Ascending Multi-dose Study of REGN727(SAR236553) With and Without Concomitant Atorvastatin
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
1 other identifier
interventional
72
1 country
2
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2010
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 9, 2010
CompletedFirst Posted
Study publicly available on registry
July 13, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedJanuary 27, 2015
November 1, 2011
11 months
July 9, 2010
January 24, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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.
visit 4 (day 1) to visit 16 (day 148)
Secondary Outcomes (3)
To assess the pharmacodynamic effect of REGN727 added to atorvastatin on lipids
Visit 4 (Day 1) to Visit 16 (Day 148)
To assess the pharmacodynamic effect of monotherapy REGN727 in hyperlipidemic patients
Visit 4 (Day 1) to Visit 16 (Day 148)
To assess the pharmacokinetics of REGN727 in hyperlipidemic patients with or without atorvastatin
Visit 4 (Day 1) to Visit 16 (Day 148)
Study Arms (8)
Group 1 with atorvastatin
EXPERIMENTALDose 1 versus placebo
Group 2 with atorvastatin
EXPERIMENTALDose 1 versus placebo
Group 3 with atorvastatin
EXPERIMENTALDose 2 versus placebo
Group 4 with atorvastatin
EXPERIMENTALDose 2 versus placebo
Group 5 with atorvastatin
EXPERIMENTALDose 3 versus placebo
Group 6 with atorvastatin
EXPERIMENTALDose 3 versus placebo
Group 7 without atorvastatin
EXPERIMENTALDose 3 versus placebo
Group 8 with atorvastatin
EXPERIMENTALDose4 versus placebo
Interventions
subcutaneous
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Regeneron Pharmaceuticalslead
- Sanoficollaborator
Study Sites (2)
Site 1
Cincinnati, Ohio, United States
Site 2
Knoxville, Tennessee, United States
Related Publications (1)
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.
PMID: 22435370DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Gary Swergold, MD, PhD
Regeneron Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 9, 2010
First Posted
July 13, 2010
Study Start
June 1, 2010
Primary Completion
May 1, 2011
Study Completion
May 1, 2011
Last Updated
January 27, 2015
Record last verified: 2011-11