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

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01161082
First received: July 9, 2010
Last updated: November 7, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention Phase
Hypercholesterolemia
Biological: REGN727(SAR236553)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Regeneron Pharmaceuticals:

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. [ Time Frame: visit 4 (day 1) to visit 16 (day 148) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the pharmacodynamic effect of REGN727 added to atorvastatin on lipids [ Time Frame: Visit 4 (Day 1) to Visit 16 (Day 148) ] [ Designated as safety issue: No ]
  • To assess the pharmacodynamic effect of monotherapy REGN727 in hyperlipidemic patients [ Time Frame: Visit 4 (Day 1) to Visit 16 (Day 148) ] [ Designated as safety issue: No ]
  • To assess the pharmacokinetics of REGN727 in hyperlipidemic patients with or without atorvastatin [ Time Frame: Visit 4 (Day 1) to Visit 16 (Day 148) ] [ Designated as safety issue: No ]

Enrollment: 72
Study Start Date: June 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1 with atorvastatin
Dose 1 versus placebo
Biological: REGN727(SAR236553)
subcutaneous
Experimental: Group 2 with atorvastatin
Dose 1 versus placebo
Biological: REGN727(SAR236553)
subcutaneous
Experimental: Group 3 with atorvastatin
Dose 2 versus placebo
Biological: REGN727(SAR236553)
subcutaneous
Experimental: Group 4 with atorvastatin
Dose 2 versus placebo
Biological: REGN727(SAR236553)
subcutaneous
Experimental: Group 5 with atorvastatin
Dose 3 versus placebo
Biological: REGN727(SAR236553)
subcutaneous
Experimental: Group 6 with atorvastatin
Dose 3 versus placebo
Biological: REGN727(SAR236553)
subcutaneous
Experimental: Group 7 without atorvastatin
Dose 3 versus placebo
Biological: REGN727(SAR236553)
subcutaneous
Experimental: Group 8 with atorvastatin
Dose4 versus placebo
Biological: REGN727(SAR236553)
subcutaneous

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01161082

Locations
United States, Ohio
Site 1
Cincinnati, Ohio, United States
United States, Tennessee
Site 2
Knoxville, Tennessee, United States
Sponsors and Collaborators
Regeneron Pharmaceuticals
Sanofi
Investigators
Study Director: Gary Swergold, MD, PhD Regeneron Pharmaceuticals
  More Information

No publications provided by Regeneron Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01161082     History of Changes
Other Study ID Numbers: R727-CL-1001
Study First Received: July 9, 2010
Last Updated: November 7, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 01, 2014