Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects (GAUSS)

Amgen

Status and phase: Completed; Phase 2

Conditions: Hyperlipidemia

Treatments: Drug: Ezetimibe; Other: Placebo to Evolocumab; Biological: Evolocumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01375764

20090159

Details and patient eligibility

About

The primary objective was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145), compared with ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in patients with hypercholesterolemia unable to tolerate an effective dose of a statin.

Enrollment: 160 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female ≥ 18 to ≤ 75 years of age
• On a statin or a low dose statin with stable dose for at least 4 weeks
• Lipid lowering therapy has been stable prior to enrollment
• Fasting triglycerides must be < 400 mg/dL.
• Subject not at LDL-C goal

Exclusion criteria

• New York Heart Association (NYHA) III or IV heart failure or known left ventricular ejection fraction < 30%
• Uncontrolled cardiac arrhythmia
• Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 3 months prior to randomization
• Type 1 diabetes or newly diagnosed type 2 diabetes (HbA1c > 8.5%)
• Uncontrolled hypertension

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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160 participants in 5 patient groups

Ezetimibe

Active Comparator group

Description:

Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.

Treatment:

Other: Placebo to Evolocumab

Drug: Ezetimibe

Evolocumab + Ezetimibe

Experimental group

Description:

Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.

Treatment:

Biological: Evolocumab

Drug: Ezetimibe

Evolocumab 280 mg

Experimental group

Description:

Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.

Treatment:

Biological: Evolocumab

Evolocumab 350 mg

Experimental group

Description:

Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.

Treatment:

Biological: Evolocumab

Evolocumab 420 mg

Experimental group

Description:

Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.

Treatment:

Biological: Evolocumab