At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 114 enrolled
Drug / intervention
ISIS 678354 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind, Placebo-Controlled, Dose-Ranging Phase 2 Study of ISIS 678354 Administered Subcutaneously to Patients With Hypertriglyceridemia and Established Cardiovascular Disease (CVD) or at a High Risk for CVD
In Brief
A Phase 2 clinical trial evaluating ISIS 678354 and Placebo for Hypertriglyceridemia and Cardiovascular Diseases. Completed, enrolled 114 participants across 31 sites in 2 countries.
Detailed Summary
This was a multicenter, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the safety, including tolerability, of ISIS 678354 and to assess the efficacy of different doses and dosing regimens of ISIS 678354 for reduction of serum triglyceride (TG) levels in participants with hypertriglyceridemia and established CVD or at a high risk for CVD.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertriglyceridemia, Cardiovascular Diseases
CountriesCanada, United States
CollaboratorsIonis Pharmaceuticals, Inc.
Timeline
Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedDec 2017
Enrollment StartJan 2018
Primary CompletionNov 2019
Study CompletionFeb 2020
TodayJul 2026
First PostedDec 28, 2017
Enrollment StartJan 30, 2018
Primary CompletionNov 25, 2019
Study CompletionFeb 25, 2020
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 8.5 years ago
Interventions
ISIS 678354drug
ISIS 678354 solution for SC injection.
Placebodrug
Sterile Normal Saline (0.9% NaCl).