Safety, Tolerability, and Pharmacokinetic Study of ISIS ApoC-III Rx in Hypertriglyceridemia
Status: | Completed |
---|---|
Conditions: | High Cholesterol, Metabolic |
Therapuetic Areas: | Cardiology / Vascular Diseases, Pharmacology / Toxicology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/1/2014 |
Start Date: | February 2012 |
End Date: | March 2014 |
Contact: | Isis Pharmaceuticals |
Email: | info@isisph.com |
Phone: | 800-679-4747 |
A Randomized, Double-Blind, Placebo-Controlled, Dose Response, Phase 2 Study of ISIS 304801 Administered Subcutaneously to Patients With Severe or Uncontrolled Hypertriglyceridemia
The purpose of this study is to evaluate the dose/response pharmacodynamic effects of ISIS
ApoC-III Rx vs. Placebo on fasting total apoC-III levels.
ApoC-III Rx vs. Placebo on fasting total apoC-III levels.
Inclusion Criteria:
- Severe hypertriglyceridemia
Exclusion Criteria:
- HbA1c >/=9.0%, type 1 diabetes, or history of outpatient insulin use for more than 2
weeks in the last year
- Body mass index (BMI) >40 kg/m2
- History of bariatric surgery or currently on weight loss drugs
- Use of oral contraceptives or hormone replacement therapy or statins unless stable
for 3 months prior to dosing
- Group 1 and 2 patients: Use of systemic corticosteroids, fibrates, niacin, fish oil
or other products containing omega-3 fatty acids within 6 weeks of dosing. Group 3
patients: unable to discontinue use of systemic corticosteroids at least 6 weeks
prior to dosing ; use of niacin, fish oil, or other products containing omega-3 fatty
acids unless on a stable well controlled dose for at least 30 days prior to screening
that is not anticipated to change during the study period. Group 4 patients: unable
to discontinue use of systemic corticosteroids at least 6 weeks prior to dosing; use
of fibrates niacin, fish oil, or other products containing omega-3 fatty acids unless
on a stable well controlled dose for at least 30 days prior to screening that is not
anticipated to change during the study period.
- Use of topical corticosteroids, anticoagulants, or drugs or dietary supplements with
potential lipid-altering effects unless dose is stable and well controlled for 30
days prior to dosing
- Any Screening laboratory values that are out of allowed reference ranges
- Inability to comply with protocol or study procedures
- Any other significant illness or condition that may adversely affect the subjects
participation in the study
We found this trial at
6
sites
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)