Safety, Tolerability, and Pharmacokinetic Study of ISIS ApoC-III Rx in Hypertriglyceridemia

Hypertriglyceridemia Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Dose Response, Phase 2 Study of ISIS 304801 Administered Subcutaneously to Patients With Severe or Uncontrolled Hypertriglyceridemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01529424
• Other study ID #: ISIS 304801-CS2
• Status: Completed
• Phase: Phase 2
• Start date: February 2012
• Est. completion date: January 2014

Study information

• Verified date: January 2022
• Source: Ionis Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertriglyceridemia

Intervention

Drug:
• ISIS apoC-III Rx
Dose 1
• ISIS apoC-III Rx
Dose 2
• ISIS apoC-III Rx
Dose 3
• Placebo
Dose 1
• Placebo
Dose 2
• Placebo
Dose 3

Locations

Country	Name	City	State
Canada	Isis Investigational site	Chicoutimi	Quebec
United States	Farmville Internal Medicine	Farmville	North Carolina
United States	Carolina East Family Medicine	Greenville	North Carolina
United States	Mark R. Cervi	Greenville	North Carolina
United States	Physicians East, Quadrangle Medical Specialists	Greenville	North Carolina
United States	Eastern Carolina Physicians	Kinston	North Carolina
United States	Natalie A Doyle, MD PA	Wilson	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Ionis Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VLDL apoC-III	The effect of treatment with ISIS ApoC-III Rx or Placebo on fasting total apoC-III levels.	92 Days