotal
Mean155.1 ± 46.2161.5 ± 48.8157.2 ± 47.1
Non-HDL-C
Non-HDL-C(mmol/L)Alirocumab 75 mg Q2W/Up to 150 mg Q2WUsual CareTotal
Mean4.0 ± 1.24.2 ± 1.24.073 ± 1.221
Intent to Prescribe Treatment
Intent to Prescribe Treatment(Participants)Alirocumab 75 mg Q2W/Up to 150 mg Q2WUsual CareTotal
Fenofibrate482472
No additional LMT7939118
Ezetimibe10452156
Omega-3 fatty acids432164
Nicotinic acid213
08

Study locations

119 sites
  • Investigational Site Number 840-163
    Little Rock, Arkansas 72205, United States
  • Investigational Site Number 840-141
    Fresno, California 93720, United States
  • Investigational Site Number 840-152
    Huntington Beach, California 92648, United States
  • Investigational Site Number 840-115
    La Jolla, California 92037, United States
  • Investigational Site Number 840-118
    Los Angeles, California 90057, United States
  • Investigational Site Number 840-106
    Northridge, California 91325, United States
  • Investigational Site Number 840-176
    Port Hueneme, California 93041, United States
  • Investigational Site Number 840-122
    Tarzana, California 91356, United States
  • Investigational Site Number 840-156
    Tustin, California 92780-6953, United States
  • Investigational Site Number 840-160
    Van Nuys, California 91405, United States
  • Investigational Site Number 840-107
    Boca Raton, Florida 33434, United States
  • Investigational Site Number 840-170
    Boynton Beach, Florida 33472, United States
  • Investigational Site Number 840-114
    Bradenton, Florida 34201, United States
  • Investigational Site Number 840-132
    Ocoee, Florida 34761, United States
  • Investigational Site Number 840-179
    Oviedo, Florida 32765, United States
  • Investigational Site Number 840-123
    Tampa, Florida 33634, United States
  • Investigational Site Number 840-137
    Bainbridge, Georgia 39819, United States
  • Investigational Site Number 840-128
    Columbus, Georgia 31904, United States
  • Investigational Site Number 840-169
    Stockbridge, Georgia 30281, United States
  • Investigational Site Number 840-167
    Idaho Falls, Idaho 83404, United States
  • Investigational Site Number 840-161
    Chicago, Illinois 60607, United States
  • Investigational Site Number 840-184
    Crystal Lake, Illinois 60012, United States
  • Investigational Site Number 840-174
    Evanston, Illinois 60201, United States
  • Investigational Site Number 840-138
    Springfield, Illinois 62711, United States
  • Investigational Site Number 840-108
    Louisville, Kentucky, United States
  • Investigational Site Number 840-183
    Paducah, Kentucky 42003, United States
  • Investigational Site Number 840-190
    Metairie, Louisiana 70006, United States
  • Investigational Site Number 840-151
    Rockville, Maryland 20852, United States
  • Investigational Site Number 840-113
    Jefferson City, Missouri 65109, United States
  • Investigational Site Number 840-120
    Saint Louis, Missouri 63110, United States
  • Investigational Site Number 840-148
    Omaha, Nebraska 68131-2137, United States
  • Investigational Site Number 840-101
    Las Vegas, Nevada 89119, United States
  • Investigational Site Number 840-140
    Las Vegas, Nevada 89128, United States
  • Investigational Site Number 840-178
    Albany, New York 12206, United States
  • Investigational Site Number 840-181
    New York, New York 10016, United States
  • Investigational Site Number 840-157
    New York, New York 10029, United States
  • Investigational Site Number 840-188
    Greensboro, North Carolina 27408, United States
  • Investigational Site Number 840-131
    Morehead City, North Carolina 28557, United States
  • Investigational Site Number 840-158
    Morganton, North Carolina 28655, United States
  • Investigational Site Number 840-129
    Fargo, North Dakota 58103, United States
  • Investigational Site Number 840-104
    Columbus, Ohio 43213, United States
  • Investigational Site Number 840-105
    Marion, Ohio 43302, United States
  • Investigational Site Number 840-175
