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NCT03361501 · ClinicalTrials.gov registry record · Phase 3
A Phase 3 STudy of CaPRe in LOwering Very hiGh TriglYcerides (TRILOGY 2)
A Phase 3 study, sponsored by Grace Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 278
- Enrollment target
NCT03361501: Completed Phase 3 study, sponsored by Grace Therapeutics.
NCT03361501 is a Phase 3 study that has completed, run by Grace Therapeutics. The registered enrollment target is 278 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03361501, a Phase 3 study, has completed, sponsored by Grace Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 278 participants
- Enrollment target
Study Summary
The primary objective of this study is to determine the efficacy of CaPre 4 g daily, compared to placebo, in lowering fasting TG levels in subjects with fasting TG levels ≥500 mg/dL and ≤1500 mg/dL (≥5.7 mmol/L and ≤17.0 mmol/L) after 12 weeks of treatment. Approximately 615 subjects will be screened to obtain 245 randomized subjects following a treatment allocation ratio of 2.5:1 (CaPre:placebo).
Interventions
- DRUG Placebo
- DRUG CaPre
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 278 participants |
| Start Date | 2018-02-01 |
| Est. Completion | 2020-01-09 |
| Phase | Phase 3 |
What the finished NCT03361501 record still lists
NCT03361501 is an interventional study that assigns participants to a tested intervention. The registered 278 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (64% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03361501 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03361501 about?
NCT03361501 is a clinical study titled "A Phase 3 STudy of CaPRe in LOwering Very hiGh TriglYcerides (TRILOGY 2)". The primary objective of this study is to determine the efficacy of CaPre 4 g daily, compared to placebo, in lowering fasting TG levels in subjects with fasting TG levels ≥500 mg/dL and ≤1500 mg/dL (≥5.7 mmol/L and ≤17.0 mmol/L) after 12 weeks of treatment. Approximately 615 subjects will be screen...
What is the current status of trial NCT03361501?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 278 participants. The study started on 2018-02-01. Estimated completion is 2020-01-09.
What interventions are being tested in trial NCT03361501?
The interventions under investigation include: Placebo (DRUG), CaPre (DRUG).
Who is sponsoring clinical trial NCT03361501?
This trial is sponsored by Grace Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03361501's enrollment target sits among peer trials
278 1200th of 2000 higher than 799 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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