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Completed Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT03398005

Public ClinicalTrials.gov record NCT03398005. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 31, 2026, 12:36 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID
NCT03398005
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Grace Therapeutics Inc.
Industry
Enrollment
256 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 23, 2018 (Actual)
Primary completion
Jul 21, 2019 (Actual)
Completion
Nov 20, 2019 (Actual)
Last update posted
Jan 18, 2020

2018 – 2019

United States locations

U.S. sites
69
U.S. states
26
U.S. cities
60
Facility City State ZIP Site status
Research site Birmingham Alabama 35242 —
Research site Tucson Arizona 85712 —
Research site Conway Arkansas 72034 —
Research site El Cajon California 92020 —
Research site Fresno California 93702 —
Research site Garden Grove California 92844 —
Research site Lomita California 90717 —
Research site Newport Beach California 92663 —
Research site Tustin California 92780 —
Research site Boca Raton Florida 33487 —
Research site Clearwater Florida 33765 —
Research site Fort Myers Florida 33912 —
Research site Hialeah Florida 33012 —
Research site Homestead Florida 33030 —
Research site Jacksonville Florida 32256 —
Research site Kendall Florida 33175 —
Research site Lake Worth Florida 33461 —
Research site Miami Florida 33125 —
Research site Miami Florida 33126 —
Research site Miami Florida 33135 —
Research site Miami Florida 33144 —
Research site Miami Florida 33155 —
Research site Miami Florida 33165 —
Research site Miami Florida 33173 —
Research site Miami Springs Florida 33166 —
Research site North Miami Beach Florida 33162 —
Research site Orlando Florida 32825 —
Research site Pembroke Pines Florida 33026 —
Research site Tamarac Florida 33321 —
Research site Tampa Florida 33603 —
Research site Wellington Florida 33449 —
Research site West Palm Beach Florida 33401 —
Research site West Palm Beach Florida 33409 —
Research site Atlanta Georgia 30345 —
Research site Gainesville Georgia 30501 —
Research site Savannah Georgia 31406 —
Research site Snellville Georgia 30078 —
Research site Sugar Hill Georgia 30518 —
Research site Meridian Idaho 83642 —
Research site Meridian Idaho 83646 —
Research site Gurnee Illinois 60031 —
Research site Anderson Indiana 46011 —
Research site Louisville Kentucky 40213 —
Research site Eunice Louisiana 70535 —
Research site Cadillac Michigan 49601 —
Research site Jackson Mississippi 39202 —
Research site Olive Branch Mississippi 38654 —
Research site St Louis Missouri 63117 —
Research site Omaha Nebraska 68114 —
Research site Greensboro North Carolina 27408 —
Research site Mooresville North Carolina 28117 —
Research site Canton Ohio 44710 —
Research site Marion Ohio 43302 —
Research site Maumee Ohio 43537 —
Research site Norman Oklahoma 73069 —
Research site Beaver Pennsylvania 15009 —
Research site Spartanburg South Carolina 29301 —
Research site Chattanooga Tennessee 37421 —
Research site Memphis Tennessee 38119 —
Research site Arlington Texas 76012 —
Research site Houston Texas 77084 —
Research site Houston Texas 77089 —
Research site Lampasas Texas 76550 —
Research site San Antonio Texas 78258 —
Research site Salt Lake City Utah 84107 —
Research site West Jordan Utah 84088 —
Research site Danville Virginia 24541 —
Research site Bellevue Washington 98007 —
Research site Kenosha Wisconsin 53144 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03398005, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 18, 2020 · Synced Oct 31, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03398005 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →