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

Phase 2

Completed

• Conditions: Hypertriglyceridemia
• Interventions: Drug: ISIS apoC-III Rx; Drug: Placebo

• Registration Number: NCT01529424
• Lead Sponsor: Ionis Pharmaceuticals, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-02-06
• Study First Submitted QC: 2012-02-07
• Study First Posted: 2012-02-08
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Disposition First Submitted: 2016-06-14
• Disposition First Submitted QC: 2016-06-14
• Disposition First Posted: 2016-06-16
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-25
• Last Update Posted: 2022-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Placebo	Non-extensive PK/non post-prandial
Group 2a	ISIS apoC-III Rx	Extensive PK
Group 1	ISIS apoC-III Rx	Non-extensive PK/non post-prandial
Group 3	Placebo	Stable dose of fibrate
Group 4	ISIS apoC-III Rx	Fredrickson Type 1 dyslipidemia
Group 2a	Placebo	Extensive PK
Group 2b	ISIS apoC-III Rx	Post-prandial assessment
Group 2b	Placebo	Post-prandial assessment
Group 3	ISIS apoC-III Rx	Stable dose of fibrate

Primary Outcome Measures

Name	Time	Method
VLDL apoC-III	92 Days	The effect of treatment with ISIS ApoC-III Rx or Placebo on fasting total apoC-III levels.

Trial Locations

Locations (7)

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, United States

Mark R. Cervi; 🇺🇸 Greenville, North Carolina, United States

Farmville Internal Medicine; 🇺🇸 Farmville, North Carolina, United States

Carolina East Family Medicine; 🇺🇸 Greenville, North Carolina, United States

Isis Investigational site; 🇨🇦 Chicoutimi, Quebec, Canada