HypercholesterolemiaPhase 1NCT01723735
Effect of Alirocumab (SAR236553/REGN727) Administered on Top of Ezetimibe or Fenofibrate on Lipid Profiles in Healthy Subjects
A Phase 1 study testing Alirocumab, Ezetimibe and Fenofibrate in people with Hypercholesterolemia, run by Sanofi at 2 sites in France.
Trial summary
Primary Objective: To assess the pharmacodynamic profile of alirocumab (SAR236553/REGN727) administered either alone or on top of ezetimibe or fenofibrate, based on low-density lipoprotein -cholesterol (LDL-C). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Alirocumab, Ezetimibe and Fenofibrate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 2 sitesFrance
- Study dates
- Nov 2012to Jul 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male /or female subjects,
- aged 18 to 65 years old,
- with LDL-C > 130 mg/dL
- not receiving lipid lowering therapy.
Who cannot join
- Healthy subjects with history or presence of clinically relevant illness.
- Subjects currently taking statins, ezetimibe or fenofibrate.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Investigational Site Number 250001
Rennes, 35000
Investigational Site Number 250002
Rueil-Malmaison, 92502
About this study
Official title: A Randomized, Partial Blind, 3 Parallel Groups Study of the Pharmacodynamic Profile of SAR236553 (REGN727) Administered as Multiple Subcutaneous Doses, Either Alone or on Top of Ezetimibe or Fenofibrate Administered as Multiple Oral Doses in Healthy Subjects
Primary Objective:
To assess the pharmacodynamic profile of alirocumab (SAR236553/REGN727) administered either alone or on top of ezetimibe or fenofibrate, based on low-density lipoprotein -cholesterol (LDL-C).
Secondary Objectives:
- To assess the pharmacodynamic profile of alirocumab administered either alone or on top of ezetimibe or fenofibrate, based on other lipid parameters.
- To assess the pharmacokinetic profile of alirocumab administered either alone or on top of ezetimibe or fenofibrate.
Read the detailed description
Total duration of the study per subject (excluding screening) is about 22 weeks.
- Conditions
- Hypercholesterolemia
- Being tested
- Alirocumab, Ezetimibe, Ezetimibe Placebo, Fenofibrate
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlirocumabDrug
Also called SAR236553, REGN727
Pharmaceutical form: solution for injection
Route of administration: subcutaneous
EzetimibeDrug
Pharmaceutical form: overencapsulated tablet
Route of administration: oral
Ezetimibe PlaceboDrug
Pharmaceutical form: capsule
Route of administration: oral
FenofibrateDrug
Pharmaceutical form: tablet
Route of administration: oral
| Study group | Role | What they receive |
|---|---|---|
| Alirocumab + Ezetimibe Placebo | Experimental | Subcutaneous (SC) injections of alirocumab added to oral administration of ezetimibe placebo Receives: Drug: Alirocumab; Drug: Ezetimibe Placebo |
| Alirocumab + Ezetimibe | Experimental | Subcutaneous (SC) injections of alirocumab added to oral administration of ezetimibe Receives: Drug: Alirocumab; Drug: Ezetimibe |
| Alirocumab + Fenofibrate | Experimental | Subcutaneous (SC) injections of alirocumab added to oral administration of fenofibrate Receives: Drug: Alirocumab; Drug: Fenofibrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the effect of alirocumab on LDL-C
Measured: Up to 18 weeks
Secondary outcomes (3)
Assessment of the pharmacodynamic profile of alirocumab
Measured: Up to 18 weeks
Pharmacokinetics: Assessment of serum concentrations of alirocumab
Measured: Up to 18 weeks
Pharmacokinetics: Assessment of serum concentrations of proprotein convertase subtilisin kexin type 9 (PCSK9)
Measured: Up to 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01723735
- Sponsor's protocol ID
- PKD12910
- Other IDs
- U1111-1131-3203, 2012-003049-13
- Status last verified
- Sep 2016
- First submitted
- 6 Nov 2012
- Last updated
- 28 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Rey J, Poitiers F, Paehler T, Brunet A, DiCioccio AT, Cannon CP, Surks HK, Pinquier JL, Hanotin C, Sasiela WJ. Relationship Between Low-Density Lipoprotein Cholesterol, Free Proprotein Convertase Subtilisin/Kexin Type 9, and Alirocumab Levels After Different Lipid-Lowering Strategies. J Am Heart Assoc. 2016 Jun 10;5(6):e003323. doi: 10.1161/JAHA.116.003323.
