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

January 25, 2022 updated by: Ionis Pharmaceuticals, Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

89

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Chicoutimi, Quebec, Canada
        • Isis Investigational Site
  • United States
    • North Carolina
      • Farmville, North Carolina, United States, 27828
        • Farmville Internal Medicine
      • Greenville, North Carolina, United States, 27834
        • Mark R. Cervi
      • Greenville, North Carolina, United States, 27834
        • Physicians East, Quadrangle Medical Specialists
      • Greenville, North Carolina, United States, 27858
        • Carolina East Family Medicine
      • Kinston, North Carolina, United States, 28504
        • Eastern Carolina Physicians
      • Wilson, North Carolina, United States, 27893
        • Natalie A Doyle, MD PA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 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 3
Stable dose of fibrate
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 4
Fredrickson Type 1 dyslipidemia
Drug: ISIS apoC-III Rx
Dose 1
Drug: ISIS apoC-III Rx
Dose 2
Drug: ISIS apoC-III Rx
Dose 3

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VLDL apoC-III
Time Frame: 92 Days
The effect of treatment with ISIS ApoC-III Rx or Placebo on fasting total apoC-III levels.
92 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ionis Pharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (ACTUAL)

January 1, 2014

Study Completion (ACTUAL)

January 1, 2014

Study Registration Dates

First Submitted

February 6, 2012

First Submitted That Met QC Criteria

February 7, 2012

First Posted (ESTIMATE)

February 8, 2012

Study Record Updates

Last Update Posted (ACTUAL)

January 27, 2022

Last Update Submitted That Met QC Criteria

January 25, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISIS 304801-CS2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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