Phase 2
Completed N=93
A Multiple Dose Study of PF-04950615 (RN316) in Subjects on High Doses of Statins
Source: ClinicalTrials.gov NCT01342211 ↗Enrolled (actual)
93
Serious AEs
2.2%
Results posted
Oct 2017
Primary outcomePrimary: Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Day 85 — -8.91; -13.11; -8.63; -47.20 percent change — p=0.5661
Summary
This study will investigate the effect of PF-04950615, a new investigational lipid lowering agent, on LDL-C and other lipids.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Day 85 |
-8.91; -13.11; -8.63; -47.20; -56.48 | 0.5661 |
| SECONDARY Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 and <100 Milligram Per Deciliter (mg/dL) |
5.3; 6.3; 11.8; 77.8; 100; 47.4 | 0.8998 |
| SECONDARY Percentage of Participants Achieving at Least 30 Percent Decrease in Low-density Lipoprotein Cholesterol (LDL-C) |
15.8; 25.0; 11.8; 88.9; 100; 11.8 | 0.5436 |
| SECONDARY Change From Baseline in Lipid Parameters at Day 29, 57 and 85 |
46.18; 51.53; 49.11; 50.24; 44.76; 202.82 | — |
| SECONDARY Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 |
1.98; 5.88; 0.27; 9.34; 12.96; -5.03 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) |
14; 13; 13; 11; 11; 0 | — |
| SECONDARY Number of Treatment-Emergent Adverse Events (TEAEs) by Severity |
24; 18; 30; 18; 17; 2 | — |
| SECONDARY Number of Participants With Clinically Relevant Laboratory Abnormalities |
18; 15; 17; 18; 14 | — |
| SECONDARY Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters |
2; 4; 3; 3; 0; 2 | — |
| SECONDARY Number of Participants With Anti-drug Antibody (ADA) |
0; 3; 1; 1 | — |
Eligibility Criteria
Inclusion Criteria
- On a stable daily dose of atorvastatin, rosuvastatin or simvastatin.
- Lipids meet the following criteria at screening and prior to dosing: Fasting LDL-C greater than 100 mg/dL and fasting TG less than 400 mg/dL
Exclusion Criteria
- History of a cardiovascular or cerebrovascular event or procedure during the past year.
- Poorly controlled type 1 or type 2 diabetes mellitus.
- Poorly controlled hypertension.
Data sourced from ClinicalTrials.gov (NCT01342211). 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.