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NCT03385239 · ClinicalTrials.gov registry record · Phase 2
Study of ISIS 678354 (AKCEA-APOCIII-LRx) in Participants With Hypertriglyceridemia and Established Cardiovascular Disease (CVD)
A Phase 2 study, sponsored by Akcea Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 114
- Enrollment target
NCT03385239: Completed Phase 2 study, sponsored by Akcea Therapeutics.
NCT03385239 is a Phase 2 study that has completed, run by Akcea Therapeutics. The registered enrollment target is 114 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (14% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03385239, a Phase 2 study, has completed, sponsored by Akcea Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 114 participants
- Enrollment target
Study 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.
Primary Outcome
An analysis of covariance (ANCOVA) model was performed on the log ratio of TG value at the Primary Analysis Time Point to TG value at Baseline. The estimate of the log ratio was converted back to the original scale and percent change was calculated using formula: (ratio of TG value at the Primary Analysis Time Point to TG value at Baseline - 1) × 100.
Interventions
- DRUG Placebo
- DRUG ISIS 678354
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 114 participants |
| Start Date | 2018-01-30 |
| Est. Completion | 2020-02-25 |
| Phase | Phase 2 |
What the finished NCT03385239 record still lists
NCT03385239 is an interventional study that assigns participants to a tested intervention. The registered 114 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (14% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03385239 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03385239 about?
NCT03385239 is a clinical study titled "Study of ISIS 678354 (AKCEA-APOCIII-LRx) in Participants With Hypertriglyceridemia and Established Cardiovascular Disease (CVD)". 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 wit...
What is the current status of trial NCT03385239?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 114 participants. The study started on 2018-01-30. Estimated completion is 2020-02-25.
What interventions are being tested in trial NCT03385239?
The interventions under investigation include: Placebo (DRUG), ISIS 678354 (DRUG).
Who is sponsoring clinical trial NCT03385239?
This trial is sponsored by Akcea Therapeutics, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03385239's enrollment target sits among peer trials
114 627th of 2000 higher than 1,370 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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