Evaluation of Alirocumab in Addition to Lipid-Modifying Therapy in Patients With High Cardiovascular Risk and Hypercholesterolemia in South Korea and Taiwan

Sanofi

Status and phase: Completed; Phase 3

Conditions: Hypercholesterolemia

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02289963

U1111-1157-3294 (Other Identifier)

EFC14074

Details and patient eligibility

About

Primary Objective:

To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as add-on therapy to stable maximally tolerated daily statin therapy with or without other lipid-modifying therapy (LMT) in comparison with placebo after 24 weeks of treatment in high cardiovascular risk participants with hypercholesterolemia in South Korea and Taiwan.

Secondary Objectives:

• To evaluate the effect of alirocumab in comparison with placebo on LDL-C after 12 weeks of treatment.
• To evaluate the effect of alirocumab on other lipid parameters: apolipoprotein B (Apo B), non high-density lipoprotein cholesterol (non-HDL-C), total cholesterol (TC), lipoprotein (a) (Lp [a]), high-density lipoprotein cholesterol (HDL-C), triglycerides (TGs), and apolipoprotein A-1 (Apo A-1).
• To evaluate the safety and tolerability of alirocumab.
• To evaluate the development of anti-alirocumab antibodies (ADA).

Full description

The maximum study duration was approximately 35 weeks per participant, including up to 3 weeks screening period, 24 weeks double-blind treatment period, and 8 weeks follow-up period.

Enrollment: 199 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Participants with hypercholesterolemia and established coronary heart disease (CHD) or CHD risk equivalents who are not adequately controlled with a maximally tolerated daily dose of statin with or without other LMT, both at stable dose for at least 4 weeks prior to screening visit (Week -3).

Exclusion criteria

• Aged <18 years or legal age of adulthood, whichever was greater.
• Participants without established CHD or CHD risk equivalent.
• LDL-C <70 mg/dL (<1.81 mmol/L) in participants with a history of documented cardiovascular disease.
• LDL-C <100 mg/dL (<2.59 mmol/L) in participants without a history of documented cardiovascular disease.
• Not on a stable dose of LMT (including statin) for at least 4 weeks prior to the screening visit (Week -3) or between screening to randomization visits.
• Currently taking a statin other than atorvastatin, rosuvastatin or simvastatin.
• Atorvastatin, rosuvastatin or simvastatin was not taken daily or not taken at a registered dose.
• Daily doses above atorvastatin 80 mg, rosuvastatin 20 mg or simvastatin 40 mg.
• Fasting serum triglycerides >400 mg/dL (>4.52 mmol/L) at the screening period.

The above information is not intended to contain all considerations relevant to a participants'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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199 participants in 2 patient groups, including a placebo group

Placebo Q2W

Placebo Comparator group

Description:

Placebo (for alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.

Treatment:

Drug: Lipid-Modifying Therapy (LMT)

Drug: Placebo (for Alirocumab)

Alirocumab 75 mg Q2W/Up to 150 mg Q2W

Placebo Comparator group

Description:

Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.

Treatment:

Drug: Lipid-Modifying Therapy (LMT)

Drug: Alirocumab