NCT03361501

A Phase 3 STudy of CaPRe in LOwering Very hiGh TriglYcerides (TRILOGY 2)

A Phase 3, Multi-center, Multi-national, 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: 278 (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 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).

Conditions

• Hypertriglyceridemia

Interventions

Type	Name	Description
DRUG	CaPre	4 x 1 g capsules administered orally once daily for 26 weeks
DRUG	Placebo	4 x 1 g capsules administered orally once daily for 26 weeks

Timeline

• Start date: 2018-02-01
• Primary completion: 2019-09-24
• Completion: 2020-01-09
• First posted: 2017-12-05
• Last updated: 2020-08-12

Locations

68 sites across 3 countries: United States, Canada, Mexico

Regulatory

• FDA-regulated drug study