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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Isis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01529424
First received: February 6, 2012
Last updated: January 31, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Hypertriglyceridemia
Drug: ISIS apoC-III Rx
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Isis Pharmaceuticals:

Primary Outcome Measures:
  • VLDL apoC-III [ Time Frame: 92 Days ] [ Designated as safety issue: No ]
    The effect of treatment with ISIS ApoC-III Rx or Placebo on fasting total apoC-III levels.


Estimated Enrollment: 102
Study Start Date: February 2012
Estimated Study Completion Date: March 2014
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
Non-extensive PK/non post-prandial
Drug: ISIS apoC-III Rx
Dose 1
Drug: ISIS apoC-III Rx
Dose 2
Drug: ISIS apoC-III Rx
Dose 3
Drug: Placebo
Dose 1
Drug: Placebo
Dose 2
Drug: Placebo
Dose 3
Experimental: Group 2a
Extensive PK
Drug: ISIS apoC-III Rx
Dose 1
Drug: ISIS apoC-III Rx
Dose 2
Drug: ISIS apoC-III Rx
Dose 3
Drug: Placebo
Dose 1
Drug: Placebo
Dose 2
Drug: Placebo
Dose 3
Experimental: Group 2b
Post-prandial assessment
Drug: ISIS apoC-III Rx
Dose 2
Drug: ISIS apoC-III Rx
Dose 3
Drug: Placebo
Dose 2
Drug: Placebo
Dose 3
Experimental: Group 3
Stable dose of fibrate
Drug: ISIS apoC-III Rx
Dose 2
Drug: ISIS apoC-III Rx
Dose 3
Drug: Placebo
Dose 2
Drug: Placebo
Dose 3
Experimental: Group 4
Fredrickson Type 1 dyslipidemia
Drug: ISIS apoC-III Rx
Dose 3

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01529424

Locations
United States, North Carolina
Farmville Internal Medicine
Farmville, North Carolina, United States, 27828
Mark R. Cervi
Greenville, North Carolina, United States, 27834
Physicians East, Quadrangle Medical Specialists
Greenville, North Carolina, United States, 27834
Carolina East Family Medicine
Greenville, North Carolina, United States, 27858
Eastern Carolina Physicians
Kinston, North Carolina, United States, 28504
Natalie A Doyle, MD PA
Wilson, North Carolina, United States, 27893
Canada, Quebec
Isis Investigational site
Chicoutimi, Quebec, Canada
Sponsors and Collaborators
Isis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Isis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01529424     History of Changes
Other Study ID Numbers: ISIS 304801-CS2
Study First Received: February 6, 2012
Last Updated: January 31, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Isis Pharmaceuticals:
Hypertriglyceridemia

Additional relevant MeSH terms:
Hypertriglyceridemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on August 20, 2014