Adults 18 to 80, any sex, with Diabetes, Hyperlipidemia, Mixed Dyslipidemia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12Primary· Baseline and weeks 10 and 12
Group
Value
95% CI
Placebo Q2W
4.94
± 3.48
Placebo QM
0.99
± 3.31
Evolocumab Q2W
-65.35
± 3.09
Evolocumab QM
-69.05
± 2.96
Percent Change From Baseline in LDL-C at Week 12Primary· Baseline and week 12
Group
Value
95% CI
Placebo Q2W
7.10
± 3.66
Placebo QM
2.63
± 3.41
Evolocumab Q2W
-64.66
± 3.20
Evolocumab QM
-62.30
± 3.02
Change From Baseline in LDL-C at the Mean of Weeks 10 and 12Secondary· Baseline and weeks 10 and 12
Group
Value
95% CI
Placebo Q2W
-2.1
± 4.1
Placebo QM
-8.8
± 4.0
Evolocumab Q2W
-64.6
± 3.6
Evolocumab QM
-71.9
± 3.6
Change From Baseline in LDL-C at Week 12Secondary· Baseline and week 12
Group
Value
95% CI
Placebo Q2W
-0.3
± 4.2
Placebo QM
-7.3
± 4.1
Evolocumab Q2W
-63.9
± 3.7
Evolocumab QM
-66.1
± 3.7
Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12Secondary· Baseline and weeks 10 and 12
Group
Value
95% CI
Placebo Q2W
4.33
± 3.05
Placebo QM
0.33
± 2.95
Evolocumab Q2W
-56.57
± 2.70
Evolocumab QM
-59.08
± 2.63
Percent Change From Baseline in Non-HDL-C at Week 12Secondary· Baseline and week 12
Group
Value
95% CI
Placebo Q2W
5.87
± 3.20
Placebo QM
1.30
± 3.03
Evolocumab Q2W
-55.76
± 2.79
Evolocumab QM
-52.92
± 2.69
Percent Change From Baseline in Apolipoprotein B100 at the Mean of Weeks 10 and 12Secondary· Baseline and weeks 10 and 12
Group
Value
95% CI
Placebo Q2W
1.97
± 3.31
Placebo QM
-1.52
± 2.99
Evolocumab Q2W
-54.96
± 3.07
Evolocumab QM
-56.37
± 2.72
Percent Change From Baseline in Apolipoprotein B100 at Week 12Secondary· Baseline and week 12
Group
Value
95% CI
Placebo Q2W
3.17
± 3.42
Placebo QM
-0.26
± 3.03
Evolocumab Q2W
-53.90
± 3.14
Evolocumab QM
-49.68
± 2.75
Percent Change From Baseline in Total Cholesterol at the Mean of Weeks 10 and 12Secondary· Baseline and weeks 10 and 12
Group
Value
95% CI
Placebo Q2W
2.89
± 2.30
Placebo QM
-0.25
± 2.18
Evolocumab Q2W
-38.64
± 2.04
Evolocumab QM
-39.74
± 1.95
Percent Change From Baseline in Total Cholesterol at Week 12Secondary· Baseline and week 12
Group
Value
95% CI
Placebo Q2W
4.40
± 2.40
Placebo QM
0.67
± 2.24
Evolocumab Q2W
-37.82
± 2.10
Evolocumab QM
-35.22
± 1.99
Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12Secondary· Baseline and weeks 10 and 12
Group
Value
95% CI
Placebo Q2W
3.03
± 2.38
Placebo QM
-2.03
± 2.41
Evolocumab Q2W
-41.06
± 2.11
Evolocumab QM
-45.70
± 2.17
Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12Secondary· Baseline and week 12
Group
Value
95% CI
Placebo Q2W
3.22
± 2.49
Placebo QM
-1.22
± 2.47
Evolocumab Q2W
-40.72
± 2.18
Evolocumab QM
-41.78
± 2.21
Adverse events — posted to ClinicalTrials.gov
Time frame: From the first dose of study drug to 30 days after last dose; up to 14 weeks..
Reporting threshold: 2%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The primary objective of this study was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145) in combination with statin therapy (atorvastatin) on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in diabetic adults with hyperlipidemia or mixed dyslipidemia.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06081153 — Mechanistic Clinical Trial of PCSK9 Inhibition for AAA
· EARLY_PHASE1
· not yet recruiting
NCT06858332 — Lipoprotein(a) Levels in Patients With Atherosclerotic Cardiovascular Diseases in Russia
· recruiting
NCT06284564 — A Phase II Study Bolstering Outcomes by Optimizing Immunotherapy Strategies With Evolocumab and Nivolumab in Patients Wi
· Phase 2
· active not recruiting
NCT06134635 — Short-term Effect of PCSK9 Inhibitor in Patients With Acute Ischemic Stroke
· unknown
NCT05974345 — In Silico Study Assessing the Impact of Inclisiran on Major Adverse Cardiovascular Events in Patients With Established C
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Amgen
Last refreshed: 11 January 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02662569.