    Maumee, Ohio 43537, United States
  • Investigational Site Number 840-136
    Bend, Oregon 97702, United States
  • Investigational Site Number 840-187
    Murrells Inlet, South Carolina 29576-9351, United States
  • Investigational Site Number 840-111
    Summerville, South Carolina 29485, United States
  • Investigational Site Number 840-147
    Chattanooga, Tennessee 37404, United States
  • Investigational Site Number 840-159
    Knoxville, Tennessee 37920, United States
  • Investigational Site Number 840-153
    Dallas, Texas 75230, United States
  • Investigational Site Number 840-143
    Houston, Texas 77095, United States
  • Investigational Site Number 840-168
    Houston, Texas 77099, United States
  • Investigational Site Number 840-142
    Round Rock, Texas 78681, United States
  • Investigational Site Number 840-133
    Tomball, Texas 77375, United States
  • Investigational Site Number 840-185
    Orem, Utah 84058, United States
  • Investigational Site Number 840-150
    Salt Lake City, Utah 84102, United States
  • Investigational Site Number 840-126
    Chesapeake, Virginia 23321, United States
  • Investigational Site Number 840-171
    Richmond, Virginia 23249, United States
  • Investigational Site Number 036102
    Herston, 4006, Australia
  • Investigational Site Number 036104
    Merewether, 2291, Australia
  • Investigational Site Number 036101
    St Leonards, 2065, Australia
  • Investigational Site Number 076103
    Campinas, 13060080, Brazil
  • Investigational Site Number 076104
    Fortaleza, 60115-282, Brazil
  • Investigational Site Number 076101
    Sao Paulo, 04040-001, Brazil
  • Investigational Site Number 076105
    São paulo, 01223-001, Brazil
  • Investigational Site Number 076106
    São Paulo, 05403-900, Brazil
  • Investigational Site Number 076102
    SãO Paulo, Brazil
  • Investigational Site Number 246102
    Oulu, 90100, Finland
  • Investigational Site Number 246101
    Oulu, 90220, Finland
  • Investigational Site Number 246104
    Tampere, 33520, Finland
  • Investigational Site Number 276112
    Berlin, 13347, Germany
  • Investigational Site Number 276109
    Berlin, 13353, Germany
  • Investigational Site Number 276104
    Dippoldiswalde, 01744, Germany
  • Investigational Site Number 276101
    Dresden, 01307, Germany
  • Investigational Site Number 276110
    Essen, 45355, Germany
  • Investigational Site Number 276108
    Essen, 45359, Germany
  • Investigational Site Number 276111
    Goch, 47574, Germany
  • Investigational Site Number 276107
    Karlsruhe, 76199, Germany
  • Investigational Site Number 276103
    Künzing, 94550, Germany
  • Investigational Site Number 276102
    Oldenburg in Holstein, 23758, Germany
  • Investigational Site Number 376101
    Beer Sheva, Israel
  • Investigational Site Number 376103
    Petach Tikva, Israel
  • Investigational Site Number 376104
    Petach tikva, Israel
  • Investigational Site Number 376102
    Rehovot, Israel
  • Investigational Site Number 376106
    Tel-Aviv, Israel
  • Investigational Site Number 380104
    Bergamo, 24127, Italy
  • Investigational Site Number 380107
    Catanzaro, 88100, Italy
  • Investigational Site Number 380103
    Napoli, 80131, Italy
  • Investigational Site Number 380108
    Padova, 35100, Italy
  • Investigational Site Number 380106
    Partinico, 90047, Italy
  • Investigational Site Number 380101
    Pisa, 56124, Italy
  • Investigational Site Number 380105
    Roma, 00168, Italy
  • Investigational Site Number 380102
    Torino, 10126, Italy
  • Investigational Site Number 414101
    Kuwait, Kuwait
  • Investigational Site Number 422101
    Beirut, Lebanon
  • Investigational Site Number 422102
    Hazmieh, Lebanon
  • Investigational Site Number 578101
    Oslo, 0372, Norway
  • Investigational Site Number 578102
    Oslo, 0407, Norway
  • Investigational Site Number 752102
    Göteborg, 41345, Sweden
  • Investigational Site Number 752101
    Stockholm, 14186, Sweden
  • Investigational Site Number 756101
    Genève, 1205, Switzerland

