NCT01529424

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2012

Geographic Reach
2 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

February 6, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 8, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

January 27, 2022

Status Verified

January 1, 2022

Enrollment Period

1.9 years

First QC Date

February 6, 2012

Last Update Submit

January 25, 2022

Conditions

Hypertriglyceridemia

Keywords

Hypertriglyceridemia

Outcome Measures

Primary Outcomes (1)

  • VLDL apoC-III

    The effect of treatment with ISIS ApoC-III Rx or Placebo on fasting total apoC-III levels.

    92 Days

Study Arms (5)

Group 1

EXPERIMENTAL

Non-extensive PK/non post-prandial

Drug: ISIS apoC-III RxDrug: Placebo

Group 2a

EXPERIMENTAL

Extensive PK

Drug: ISIS apoC-III RxDrug: Placebo

Group 2b

EXPERIMENTAL

Post-prandial assessment

Drug: ISIS apoC-III RxDrug: Placebo

Group 3

EXPERIMENTAL

Stable dose of fibrate

Drug: ISIS apoC-III RxDrug: Placebo

Group 4

EXPERIMENTAL

Fredrickson Type 1 dyslipidemia

Drug: ISIS apoC-III Rx

Interventions

ISIS apoC-III RxDRUG

Dose 1

Group 1Group 2a
PlaceboDRUG

Dose 1

Group 1Group 2a

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Severe hypertriglyceridemia

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Farmville Internal Medicine

Farmville, North Carolina, 27828, United States

Location

Mark R. Cervi

Greenville, North Carolina, 27834, United States

Location

Physicians East, Quadrangle Medical Specialists

Greenville, North Carolina, 27834, United States

Location

Carolina East Family Medicine

Greenville, North Carolina, 27858, United States

Location

Eastern Carolina Physicians

Kinston, North Carolina, 28504, United States

Location

Natalie A Doyle, MD PA

Wilson, North Carolina, 27893, United States

Location

Isis Investigational site

Chicoutimi, Quebec, Canada

Location

Related Publications (1)

  • 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.

    PMID: 26222559DERIVED

MeSH Terms

Conditions

Hypertriglyceridemia

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2012

First Posted

February 8, 2012

Study Start

February 1, 2012

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

January 27, 2022

Record last verified: 2022-01

Locations

US(6)CA(1)