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

NCT03361501 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 278

Last updated 2020-08-12

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 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

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

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
2018-02-01
Primary Completion
2019-09-24
Completion
2020-01-09
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Mexico

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 NCT03361501 on ClinicalTrials.gov