MedTrace Logo

A Phase 3 STudy of CaPRe In LOwering Very hiGh TriglYcerides (TRILOGY 1)

NCT03398005 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 256

Last updated 2020-01-18

No results posted yet for this study

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

  • Hypertriglyceridemia

Interventions

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

Sponsors & Collaborators

  • Grace Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Dariush Mozaffarian, MD, DrPH · Tufts Friedman School of Nutrition Science and Policy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-23
Primary Completion
2019-07-21
Completion
2019-11-20
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03398005 on ClinicalTrials.gov