Phase 2
Completed N=46
A Multiple Dose Study Of PF-04950615 (RN316) In Subjects On Maximum Doses Of Statins
Source: ClinicalTrials.gov NCT01350141 ↗Enrolled (actual)
46
Serious AEs
2.2%
Results posted
Nov 2017
Primary outcomePrimary: Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Day 85 — 4.05; -14.95; -44.84 percent change — p=0.0137
Summary
PF-04950615 is a new investigational hypercholesterolemic agent that is being tested in this study to evaluate if it can lower LDL cholesterol.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Day 85 |
4.05; -14.95; -44.84 | 0.0137 sig |
| SECONDARY Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than 70 and Less Than 100 Milligram Per Deciliter (mg/dL) |
0.0; 20.0; 80.0; 15.4; 86.7; 100 | 0.1900 |
| SECONDARY Percentage of Participants Achieving at Least 30 Percent Decrease in Low-density Lipoprotein Cholesterol (LDL-C) |
0.0; 13.3; 100; 8.3; 26.7; 75.0 | 0.2928 |
| SECONDARY Change From Baseline in Lipid Parameters at Day 29, 57 and 85 |
50.71; 50.63; 48.38; 191.14; 189.07; 195.34 | — |
| SECONDARY Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 |
0.50; -1.09; 11.93; 0.64; -12.63; -35.00 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) |
9; 12; 9; 0; 1; 0 | — |
| SECONDARY Number of Treatment-Emergent Adverse Events (TEAEs) by Severity |
12; 34; 20; 2; 19; 7 | — |
| SECONDARY Number of Participants With Clinically Significant Laboratory Abnormalities |
12; 15; 16 | — |
| SECONDARY Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters |
0; 2; 2; 2; 0; 3 | — |
| SECONDARY Number of Participants With Anti-drug (Anti-PF-04950615) Antibody (ADA) |
0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Body Mass Index (BMI) of 18.5 to 40 kg/m2
- On a stable maximum daily dose of a statin, defined as atorvastatin 80 mg or rosuvastatin 40 mg for a minimum of 45 days prior to Day 1.
- Lipids meet the following criteria twice during screening period:
- Fasting LDL C = or > 80 mg/dL;
- Fasting TG 400 mg/dL
- 12 lead ECG demonstrating QTcFF >455 msec at screening.
Data sourced from ClinicalTrials.gov (NCT01350141). 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.