PubMed 27287699
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Partial Blind, 3 Parallel Groups Study of the Pharmacodynamic Profile of SAR236553 (REGN727) Administered as Multiple Subcutaneous Doses, Either Alone or on Top of Ezetimibe or Fenofibrate Administered as Multiple Oral Doses in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01723735
- Acronym / sponsor ID
- PKD12910
- Conditions
- Hypercholesterolemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- Nov 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 8 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objective:
To assess the pharmacodynamic profile of alirocumab (SAR236553/REGN727) administered either alone or on top of ezetimibe or fenofibrate, based on low-density lipoprotein -cholesterol (LDL-C).
Secondary Objectives:
- To assess the pharmacodynamic profile of alirocumab administered either alone or on top of ezetimibe or fenofibrate, based on other lipid parameters.
- To assess the pharmacokinetic profile of alirocumab administered either alone or on top of ezetimibe or fenofibrate.
Detailed description
Total duration of the study per subject (excluding screening) is about 22 weeks.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Alirocumab + Ezetimibe Placebo | Experimental | Drug: Alirocumab, Drug: Ezetimibe PlaceboSubcutaneous (SC) injections of alirocumab added to oral administration of ezetimibe placebo |
| Alirocumab + Ezetimibe | Experimental | Drug: Alirocumab, Drug: EzetimibeSubcutaneous (SC) injections of alirocumab added to oral administration of ezetimibe |
| Alirocumab + Fenofibrate | Experimental | Drug: Alirocumab, Drug: FenofibrateSubcutaneous (SC) injections of alirocumab added to oral administration of fenofibrate |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy male /or female subjects,
- aged 18 to 65 years old,
- with LDL-C > 130 mg/dL
- not receiving lipid lowering therapy.
Key exclusion criteria (3 listed)
- Healthy subjects with history or presence of clinically relevant illness.
- Subjects currently taking statins, ezetimibe or fenofibrate.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlirocumabAlso: SAR236553, REGN727Pharmaceutical form: solution for injection Route of administration: subcutaneous | Drug | Alirocumab + Ezetimibe, Alirocumab + Ezetimibe Placebo, Alirocumab + Fenofibrate |
| EzetimibePharmaceutical form: overencapsulated tablet Route of administration: oral | Drug | Alirocumab + Ezetimibe |
| Ezetimibe PlaceboPharmaceutical form: capsule Route of administration: oral | Drug | Alirocumab + Ezetimibe Placebo |
| FenofibratePharmaceutical form: tablet Route of administration: oral | Drug | Alirocumab + Fenofibrate |
Primary outcome
Assessment of the effect of alirocumab on LDL-C
Time frame: Up to 18 weeks
3 secondary outcomes
Assessment of the pharmacodynamic profile of alirocumab
Time frame: Up to 18 weeks
Pharmacokinetics: Assessment of serum concentrations of alirocumab
Time frame: Up to 18 weeks
Pharmacokinetics: Assessment of serum concentrations of proprotein convertase subtilisin kexin type 9 (PCSK9)
Time frame: Up to 18 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2016.
- Results publication: PubMed 27287699Rey J, Poitiers F, Paehler T, Brunet A, DiCioccio AT, Cannon CP, Surks HK, Pinquier JL, Hanotin C, Sasiela WJ. Relationship Between Low-Density Lipoprotein Cholesterol, Free Proprotein Convertase Subtilisin/Kexin Type 9, and Alirocumab Levels After Different Lipid-Lowering Strategies. J Am Heart Assoc. 2016 Jun 10;5(6):e003323. doi: 10.1161/JAHA.116.003323.
Related trials for Hypercholesterolemia
Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Alirocumab, Ezetimibe and Fenofibrate in people with Hypercholesterolemia, run by Sanofi at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the effect of alirocumab on LDL-C (time frame: Up to 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01723735, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2016.