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

NCT ID: NCT01161082

Last Updated: 2015-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2011-05-31

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.

Conditions

Hypercholesterolemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group 1 with atorvastatin

Dose 1 versus placebo

Group Type: EXPERIMENTAL

REGN727(SAR236553)

Intervention Type: DRUG

subcutaneous

Group 2 with atorvastatin

Dose 1 versus placebo

Group Type: EXPERIMENTAL

REGN727(SAR236553)

Intervention Type: DRUG

subcutaneous

Group 3 with atorvastatin

Dose 2 versus placebo

Group Type: EXPERIMENTAL

REGN727(SAR236553)

Intervention Type: DRUG

subcutaneous

Group 4 with atorvastatin

Dose 2 versus placebo

Group Type: EXPERIMENTAL

REGN727(SAR236553)

Intervention Type: DRUG

subcutaneous

Group 5 with atorvastatin

Dose 3 versus placebo

Group Type: EXPERIMENTAL

REGN727(SAR236553)

Intervention Type: DRUG

subcutaneous

Group 6 with atorvastatin

Dose 3 versus placebo

Group Type: EXPERIMENTAL

REGN727(SAR236553)

Intervention Type: DRUG

subcutaneous

Group 7 without atorvastatin

Dose 3 versus placebo

Group Type: EXPERIMENTAL

REGN727(SAR236553)

Intervention Type: DRUG

subcutaneous

Group 8 with atorvastatin

Dose4 versus placebo

Group Type: EXPERIMENTAL

REGN727(SAR236553)

Intervention Type: DRUG

subcutaneous

Interventions

REGN727(SAR236553)

subcutaneous

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: collaborator

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gary Swergold, MD, PhD

Role: STUDY_DIRECTOR

Regeneron Pharmaceuticals

Locations

Site 1

Cincinnati, Ohio, United States

Site 2

Knoxville, Tennessee, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 22435370 (View on PubMed)

Other Identifiers

R727-CL-1001

Identifier Type: -

Identifier Source: org_study_id