Trial · NCT01507831
Long-term Safety and Tolerability of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY Long Term)
NCT01507831, Phase 3, Completed, Sanofi; results first posted 2015-12-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Long-term Safety and Tolerability of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY Long Term). Trials, record NCT01507831. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01507831
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long-term Safety and Tolerability of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY Long Term)
- NCT number
- NCT01507831
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,341 participants, actual
- Lead sponsor
- Sanofi
- Conditions
- Hypercholesterolemia
- Interventions
- Placebo (for alirocumab), Alirocumab, Lipid-Modifying Therapy (LMT)
- First posted
- 2012-01-11
- Last updated
- 2015-12-22
- Other registries' IDs
- eudract:2011-002806-59
- Results first posted
- 2015-12-22
- 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 (eCRF) form.
Source ClinicalTrials.gov
Registered outcomes31
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Experienced Adverse Events (AEs) | Up to 10 weeks after last study drug administration (maximum of 86 weeks) | Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days). |
| Secondary | Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis | From Baseline to Week 52 | 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). |
| Secondary | Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis | From Baseline to Week 52 | Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection) (on-treatment analysis). |
| Secondary | Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis | From Baseline to Week 52 | Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment. |
| Secondary | Percent Change From Baseline in Calculated LDL-C at Week 12 - On-treatment Analysis | From Baseline to Week 52 | 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). |
| Secondary | Percent Change From Baseline in Measured LDL-C at Week 24 - ITT Analysis | From Baseline to Week 52 | 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 4 to Week 52 regardless of status on- or off-treatment. |
| Secondary | Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis | From Baseline to Week 52 | 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. |
| Secondary | Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis | From Baseline to Week 52 | 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). |
| Secondary | Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis | From Baseline to Week 52 | 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. |
| Secondary | Percent Change From Baseline in Non-HDL-C at Week 24 - On-Treatment Analysis | From Baseline to Week 52 | 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). |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 registered outcomesOutcomes32
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Who Experienced Adverse Events (AEs) | Up to 10 weeks after last study drug administration (maximum of 86 weeks) | Safety population: all randomized participants who received at least one dose or part of a dose of a study drug (treated). | percentage of participants | NUMBER |
| SECONDARY | Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis | From Baseline to Week 52 | ITT population: all randomized participants with one baseline and at least one post-baseline calculated LDL-C value on- or off-treatment. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis | From Baseline to Week 52 | Modified ITT (mITT) population: all randomized and treated participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis | From Baseline to Week 52 | ITT population. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Calculated LDL-C at Week 12 - On-treatment Analysis | From Baseline to Week 52 | mITT population. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Measured LDL-C at Week 24 - ITT Analysis | From Baseline to Week 52 | Participants of the ITT population with one baseline and at least one post-baseline measured LDL-C value on- or off-treatment. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis | From Baseline to Week 52 | Participants of the ITT population with one baseline and at least one post-baseline Apo B value on- or off-treatment (Apo B ITT population). | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis | From Baseline to Week 52 | Participants of the mITT population with one baseline and at least one post-baseline Apo-B value on-treatment (Apo B mITT population). | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis | From Baseline to Week 52 | Participants of the ITT population with one baseline and at least one post-baseline non-HDL-C value on- or off-treatment (non-HDL-C ITT population). | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Non-HDL-C at Week 24 - On-Treatment Analysis | From Baseline to Week 52 | Participants of the mITT population with one baseline and at least one post-baseline non-HDL-C value on-treatment (non-HDL-C mITT population). | percent change | LEAST_SQUARES_MEAN |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 outcomesResults by group70
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Who Experienced Adverse Events (AEs) | Placebo Q2W | Any AE | 82.5 | percentage of participants | |
| Percentage of Participants Who Experienced Adverse Events (AEs) | Alirocumab 150 mg Q2W | Any AE | 81.0 | percentage of participants | |
| Percentage of Participants Who Experienced Adverse Events (AEs) | Placebo Q2W | Any Serious AE | 19.5 | percentage of participants | |
| Percentage of Participants Who Experienced Adverse Events (AEs) | Alirocumab 150 mg Q2W | Any Serious AE | 18.7 | percentage of participants | |
| Percentage of Participants Who Experienced Adverse Events (AEs) | Placebo Q2W | Any AE leading to death | 1.3 | percentage of participants | |
| Percentage of Participants Who Experienced Adverse Events (AEs) | Alirocumab 150 mg Q2W | Any AE leading to death | 0.5 | percentage of participants | |
| Percentage of Participants Who Experienced Adverse Events (AEs) | Placebo Q2W | Any AE leading to treatment discontinuation | 5.8 | percentage of participants | |
| Percentage of Participants Who Experienced Adverse Events (AEs) | Alirocumab 150 mg Q2W | Any AE leading to treatment discontinuation | 7.2 | percentage of participants | |
| Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis | Placebo Q2W | 0.8 | Standard Error 1.0 | percent change | |
| Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis | Alirocumab 150 mg Q2W | -61.0 | Standard Error 0.7 | percent change |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo Q2W | 788 | |
| Overall Study | STARTED | Alirocumab 150 mg Q2W | 1,553 | |
| Overall Study | Treated | Placebo Q2W | 788 | |
| Overall Study | Treated | Alirocumab 150 mg Q2W | 1,550 | |
| Overall Study | COMPLETED | Placebo Q2W | 595 | |
| Overall Study | COMPLETED | Alirocumab 150 mg Q2W | 1,113 | |
| Overall Study | NOT COMPLETED | Placebo Q2W | 193 | |
| Overall Study | NOT COMPLETED | Alirocumab 150 mg Q2W | 440 |
Source ClinicalTrials.gov
Adverse events688
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nasopharyngitis | Infections and infestations | Placebo Q2W | 103 | 788 | |
| other | Nasopharyngitis | Infections and infestations | Alirocumab 150 mg Q2W | 209 | 1,550 | |
| other | Upper respiratory tract infection | Infections and infestations | Placebo Q2W | 68 | 788 | |
| other | Upper respiratory tract infection | Infections and infestations | Alirocumab 150 mg Q2W | 114 | 1,550 | |
| other | Urinary tract infection | Infections and infestations | Placebo Q2W | 54 | 788 | |
| other | Urinary tract infection | Infections and infestations | Alirocumab 150 mg Q2W | 87 | 1,550 | |
| other | Influenza | Infections and infestations | Placebo Q2W | 43 | 788 | |
| other | Influenza | Infections and infestations | Alirocumab 150 mg Q2W | 88 | 1,550 | |
| other | Bronchitis | Infections and infestations | Placebo Q2W | 40 | 788 | |
| other | Bronchitis | Infections and infestations | Alirocumab 150 mg Q2W | 83 | 1,550 |
1 to 10 of 688Source ClinicalTrials.gov
See all 688 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo Q2W | ||
| Total, all-cause mortality | Alirocumab 150 mg Q2W | ||
| Total, other adverse events | Placebo Q2W | 366 | 788 |
| Total, other adverse events | Alirocumab 150 mg Q2W | 707 | 1,550 |
| Total, serious adverse events | Placebo Q2W | 154 | 788 |
| Total, serious adverse events | Alirocumab 150 mg Q2W | 290 | 1,550 |
Source ClinicalTrials.gov
Papers6
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Alirocumab 150 mg Q2W vs Placebo Q2W: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01507831
GET https://conductscience.org/api/trials/v1/NCT01507831/registered?page=2