Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe in Patients With Hypercholesterolemia (ODYSSEY MONO)

Sanofi

Status and phase: Completed; Phase 3

Conditions: Hypercholesterolemia

Treatments: Drug: Placebo (for Alirocumab); Drug: Placebo (for Ezetimibe); Drug: Alirocumab; Drug: Ezetimibe

Study type: Interventional

Funder types: Industry

Identifiers

NCT01644474

U1111-1124-1167 (Other Identifier)

2011-001424-38 (EudraCT Number)

EFC11716

Details and patient eligibility

About

Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9).

Primary Objective of the study:

To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab in comparison with ezetimibe after 24 weeks of treatment in participants with hypercholesterolemia.

Secondary Objectives:

• To evaluate the effect of alirocumab in comparison with ezetimibe on LDL-C at other time points
• To evaluate the effect of alirocumab on other lipid parameters
• To evaluate the safety and tolerability of alirocumab

Full description

The maximum study duration was 34 weeks per participant, including a 24-week randomized treatment period.

Enrollment: 103 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants with hypercholesterolemia

Exclusion criteria

• Age < 18 or legal age of adulthood, whichever was greater
• LDL-C < 100 mg/dL (< 2.59 mmol/L) or > 190 mg/dL (> 4.9 mmol/L)
• Fasting serum triglycerides (TG) > 400 mg/dL (> 4.52 mmol/L)
• Known history of homozygous or heterozygous familial hypercholesterolemia

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

103 participants in 2 patient groups

Ezetimibe 10 mg

Active Comparator group

Description:

Oral ezetimibe 10 mg capsule daily and subcutaneous (SC) placebo injection for alirocumab every 2 weeks (Q2W) for 24 weeks.

Treatment:

Drug: Placebo (for Alirocumab)

Drug: Ezetimibe

Alirocumab 75/Up to 150 mg Q2W

Experimental group

Description:

SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.

Treatment:

Drug: Placebo (for Ezetimibe)

Drug: Alirocumab