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

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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.


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
Kinston, North Carolina 28504
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Kinston, NC
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Farmville, North Carolina 27828
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Farmville, NC
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Greenville, North Carolina 27834
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Greenville, NC
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Greenville, North Carolina 27834
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Greenville, NC
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Greenville, North Carolina 27858
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Greenville, NC
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Wilson, North Carolina 27893
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Wilson, NC
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