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

Phase 1

Completed

• Conditions: Hypercholesterolemia
• Interventions: Drug: REGN727(SAR236553)

• Registration Number: NCT01161082
• Lead Sponsor: Regeneron Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-07-09
• Study First Submitted QC: 2010-07-09
• Study First Posted: 2010-07-13
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2011-11
• Last Update Submitted: 2015-01-24
• Last Update Posted: 2015-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 8 with atorvastatin	REGN727(SAR236553)	Dose4 versus placebo
Group 6 with atorvastatin	REGN727(SAR236553)	Dose 3 versus placebo
Group 7 without atorvastatin	REGN727(SAR236553)	Dose 3 versus placebo
Group 3 with atorvastatin	REGN727(SAR236553)	Dose 2 versus placebo
Group 1 with atorvastatin	REGN727(SAR236553)	Dose 1 versus placebo
Group 2 with atorvastatin	REGN727(SAR236553)	Dose 1 versus placebo
Group 4 with atorvastatin	REGN727(SAR236553)	Dose 2 versus placebo
Group 5 with atorvastatin	REGN727(SAR236553)	Dose 3 versus placebo

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
To assess the pharmacokinetics of REGN727 in hyperlipidemic patients with or without atorvastatin	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 pharmacodynamic effect of REGN727 added to atorvastatin on lipids	Visit 4 (Day 1) to Visit 16 (Day 148)

Trial Locations

Locations (2)

Site 1; 🇺🇸 Cincinnati, Ohio, United States

Site 2; 🇺🇸 Knoxville, Tennessee, United States