Clinical trial NCT01529424: Safety, Tolerability, and Pharmacokinetic Study of ISIS ApoC-III Rx in Hypertriglyceridemia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypertriglyceridemia
Keywords: Hypertriglyceridemia
Lead sponsor: Ionis Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2012-02-08
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: VLDL apoC-III
timeFrame: 92 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Farmville
country: United States
facility: Farmville Internal Medicine
state: North Carolina
city: Greenville
country: United States
facility: Mark R. Cervi
state: North Carolina
city: Greenville
country: United States
facility: Physicians East, Quadrangle Medical Specialists
state: North Carolina
city: Greenville
country: United States
facility: Carolina East Family Medicine
state: North Carolina
city: Kinston
country: United States
facility: Eastern Carolina Physicians
state: North Carolina
city: Wilson
country: United States
facility: Natalie A Doyle, MD PA
state: North Carolina
city: Chicoutimi
country: Canada
facility: Isis Investigational site
state: Quebec
Study officials:
References:
citation: Gaudet D, Alexander VJ, Baker BF, Brisson D, Tremblay K, Singleton W, Geary RS, Hughes SG, Viney NJ, Graham MJ, Crooke RM, Witztum JL, Brunzell JD, Kastelein JJ. Antisense Inhibition of Apolipoprotein C-III in Patients with Hypertriglyceridemia. N Engl J Med. 2015 Jul 30;373(5):438-47. doi: 10.1056/NEJMoa1400283.