Showing the first 100 of 119 sites across 15 countries.

09

References and documents

Publications

  • Schmidt AF, Carter JL, Pearce LS, Wilkins JT, Overington JP, Hingorani AD, Casas JP. PCSK9 monoclonal antibodies for the primary and secondary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2020 Oct 20;10(10):CD011748. doi: 10.1002/14651858.CD011748.pub3. PubMed 33078867 ↗
  • Colhoun HM, Leiter LA, Muller-Wieland D, Cariou B, Ray KK, Tinahones FJ, Domenger C, Letierce A, Israel M, Samuel R, Del Prato S. Effect of alirocumab on individuals with type 2 diabetes, high triglycerides, and low high-density lipoprotein cholesterol. Cardiovasc Diabetol. 2020 Feb 8;19(1):14. doi: 10.1186/s12933-020-0991-1. PubMed 32035487 ↗
  • Ray KK, Del Prato S, Muller-Wieland D, Cariou B, Colhoun HM, Tinahones FJ, Domenger C, Letierce A, Mandel J, Samuel R, Bujas-Bobanovic M, Leiter LA. Alirocumab therapy in individuals with type 2 diabetes mellitus and atherosclerotic cardiovascular disease: analysis of the ODYSSEY DM-DYSLIPIDEMIA and DM-INSULIN studies. Cardiovasc Diabetol. 2019 Nov 9;18(1):149. doi: 10.1186/s12933-019-0951-9. PubMed 31706300 ↗
  • Ray KK, Leiter LA, Muller-Wieland D, Cariou B, Colhoun HM, Henry RR, Tinahones FJ, Bujas-Bobanovic M, Domenger C, Letierce A, Samuel R, Del Prato S. Alirocumab vs usual lipid-lowering care as add-on to statin therapy in individuals with type 2 diabetes and mixed dyslipidaemia: The ODYSSEY DM-DYSLIPIDEMIA randomized trial. Diabetes Obes Metab. 2018 Jun;20(6):1479-1489. doi: 10.1111/dom.13257. Epub 2018 Mar 23. PubMed 29436756 ↗
  • Muller-Wieland D, Leiter LA, Cariou B, Letierce A, Colhoun HM, Del Prato S, Henry RR, Tinahones FJ, Aurand L, Maroni J, Ray KK, Bujas-Bobanovic M. Design and rationale of the ODYSSEY DM-DYSLIPIDEMIA trial: lipid-lowering efficacy and safety of alirocumab in individuals with type 2 diabetes and mixed dyslipidaemia at high cardiovascular risk. Cardiovasc Diabetol. 2017 May 25;16(1):70. doi: 10.1186/s12933-017-0552-4. PubMed 28545518 ↗

Study documents

  • Study protocol · Nov 18, 2015
  • Statistical analysis plan · Apr 26, 2017

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 1, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02642159
Lead sponsor
Sanofi
Collaborators
Regeneron Pharmaceuticals
Responsible party
Sponsor
First posted
Dec 30, 2015
Start date
Mar 15, 2016
Primary completion
Mar 22, 2017
Completion
May 15, 2017
Results posted
May 1, 2018
Last update
May 1, 2018

Study contacts

Clinical Sciences & Operations
study director · Sanofi

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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