HypercholesterolemiaPhase 1NCT01161082
Ascending Multi-dose Study of REGN727(SAR236553) With and Without Concomitant Atorvastatin
A Phase 1 study testing REGN727(SAR236553) in people with Hypercholesterolemia, run by Regeneron Pharmaceuticals at 2 sites in United States.
Trial summary
This study will test the safety, tolerability, and bioeffects (how the body reacts to the drug) of REGN727 compared with placebo (an inactive substance that contains no medicine) in hyperlipidemic patients with or without atorvastatin therapy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- REGN727(SAR236553)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2010to May 2011
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women with elevated cholesterol on stable doses of atorvastatin 10-40mg/day regimen
- Body mass index between 18.0 and 35.0 kg/m2, inclusive
- For women of childbearing potential, a negative serum pregnancy test at the screening visit and a negative urine pregnancy test on day -2 or day -1
- For men and women of childbearing potential, willingness to utilize adequate contraception and not become pregnant (or have their partner[s] become pregnant)during the full duration of the study
- Willing, committed and able to return for all the clinic visits and complete all study-related procedures
- Able to read, and able to sign the informed consent form
Who cannot join
- History of MI, ACS, Angina, Stroke, peripheral vascular disease, or cardiac revascularization
- Pregnant or breast-feeding women
- Blood donation of any volume within 1 month prior to administration of study drug
- Congestive heart failure
- Consumption of greater than 1 quart of grapefruit juice per day
- Previous exposure to any therapeutic or investigational biological agent within 30 days of screening
- History of alcohol or drug abuse within one year to the screening visit
- 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.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Ascending Single to Multi-Dose Study of Safety, Tolerability, and Bioeffect of Subcutaneously Administered REGN727 in Patients With and Without Concomitant Atorvastatin
This study will test the safety, tolerability, and bioeffects (how the body reacts to the drug) of REGN727 compared with placebo (an inactive substance that contains no medicine) in hyperlipidemic patients with or without atorvastatin therapy. The study drug and placebo will be administered by subcutaneous injection at the clinic. There will be a total of 2 or 3 study drug injections over 16 clinic visits, which will include 3 overnight stays(study duration 148 days, not including the screening period). Patients on atorvastatin will take their daily dose in the morning for the duration of the study. Patients will be monitored by the study staff for side effects and the body's response to the study drug. Vital signs(blood pressure, temperature, breathing and heart rate) will be checked, and blood and urine samples will be collected at some or all visits.
- Conditions
- Hypercholesterolemia
- Being tested
- REGN727(SAR236553)
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REGN727(SAR236553)Drug
subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| Group 1 with atorvastatin | Experimental | Dose 1 versus placebo Receives: Drug: REGN727(SAR236553) |
| Group 2 with atorvastatin | Experimental | Dose 1 versus placebo Receives: Drug: REGN727(SAR236553) |
| Group 3 with atorvastatin | Experimental | Dose 2 versus placebo Receives: Drug: REGN727(SAR236553) |
| Group 4 with atorvastatin | Experimental | Dose 2 versus placebo Receives: Drug: REGN727(SAR236553) |
| Group 5 with atorvastatin | Experimental | Dose 3 versus placebo Receives: Drug: REGN727(SAR236553) |
| Group 6 with atorvastatin | Experimental | Dose 3 versus placebo Receives: Drug: REGN727(SAR236553) |
| Group 7 without atorvastatin | Experimental | Dose 3 versus placebo Receives: Drug: REGN727(SAR236553) |
| Group 8 with atorvastatin | Experimental | Dose4 versus placebo Receives: Drug: REGN727(SAR236553) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint in the study is to assess the incidence and severity of treatment-emergent adverse events in hyperlipidemic patients treated with REGN727 or placebo receiving stable doses of atorvastatin.
Measured: visit 4 (day 1) to visit 16 (day 148)
Secondary outcomes (3)
To assess the pharmacodynamic effect of REGN727 added to atorvastatin on lipids
Measured: Visit 4 (Day 1) to Visit 16 (Day 148)
To assess the pharmacodynamic effect of monotherapy REGN727 in hyperlipidemic patients
Measured: Visit 4 (Day 1) to Visit 16 (Day 148)
To assess the pharmacokinetics of REGN727 in hyperlipidemic patients with or without atorvastatin
Measured: Visit 4 (Day 1) to Visit 16 (Day 148)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2010 (estimated)
- Study startJun 2010
- Primary completionMay 2011
- Study completionMay 2011
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 Regeneron PharmaceuticalsThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Gary Swergold, MD, PhD, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01161082
- Sponsor's protocol ID
- R727-CL-1001
- Status last verified
- Nov 2011
- First submitted
- 9 Jul 2010
- Last updated
- 27 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Stein EA, Mellis S, Yancopoulos GD, Stahl N, Logan D, Smith WB, Lisbon E, Gutierrez M, Webb C, Wu R, Du Y, Kranz T, Gasparino E, Swergold GD. Effect of a monoclonal antibody to PCSK9 on LDL cholesterol. N Engl J Med. 2012 Mar 22;366(12):1108-18. doi: 10.1056/NEJMoa1105803.
