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Completed Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT03361501

Public ClinicalTrials.gov record NCT03361501. 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 20, 2026, 6:10 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, Multi-national, 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 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).

Study identification

NCT ID
NCT03361501
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Grace Therapeutics Inc.
Industry
Enrollment
278 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
Feb 1, 2018 (Actual)
Primary completion
Sep 24, 2019 (Actual)
Completion
Jan 9, 2020 (Actual)
Last update posted
Aug 12, 2020

2018 – 2020

United States locations

U.S. sites
53
U.S. states
24
U.S. cities
47
Facility City State ZIP Site status
Research site Birmingham Alabama 35216 —
Research site Childersburg Alabama 35044 —
Research site Encino California 91436 —
Research site Long Beach California 90806 —
Research site San Diego California 92111 —
Research site Thousand Oaks California 91360 —
Research site Torrance California 90503 —
Research site Monument Colorado 80132 —
Research site Clearwater Florida 33756 —
Research site Coral Gables Florida 33134 —
Research site DeLand Florida 32720 —
Research site Fort Lauderdale Florida 33308 —
Research site Jacksonville Florida 32205 —
Research site Jacksonville Florida 32277 —
Research site Miami Florida 33133 —
Research site Miami Florida 33134 —
Research site Miami Florida 33144 —
Research site Miami Lakes Florida 33016 —
Research site Dunwoody Georgia 30338 —
Research site Peachtree Corners Georgia 30071 —
Research site Savannah Georgia 31406 —
Research site Boise Idaho 83712 —
Research site Wauconda Illinois 60084 —
Research site Iowa City Iowa 52242 —
Research site Overland Park Kansas 66210 —
Research site Biddeford Maine 04005 —
Research site Baltimore Maryland 21229 —
Research site Hyattsville Maryland 20782 —
Research site Flint Michigan 48503 —
Research site Tupelo Mississippi 38801 —
Research site Norfolk Nebraska 68701 —
Research site Las Vegas Nevada 89120 —
Research site Las Vegas Nevada 89169 —
Research site Albany New York 12206 —
Research site Laurelton New York 11413 —
Research site New Windsor New York 12553 —
Research site New York New York 10036 —
Research site The Bronx New York 10468 —
Research site Morganton North Carolina 28655 —
Research site Marion Ohio 43302 —
Research site Oklahoma City Oklahoma 73112 —
Research site Lansdale Pennsylvania 19446 —
Research site Gaffney South Carolina 29340 —
Research site Summerville South Carolina 29485 —
Research site Union South Carolina 29379 —
Research site Georgetown Texas 78626 —
Research site Houston Texas 77043 —
Research site Houston Texas 77074 —
Research site Houston Texas 77079 —
Research site Kerrville Texas 78028 —
Research site Clinton Utah 84015 —
Research site Ogden Utah 84405 —
Research site Manassas Virginia 20110 —

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

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 15 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03361501, 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 Aug 12, 2020 · Synced Oct 20, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03361501 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →