Efficacy and Safety of SAR236553 (REGN727) Versus Ezetimibe in Patients with Hypercholesterolemia

A Randomized, Double-Blind, Active-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of SAR236553/REGN727 over 24 weeks in Patients with Hypercholesterolemia

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-001424-38-BE

Enrollment

182

Registered

2012-06-26

Start date

2012-08-03

Completion date

Unknown

Last updated

2017-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesterolaemia MedDRA version: 16.1 Level: PT Classification code 10020603 Term: Hypercholesterolaemia System Organ Class: 10027433 - Metabolism and nutrition disorders

Interventions

Product Code: SAR236553 (REGN727) Pharmaceutical Form: Solution for injection CAS Number: 1245916-14-6 Current Sponsor code: SAR236553 (REGN727) Concentration unit: mg/ml milligram(s)/millilitre Conce

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with hypercholesterolemia Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 162 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: Age 190 mg/dL (> 4.9 mmol/L) Fasting serum TG > 400 mg/dL (> 4.52 mmol/L) Known history of homozygous or heterozygous familial hypercholesterolemia

Design outcomes

Primary

Measure	Time frame
Main Objective: To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by SAR236553 (REGN727) in comparison with ezetimibe (EZE) after 24 weeks of treatment in patients with hypercholesterolemia;Secondary Objective: -To evaluate the effect of SAR236553 (REGN727) in comparison with EZE on LDL-C at other time points - To evaluate the effect of SAR236553 (REGN727) on other lipid parameters - To evaluate the safety and tolerability of SAR236553 (REGN727) ;Primary end point(s): Percent change in LDL-C;Timepoint(s) of evaluation of this end point: From baseline to week 24	—

Measure

Time frame

Main Objective: To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by SAR236553 (REGN727) in comparison with ezetimibe (EZE) after 24 weeks of treatment in patients with hypercholesterolemia;Secondary Objective: -To evaluate the effect of SAR236553 (REGN727) in comparison with EZE on LDL-C at other time points - To evaluate the effect of SAR236553 (REGN727) on other lipid parameters - To evaluate the safety and tolerability of SAR236553 (REGN727) ;Primary end point(s): Percent change in LDL-C;Timepoint(s) of evaluation of this end point: From baseline to week 24

—

Secondary

Measure	Time frame
Secondary end point(s): Percent change in LDL-C Percent change in other lipid parameters ;Timepoint(s) of evaluation of this end point: From baseline up to week 12 for Percent change in LDL-C From baseline up to week 24 for Percent change in other lipid parameters	—

Countries

Belgium, Finland, Netherlands, United States

Contacts

Public ContactBrigitte De Witte

Sanofi Belgium

contact-us@sanofi.com+322710 54 00

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026