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NCT05355402 · ClinicalTrials.gov registry record · Phase 2
A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) in Adults With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease (Established or at Increased Risk for), and/or With Severe Hypertriglyceridemia
A Phase 2 study, sponsored by Ionis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 154
- Enrollment target
NCT05355402: Completed Phase 2 study, sponsored by Ionis Pharmaceuticals.
NCT05355402 is a Phase 2 study that has completed, run by Ionis Pharmaceuticals. The registered enrollment target is 154 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (16% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05355402, a Phase 2 study, has completed, sponsored by Ionis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 154 participants
- Enrollment target
Study Summary
The purpose of the study was to evaluate the effect of olezarsen on percent change in fasting triglyceride (TG) levels compared to placebo at Months 6 and 12 and the proportion of participants who achieve different thresholds in fasting TG. Other objectives were to evaluate the effect of olezarsen on percent change in fasting apolipoprotein C-III (apoC-III), very low-density lipoprotein cholesterol (VLDL-C), remnant cholesterol, non-high-density lipoprotein cholesterol (non-HDL-C), HDL-C, total cholesterol (TC), apolipoprotein B (apoB), low-density lipoprotein cholesterol (LDL-C), and apolipoprotein A-1 (apoA-1).
Primary Outcome
Baseline was defined as the average of the pre-dose measurement on Day 1 and all non-missing measurements from the qualification period. If the Day 1 pre-dose and qualification period measurements were all missing, then the last non-missing measurement from the screening period was used as baseline. Month 6 was defined as the average of Weeks 25 and 27. If 1 of the 2 assessments was missing, then the non-missing assessment was used. Missing data after the last observed value for participants in
Interventions
- DRUG Placebo
- DRUG Olezarsen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 154 participants |
| Start Date | 2022-05-09 |
| Est. Completion | 2023-12-21 |
| Phase | Phase 2 |
What the finished NCT05355402 record still lists
NCT05355402 is an interventional study that assigns participants to a tested intervention. The registered 154 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (16% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05355402 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05355402 about?
NCT05355402 is a clinical study titled "A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) in Adults With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease (Established or at Increased Risk for), and/or With Severe Hypertriglyceridemia". The purpose of the study was to evaluate the effect of olezarsen on percent change in fasting triglyceride (TG) levels compared to placebo at Months 6 and 12 and the proportion of participants who achieve different thresholds in fasting TG. Other objectives were to evaluate the effect of olezarsen o...
What is the current status of trial NCT05355402?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 154 participants. The study started on 2022-05-09. Estimated completion is 2023-12-21.
What interventions are being tested in trial NCT05355402?
The interventions under investigation include: Placebo (DRUG), Olezarsen (DRUG).
Who is sponsoring clinical trial NCT05355402?
This trial is sponsored by Ionis Pharmaceuticals, which has 76 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05355402's enrollment target sits among peer trials
154 448th of 2000 higher than 1,552 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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