search
Back to results

Ascending Multi-dose Study of REGN727(SAR236553) With and Without Concomitant Atorvastatin

Primary Purpose

Hypercholesterolemia

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
REGN727(SAR236553)
Sponsored by
Regeneron Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

  • 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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Site 1
  • Site 2

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

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

Arm Description

Dose 1 versus placebo

Dose 1 versus placebo

Dose 2 versus placebo

Dose 2 versus placebo

Dose 3 versus placebo

Dose 3 versus placebo

Dose 3 versus placebo

Dose4 versus placebo

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

To assess the pharmacodynamic effect of REGN727 added to atorvastatin on lipids
To assess the pharmacodynamic effect of monotherapy REGN727 in hyperlipidemic patients
To assess the pharmacokinetics of REGN727 in hyperlipidemic patients with or without atorvastatin

Full Information

First Posted
July 9, 2010
Last Updated
January 24, 2015
Sponsor
Regeneron Pharmaceuticals
Collaborators
Sanofi
search

1. Study Identification

Unique Protocol Identification Number
NCT01161082
Brief Title
Ascending Multi-dose Study of REGN727(SAR236553) With and Without Concomitant Atorvastatin
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Regeneron Pharmaceuticals
Collaborators
Sanofi

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 with atorvastatin
Arm Type
Experimental
Arm Description
Dose 1 versus placebo
Arm Title
Group 2 with atorvastatin
Arm Type
Experimental
Arm Description
Dose 1 versus placebo
Arm Title
Group 3 with atorvastatin
Arm Type
Experimental
Arm Description
Dose 2 versus placebo
Arm Title
Group 4 with atorvastatin
Arm Type
Experimental
Arm Description
Dose 2 versus placebo
Arm Title
Group 5 with atorvastatin
Arm Type
Experimental
Arm Description
Dose 3 versus placebo
Arm Title
Group 6 with atorvastatin
Arm Type
Experimental
Arm Description
Dose 3 versus placebo
Arm Title
Group 7 without atorvastatin
Arm Type
Experimental
Arm Description
Dose 3 versus placebo
Arm Title
Group 8 with atorvastatin
Arm Type
Experimental
Arm Description
Dose4 versus placebo
Intervention Type
Drug
Intervention Name(s)
REGN727(SAR236553)
Intervention Description
subcutaneous
Primary Outcome Measure Information:
Title
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)
Secondary Outcome Measure Information:
Title
To assess the pharmacodynamic effect of REGN727 added to atorvastatin on lipids
Time Frame
Visit 4 (Day 1) to Visit 16 (Day 148)
Title
To assess the pharmacodynamic effect of monotherapy REGN727 in hyperlipidemic patients
Time Frame
Visit 4 (Day 1) to Visit 16 (Day 148)
Title
To assess the pharmacokinetics of REGN727 in hyperlipidemic patients with or without atorvastatin
Time Frame
Visit 4 (Day 1) to Visit 16 (Day 148)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary Swergold, MD, PhD
Organizational Affiliation
Regeneron Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Site 1
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Site 2
City
Knoxville
State/Province
Tennessee
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22435370
Citation
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.
Results Reference
derived

Learn more about this trial

Ascending Multi-dose Study of REGN727(SAR236553) With and Without Concomitant Atorvastatin

We'll reach out to this number within 24 hrs