Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects -2 (GAUSS-2)

Amgen

Status and phase: Completed; Phase 3

Conditions: Hyperlipidemia

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01763905

2012-001364-30 (EudraCT Number)

20110116

Details and patient eligibility

About

The primary objective was to evaluate the effect of 12 weeks of subcutaneous (SC) evolocumab every 2 weeks (Q2W) and monthly (QM), compared with ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in hypercholesterolemic adults unable to tolerate an effective dose of a statin (HMG-CoA (5-hydroxy-3-methylglutaryl-coenzyme A) reductase inhibitors).

Enrollment: 307 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female ≥ 18 to ≤ 80 years of age
• Not on a statin or on a low dose statin with stable dose for at least 4 weeks
• History of intolerance to at least 2 statins
• Subject not at LDL-C goal
• Lipid lowering therapy has been stable prior to enrolment for at least 4 weeks.
• Fasting triglycerides ≤ 400 mg/dL

Exclusion criteria

• New York Heart Association (NYHA) III or IV heart failure
• Uncontrolled cardiac arrhythmia
• Uncontrolled hypertension
• Type 1 diabetes, poorly controlled type 2 diabetes
• Uncontrolled hypothyroidism or hyperthyroidism

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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307 participants in 4 patient groups

Ezetimibe (Q2W)

Active Comparator group

Description:

Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.

Treatment:

Drug: Placebo to Evolocumab

Drug: Ezetimibe

Ezetimibe (QM)

Active Comparator group

Description:

Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.

Treatment:

Drug: Placebo to Evolocumab

Drug: Ezetimibe

Evolocumab Q2W

Experimental group

Description:

Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.

Treatment:

Drug: Placebo to Ezetimibe

Biological: Evolocumab

Evolocumab QM

Experimental group

Description:

Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.

Treatment:

Drug: Placebo to Ezetimibe

Biological: Evolocumab