Phase III Study To Evaluate Alirocumab in Patients With Hypercholesterolemia Not Treated With a Statin (ODYSSEY CHOICE II)

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy and Safety of Alirocumab in Patients with Primary Hypercholesterolemia Not Treated With a Statin - ODYSSEY CHOICE II

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-002659-14-BE

Enrollment

200

Registered

2013-09-05

Start date

2013-12-23

Completion date

Unknown

Last updated

2018-04-30

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

Conditions

Hypercholesterolaemia MedDRA version: 18.1 Level: PT Classification code 10020603 Term: Hypercholesterolaemia System Organ Class: 10027433 - Metabolism and nutrition disorders

Interventions

Trade Name: Praluent Product Name: alirocumab Product Code: SAR236553 (REGN727) Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: alirocumab CAS Number: 1245916-14

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with primary hypercholesterolemia (heFH or non-FH) not adequately controlled with their non statin lipid modifying therapy or diet. 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 150 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50

Exclusion criteria

Exclusion criteria: LDL-C 160 mg/dL (>4.1 mmol/L) if receiving diet only or a non-statin LMT for patients not fulfulling the statin intolerant defintion

Design outcomes

Primary

Measure	Time frame
Main Objective: To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as addon to non-statin lipid modifying background therapy or as monotherapy in comparison with placebo in patients with primary hypercholesterolemia not treated with a statin;Secondary Objective: To evaluate the safety and tolerability of alirocumab;Primary end point(s): The percent change in LDL-C from baseline to Week 24.;Timepoint(s) of evaluation of this end point: At 24 weeks	—

Measure

Time frame

Main Objective: To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as addon to non-statin lipid modifying background therapy or as monotherapy in comparison with placebo in patients with primary hypercholesterolemia not treated with a statin;Secondary Objective: To evaluate the safety and tolerability of alirocumab;Primary end point(s): The percent change in LDL-C from baseline to Week 24.;Timepoint(s) of evaluation of this end point: At 24 weeks

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Secondary

Measure	Time frame
Secondary end point(s): Safety parameters (adverse events, cardiovascular events, laboratory data, vital signs, and ECG) assessed throughout the study The percent change in Apolipoprotein B (ApoB) The percent change in non-high density lipoprotein cholesterol (non-HDL-C) The percent change in Total-Cholesterol (TC) The percent change in Lipoprotein (a) (Lp(a)) The percent change in high-density lipoprotein cholesterol (HDL-C) The percent change in Triglyceride (TG) The percent change in Apoliprotein A-1 (Apo A-1) levels ;Timepoint(s) of evaluation of this end point: From baseline up to week 24	—

Measure

Time frame

Secondary end point(s): Safety parameters (adverse events, cardiovascular events, laboratory data, vital signs, and ECG) assessed throughout the study The percent change in Apolipoprotein B (ApoB) The percent change in non-high density lipoprotein cholesterol (non-HDL-C) The percent change in Total-Cholesterol (TC) The percent change in Lipoprotein (a) (Lp(a)) The percent change in high-density lipoprotein cholesterol (HDL-C) The percent change in Triglyceride (TG) The percent change in Apoliprotein A-1 (Apo A-1) levels ;Timepoint(s) of evaluation of this end point: From baseline up to week 24

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Countries

Australia, Belgium, Canada, Denmark, Netherlands, New Zealand, Spain, United States

Contacts

Public ContactBrigitte De Witte

Sanofi Belgium

Contact-us@sanofi.com+32(0)2 710 54 00

Outcome results

None listed

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