Phase 3 Completed N=720 Randomized Quadruple-blind Treatment

Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe on Top of Statin in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY COMBO II)

Hypercholesterolemia

Source: ClinicalTrials.gov NCT01644188 ↗

Enrolled (actual)

720

Serious AEs

25.6%

Results posted

Nov 2015

Primary outcomePrimary: Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-treat (ITT) Analysis — -50.6; -20.7 percent change — p=<0.0001

Summary

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 as add-on therapy to stable maximally tolerated daily statin therapy in comparison with ezetimibe after 24 weeks of treatment in participants with hypercholesterolemia at high cardiovascular (CV) risk. 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

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-treat (ITT) Analysis	-50.6; -20.7	<0.0001 sig
SECONDARY Percent Change From Baseline in Calculated LDL--C at Week 24 - On--Treatment Analysis	-52.4; -21.8	<0.0001 sig
SECONDARY Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis	-51.2; -21.8	<0.0001 sig
SECONDARY Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis	-52.4; -22.7	<0.0001 sig
SECONDARY Percent Change From Baseline in Apolipoprotein B (Apo-B) at Week 24 - ITT Analysis	-40.7; -18.3	<0.0001 sig
SECONDARY Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis	-42.1; -19.1	<0.0001 sig
SECONDARY Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis	-42.1; -19.2	<0.0001 sig
SECONDARY Percent Change From Baseline in Non-HDL-C at Week 24 - On-Treatment Analysis	-43.7; -20.2	<0.0001 sig
SECONDARY Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis	-29.3; -14.6	<0.0001 sig
SECONDARY Percent Change From Baseline in Apo-B at Week 12 - ITT Analysis	-39.7; -17.2	<0.0001 sig
SECONDARY Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis	-42.6; -20.6	<0.0001 sig
SECONDARY Percent Change From Baseline in Total-C at Week 12 - ITT Analysis	-29.4; -15.1	<0.0001 sig
SECONDARY Percent Change From Baseline in Calculated LDL-C at Week 52 - ITT Analysis	-49.5; -18.3	<0.0001 sig
SECONDARY Percentage of Participants Achieving Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis	77; 45.6	<0.0001 sig
SECONDARY Percentage of Participants Achieving Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis	78.9; 47.4	<0.0001 sig
SECONDARY Percent Change From Baseline in Lipoprotein(a) at Week 24 - ITT Analysis	-27.8; -6.1	<0.0001 sig
SECONDARY Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis	8.6; 0.5	<0.0001 sig
SECONDARY Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis	-13; -12.8	0.9117
SECONDARY Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Week 24 - ITT Analysis	5; -1.3	—
SECONDARY Percent Change From Baseline in Lipoprotein(a) at Week 12 - ITT Analysis	-22.1; 1.1	—
SECONDARY Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis	8.7; 2.8	—
SECONDARY Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis	-13; -12.8	—
SECONDARY Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis	1.5; -2.9	—

Eligibility Criteria

Inclusion criteria

Participants with hypercholesterolemia and established coronary heart disease (CHD) or CHD risk equivalents who were not adequately controlled with a maximally tolerated daily dose of statin at stable dose for at least 4 weeks prior to the screening visit (Week -2).

Exclusion criteria

Age 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01644188). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.