Phase 1
Completed N=60
Ascending Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Evolocumab (AMG 145) in Adults With Hyperlipidemia on Stable Doses of a Statin
Source: ClinicalTrials.gov NCT01133522 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Oct 2015
Primary outcomePrimary: Number of Participants With Adverse Events — 7; 2; 5; 4 participants
Summary
The purpose of the study is to evaluate the safety and tolerability of multiple doses of evolocumab when given as an add-on to stable statin therapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
7; 2; 5; 4; 6; 3 | — |
| PRIMARY Number of Participants With Anti-Evolocumab Antibodies |
0; 0; 0; 1; 0; 0 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of Evolocumab |
20.3; 62.8; 63.6; 16.3; 14.7 | — |
| SECONDARY Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Evolocumab |
226; 1200; 903; 181; 165 | — |
| SECONDARY Percent Change From Baseline to End of the Dosing Interval in LDL-C |
3.14; -23.79; -51.76; -69.58; -74.65; -62.01 | — |
| SECONDARY Percent Change From Baseline to End of the Dosing Interval in PCSK9 |
6.00; -42.07; -64.46; -70.42; -91.49; -32.72 | — |
Eligibility Criteria
Inclusion Criteria
- Men and women ages 18 to 70 years (inclusive) at the time of screening with hyperlipidemia
- Body mass index (BMI) ≥18 and ≤ 35 kg/m^2 at the time of screening
- Low-density lipoprotein cholesterol (LDL-C) level of 70-220 mg/dL (inclusive) at screening as measured by direct assay
- For Cohorts 1-5: On a stable dose of rosuvastatin (Crestor) 8.0% at screening
- use of any hypoglycemic medication other than metformin
- Uncontrolled hypertension (systolic blood pressure ≥ 150 or diastolic blood pressure ≥ 90 mmHg) either on or off therapy at screening or at baseline
Data sourced from ClinicalTrials.gov (NCT01133522). 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.