Long-term Safety and Tolerability of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY Long Term)

Sanofi

Status and phase: Completed; Phase 3

Conditions: Hypercholesterolemia

Treatments: Drug: Placebo (for alirocumab); Drug: Lipid-Modifying Therapy (LMT); Drug: Alirocumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01507831

U1111-1121-3928 (Other Identifier)

LTS11717

2011-002806-59 (EudraCT Number)

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 evaluate the long-term safety and tolerability of alirocumab in high cardiovascular risk participants with hypercholesterolemia not adequately controlled with their current lipid modifying therapy (LMT).

Secondary Objectives:

• To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 24 weeks of treatment in comparison with placebo.
• To evaluate the effect of alirocumab in comparison with placebo on LDL-C at other time points.
• To evaluate the effects of alirocumab on other lipid parameters.

Full description

The maximum study duration was to be 89 weeks per participant, including a 3-week screening period, a 78-week randomized treatment period and 8-week follow-up period.

Enrollment: 2,341 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Either A or B below and who were not adequately controlled with their lipid-modifying therapy:

A) Participants with heterozygous familial hypercholesterolemia (heFH) with or without established coronary heart disease (CHD) or CHD risk equivalents

OR

B) Participants with hypercholesterolemia together with established CHD or CHD risk equivalents.

Exclusion criteria

• Age < 18 years
• LDL-C <70 mg/dL (< 1.81 mmol/L)
• Fasting serum triglycerides > 400 mg/dL (>4.52 mmol/L)

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

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2,341 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo (for alirocumab) every 2 weeks (Q2W) added to stable Lipid-Modifying Therapy (LMT) for 78 weeks.

Treatment:

Drug: Lipid-Modifying Therapy (LMT)

Drug: Placebo (for alirocumab)

Alirocumab

Experimental group

Description:

Alirocumab 150 mg Q2W added to stable LMT for 78 weeks.

Treatment:

Drug: Lipid-Modifying Therapy (LMT)

Drug: Alirocumab