Trials / Completed
CompletedNCT03398005
A Phase 3 STudy of CaPRe In LOwering Very hiGh TriglYcerides (TRILOGY 1)
A Phase 3, Multi-center, Placebo-controlled, Randomized, Double-blind 26-week Study to Assess the Safety and Efficacy of CaPre® in Patients With Severe Hypertriglyceridemia.
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 256 (actual)
- Sponsor
- Grace Therapeutics Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to determine the efficacy of CaPre 4 g daily, compared to placebo, in lowering fasting triglyceride (TG) levels in patients 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 2.5:1 treatment allocation ratio (CaPre: placebo).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CaPre | 4 x 1 g capsules administered orally once a day for 26 weeks |
| DRUG | Placebo | 4 x 1 g capsules administered orally once a day for 26 weeks |
Timeline
- Start date
- 2018-01-23
- Primary completion
- 2019-07-21
- Completion
- 2019-11-20
- First posted
- 2018-01-12
- Last updated
- 2020-01-18
Locations
69 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03398005. Inclusion in this directory is not an endorsement.