Trial · NCT01730040
Study of the Efficacy and Safety of Alirocumab (REGN727/SAR236553) in Combination With Other Lipid-modifying Treatment (LMT) (ODYSSEY OPTIONS I)
NCT01730040, Phase 3, Completed, Regeneron Pharmaceuticals; results first posted 2015-08-31
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of the Efficacy and Safety of Alirocumab (REGN727/SAR236553) in Combination With Other Lipid-modifying Treatment (LMT) (ODYSSEY OPTIONS I). Trials, record NCT01730040. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01730040
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of the Efficacy and Safety of Alirocumab (REGN727/SAR236553) in Combination With Other Lipid-modifying Treatment (LMT) (ODYSSEY OPTIONS I)
- NCT number
- NCT01730040
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 355 participants, actual
- Lead sponsor
- Regeneron Pharmaceuticals
- Conditions
- Hypercholesterolemia
- Interventions
- Alirocumab, Atorvastatin, Ezetimibe, Rosuvastatin, Placebo
- First posted
- 2012-11-21
- Last updated
- 2015-08-31
- Results first posted
- 2015-08-31
Source ClinicalTrials.gov
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-treat (ITT) Analysis | From Baseline to Week 24 | Calculated LDL-C values were obtained from Friedewald formula. 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 24 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 24 | Calculated LDL-C values were obtained from Friedewald formula. 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 24 (i.e. up to 21 days after last injection or 3 days after the last capsule \[whatever atorvastatin, rosuvastatin or ezetimibe\], whichever came first) (on-treatment analysis). |
| Secondary | Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis | From Baseline to Week 24 | Calculated LDL-C values were obtained from Friedewald formula. Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment (ITT analysis). |
| Secondary | Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis | From Baseline to Week 24 | Calculated LDL-C values were obtained from Friedewald formula. Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule \[whatever atorvastatin, rosuvastatin or ezetimibe\], whichever came first) (on-treatment analysis). |
| Secondary | Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis | From Baseline to Week 24 | Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 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 24 | 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 24 (ie. up to 21 days after last injection or 3 days after the last capsule \[whatever atorvastatin, rosuvastatin or ezetimibe\], whichever came first). |
| Secondary | Percent Change From Baseline in Non-High-density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis | From Baseline to Week 24 | Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 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 24 | 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 24 (i.e. up to 21 days after last injection or 3 days after the last capsule \[whatever atorvastatin, rosuvastatin or ezetimibe\], whichever came first). |
| Secondary | Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis | From Baseline to Week 24 | Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. |
| Secondary | Percent Change From Baseline in Apo B at Week 12 - ITT Analysis | From Baseline to Week 24 | Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 registered outcomesOutcomes24
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-treat (ITT) Analysis | From Baseline to Week 24 | 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 24 | 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 24 | 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 24 | mITT population. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis | From Baseline to Week 24 | Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline Apo B value on- or off-treatment. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis | From Baseline to Week 24 | Participants analyzed: participants of the mITT population with one baseline and at least one post-baseline Apo B value on-treatment. | 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 24 | Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline non-HDL-C value on- or off-treatment. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Non-HDL-C at Week 24 - On-Treatment Analysis | From Baseline to Week 24 | Participants analyzed: participants of the mITT population with one baseline and at least one post-baseline Non-HDL-C value on-treatment. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis | From Baseline to Week 24 | Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline Total-C value on- or off-treatment. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Apo B at Week 12 - ITT Analysis | From Baseline to Week 24 | Apo B ITT population. | percent change | LEAST_SQUARES_MEAN |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 outcomesResults by group168
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-treat (ITT) Analysis | Atorvastatin 40 mg | -5 | Standard Error 4.6 | percent change | |
| Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-treat (ITT) Analysis | Ezetimibe 10 mg + Atorvastatin 20 mg | -20.5 | Standard Error 4.7 | percent change | |
| Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-treat (ITT) Analysis | Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg | -44.1 | Standard Error 4.5 | percent change | |
| Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-treat (ITT) Analysis | Atorvastatin 80 mg | -4.8 | Standard Error 4.2 | percent change | |
| Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-treat (ITT) Analysis | Rosuvastatin 40 mg | -21.4 | Standard Error 4.2 | percent change | |
| Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-treat (ITT) Analysis | Ezetimibe 10 mg + Atorvastatin 40 mg | -22.6 | Standard Error 4.3 | percent change | |
| Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-treat (ITT) Analysis | Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg | -54 | Standard Error 4.3 | percent change | |
| Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis | Atorvastatin 40 mg | -6.1 | Standard Error 4.6 | percent change | |
| Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis | Ezetimibe 10 mg + Atorvastatin 20 mg | -23.7 | Standard Error 4.7 | percent change | |
| Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis | Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg | -48.6 | Standard Error 4.5 | percent change |
1 to 10 of 168Source ClinicalTrials.gov
See all 168 results by groupParticipant flow28
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Atorvastatin 40 mg | 57 | |
| Overall Study | STARTED | Ezetimibe 10 mg + Atorvastatin 20 mg | 55 | |
| Overall Study | STARTED | Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg | 57 | |
| Overall Study | STARTED | Atorvastatin 80 mg | 47 | |
| Overall Study | STARTED | Rosuvastatin 40 mg | 45 | |
| Overall Study | STARTED | Ezetimibe 10 mg + Atorvastatin 40 mg | 47 | |
| Overall Study | STARTED | Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg | 47 | |
| Overall Study | Treated | Atorvastatin 40 mg | 57 | |
| Overall Study | Treated | Ezetimibe 10 mg + Atorvastatin 20 mg | 55 | |
| Overall Study | Treated | Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg | 57 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 participant flowAdverse events238
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 | Diarrhoea | Gastrointestinal disorders | Atorvastatin 40 mg | 4 | 57 | 4 |
| other | Diarrhoea | Gastrointestinal disorders | Ezetimibe 10 mg + Atorvastatin 20 mg | 1 | 55 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg | 1 | 57 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | Atorvastatin 80 mg | 1 | 47 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | Rosuvastatin 40 mg | 3 | 45 | 6 |
| other | Diarrhoea | Gastrointestinal disorders | Ezetimibe 10 mg + Atorvastatin 40 mg | 2 | 46 | 3 |
| other | Diarrhoea | Gastrointestinal disorders | Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg | 1 | 47 | 1 |
| other | Nausea | Gastrointestinal disorders | Atorvastatin 40 mg | 3 | 57 | 3 |
| other | Nausea | Gastrointestinal disorders | Ezetimibe 10 mg + Atorvastatin 20 mg | 3 | 55 | 3 |
| other | Nausea | Gastrointestinal disorders | Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg | 1 | 57 | 1 |
1 to 10 of 238Source ClinicalTrials.gov
See all 238 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Atorvastatin 40 mg | ||
| Total, all-cause mortality | Ezetimibe 10 mg + Atorvastatin 20 mg | ||
| Total, all-cause mortality | Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg | ||
| Total, all-cause mortality | Atorvastatin 80 mg | ||
| Total, all-cause mortality | Rosuvastatin 40 mg | ||
| Total, all-cause mortality | Ezetimibe 10 mg + Atorvastatin 40 mg | ||
| Total, all-cause mortality | Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg | ||
| Total, other adverse events | Atorvastatin 40 mg | 17 | 57 |
| Total, other adverse events | Ezetimibe 10 mg + Atorvastatin 20 mg | 24 | 55 |
| Total, other adverse events | Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg | 15 | 57 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers5
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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GET https://conductscience.org/api/trials/v1/NCT01730040
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