PubMed 22435370
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Ascending Single to Multi-Dose Study of Safety, Tolerability, and Bioeffect of Subcutaneously Administered REGN727 in Patients With and Without Concomitant Atorvastatin
- ClinicalTrials.gov ID
- NCT01161082
- Acronym / sponsor ID
- R727-CL-1001
- Conditions
- Hypercholesterolemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Study start
- Jun 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 13 Jul 2010 (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.
This study will test the safety, tolerability, and bioeffects (how the body reacts to the drug) of REGN727 compared with placebo (an inactive substance that contains no medicine) in hyperlipidemic patients with or without atorvastatin therapy. The study drug and placebo will be administered by subcutaneous injection at the clinic. There will be a total of 2 or 3 study drug injections over 16 clinic visits, which will include 3 overnight stays(study duration 148 days, not including the screening period). Patients on atorvastatin will take their daily dose in the morning for the duration of the study. Patients will be monitored by the study staff for side effects and the body's response to the study drug. Vital signs(blood pressure, temperature, breathing and heart rate) will be checked, and blood and urine samples will be collected at some or all visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Group 1 with atorvastatin | Experimental | Drug: REGN727(SAR236553)Dose 1 versus placebo |
| Group 2 with atorvastatin | Experimental | Drug: REGN727(SAR236553)Dose 1 versus placebo |
| Group 3 with atorvastatin | Experimental | Drug: REGN727(SAR236553)Dose 2 versus placebo |
| Group 4 with atorvastatin | Experimental | Drug: REGN727(SAR236553)Dose 2 versus placebo |
| Group 5 with atorvastatin | Experimental | Drug: REGN727(SAR236553)Dose 3 versus placebo |
| Group 6 with atorvastatin | Experimental | Drug: REGN727(SAR236553)Dose 3 versus placebo |
| Group 7 without atorvastatin | Experimental | Drug: REGN727(SAR236553)Dose 3 versus placebo |
| Group 8 with atorvastatin | Experimental | Drug: REGN727(SAR236553)Dose4 versus placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men and women with elevated cholesterol on stable doses of atorvastatin 10-40mg/day regimen
- Body mass index between 18.0 and 35.0 kg/m2, inclusive
- For women of childbearing potential, a negative serum pregnancy test at the screening visit and a negative urine pregnancy test on day -2 or day -1
- For men and women of childbearing potential, willingness to utilize adequate contraception and not become pregnant (or have their partner[s] become pregnant)during the full duration of the study
- Willing, committed and able to return for all the clinic visits and complete all study-related procedures
Key exclusion criteria (8 listed)
- History of MI, ACS, Angina, Stroke, peripheral vascular disease, or cardiac revascularization
- Pregnant or breast-feeding women
- Blood donation of any volume within 1 month prior to administration of study drug
- Congestive heart failure
- Consumption of greater than 1 quart of grapefruit juice per day
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 |
|---|---|---|
| REGN727(SAR236553)subcutaneous | Drug | Group 1 with atorvastatin, Group 2 with atorvastatin, Group 3 with atorvastatin, Group 4 with atorvastatin, Group 5 with atorvastatin, Group 6 with atorvastatin, Group 7 without atorvastatin, Group 8 with atorvastatin |
Primary outcome
The primary endpoint in the study is to assess the incidence and severity of treatment-emergent adverse events in hyperlipidemic patients treated with REGN727 or placebo receiving stable doses of atorvastatin.
Time frame: visit 4 (day 1) to visit 16 (day 148)
3 secondary outcomes
To assess the pharmacodynamic effect of REGN727 added to atorvastatin on lipids
Time frame: Visit 4 (Day 1) to Visit 16 (Day 148)
To assess the pharmacodynamic effect of monotherapy REGN727 in hyperlipidemic patients
Time frame: Visit 4 (Day 1) to Visit 16 (Day 148)
To assess the pharmacokinetics of REGN727 in hyperlipidemic patients with or without atorvastatin
Time frame: Visit 4 (Day 1) to Visit 16 (Day 148)
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 27 Jan 2015.
- Derived from this study: PubMed 22435370Stein EA, Mellis S, Yancopoulos GD, Stahl N, Logan D, Smith WB, Lisbon E, Gutierrez M, Webb C, Wu R, Du Y, Kranz T, Gasparino E, Swergold GD. Effect of a monoclonal antibody to PCSK9 on LDL cholesterol. N Engl J Med. 2012 Mar 22;366(12):1108-18. doi: 10.1056/NEJMoa1105803.
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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.
Gary Swergold, MD, PhD study director
Regeneron Pharmaceuticals
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 REGN727(SAR236553) in people with Hypercholesterolemia, run by Regeneron Pharmaceuticals at 2 sites in United States.
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 6 inclusion and 8 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 27 Jan 2015. 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 United States. 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?
The primary endpoint in the study is to assess the incidence and severity of treatment-emergent adverse events in hyperlipidemic patients treated with REGN727 or placebo receiving stable doses of atorvastatin. (time frame: visit 4 (day 1) to visit 16 (day 148)). 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 NCT01161082, 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 27 Jan 2015.