Phase 3
Completed N=61
Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-4
Source: ClinicalTrials.gov NCT02634580 ↗Enrolled (actual)
61
Serious AEs
5.0%
Results posted
Aug 2018
Primary outcomePrimary: Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at the Mean of Weeks 10 and 12 — -20.39; -59.75 percent change — p=<0.0001
◆ Published Evidence
Established
29citations · ~5 / year
Evolocumab vs. Ezetimibe in Statin-Intolerant Hyperlipidemic Japanese Patients: Phase 3 GAUSS-4 Trial.
Summary
The primary objective of the study was to evaluate the effect of 12 weeks of subcutaneous (SC) evolocumab 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.
Linked Publications
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Evolocumab vs. Ezetimibe in Statin-Intolerant Hyperlipidemic Japanese Patients: Phase 3 GAUSS-4 Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at the Mean of Weeks 10 and 12 |
-20.39; -59.75 | <0.0001 sig |
| PRIMARY Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 |
-19.13; -59.27 | < 0.0001 sig |
| SECONDARY Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 |
-35.6; -113.2 | <0.0001 sig |
| SECONDARY Change From Baseline in LDL-C at Week 12 |
-33.4; -112.7 | <0.0001 sig |
| SECONDARY Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL |
0.00; 56.41 | <0.0001 sig |
| SECONDARY Percentage of Participants Who Achieved a LDL-C of Less Than 70 mg/dL at Week 12 |
0.00; 52.63 | < 0.0001 sig |
| SECONDARY Percent Change From Baseline in Total Cholesterol at the Mean of Weeks 10 and 12 |
-13.80; -39.24 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Total Cholesterol at Week 12 |
-12.69; -38.52 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12 |
-18.82; -52.35 | < 0.0001 sig |
| SECONDARY Percent Change From Baseline in Non-HDL-C at Week 12 |
-18.28; -51.71 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12 |
-13.23; -48.90 | < 0.0001 sig |
| SECONDARY Percent Change From Baseline in Apolipoprotein B at Week 12 |
-11.32; -47.91 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12 |
-15.73; -44.34 | < 0.0001 sig |
| SECONDARY Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12 |
-17.34; -44.39 | < 0.0001 sig |
| SECONDARY Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at the Mean of Weeks 10 and 12 |
-15.39; -52.46 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at Week 12 |
-15.62; -51.91 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12 |
-5.89; -37.02 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Lipoprotein(a) at Week 12 |
-5.21; -36.41 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12 |
-5.21; -1.73 | 0.63 |
| SECONDARY Percent Change From Baseline in Triglycerides at Week 12 |
-9.87; 1.92 | 0.22 |
| SECONDARY Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12 |
3.10; 11.06 | 0.012 sig |
| SECONDARY Percent Change From Baseline in HDL-C at Week 12 |
6.45; 12.04 | 0.086 |
| SECONDARY Percent Change From Baseline in VLDL-C at the Mean of Weeks 10 and 12 |
-4.67; -5.34 | 0.93 |
| SECONDARY Percent Change From Baseline in VLDL-C at Week 12 |
-9.06; -1.42 | 0.44 |
Eligibility Criteria
Inclusion Criteria
- Male or female ≥ 20 to ≤ 80 years of age
- Japanese by self-identification
- Not on a statin or on a low dose statin with stable dose for at least 4 weeks.
- Subject not at LDL-C goal
- History of statin intolerance to at least 2 statins
- Lipid lowering therapy has been stable prior to screening 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
Data sourced from ClinicalTrials.gov (NCT02634580) and the linked publication. 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.