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

Primary Purpose

Hypertriglyceridemia

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
CaPre
Placebo
Sponsored by
Acasti Pharma Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertriglyceridemia focused on measuring Omega-3 Fatty acids, Triglycerides

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subjects ≥18 years of age.
  2. Isolated hypertriglyceridemia, with triglycerides ≥500 mg/dL and <1500 mg/dL (≥5.7 mmol/L and <17.0 mmol/L) OR Mixed hyperlipidemia, with serum triglycerides ≥500 and <1500 mg/dL treated with a statin, CAI or PCSK9I inhibitor, alone or in combination, that has been stable for 6 weeks prior to randomization. If the subject is not being treated and not contraindicated, a statin and/or CAI treatment may be initiated at the discretion of the Investigator at time of screening.
  3. Willingness to maintain current physical activity level and follow the NCEP-TLC diet throughout the study.
  4. Be informed of the nature of the study and give written consent prior to any study procedure.

Exclusion Criteria:

  1. Allergy or intolerance to OM3 fatty acids, OM3-acid ethyl esters, OM3 phospholipids, fish, shell fish, or any component of the study medication.
  2. Known lipoprotein lipase impairment or deficiency, or apo CII deficiency.
  3. Subjects with lysosomal acid lipase deficiency.
  4. Body mass index greater than 45 kg/m2.
  5. Subjects who are pregnant, lactating, and subjects of childbearing potential who are either planning to become pregnant or who are not using acceptable birth control methods during study participation. Subjects of childbearing potential are subjects who have experienced menarche and do not otherwise meet the criteria for subjects not of childbearing potential, defined as:

    • Subjects who have had surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation); or
    • Subjects who are postmenopausal, i.e., who have had a cessation of menses for at least 12 months without an alternative medical cause. A follicle stimulating hormone (FSH) test ≥40 mIU/mL may be used to confirm the post-menopausal state in women not using hormonal contraception or hormonal replacement therapy.

    Subjects of childbearing potential must test negative for pregnancy at the time of enrollment and agree to use an acceptable contraceptive method or remain abstinent during the study or for at least 8 weeks following the last dose of study medication, whichever is longer.

  6. Subjects taking tamoxifen, estrogens, or progestins, or other medications or nutritional supplements with mechanisms modifying estrogen or progestogen pathways, who have had dosage changes within 4 weeks prior to Visit 1.
  7. Use of oral or injected corticosteroids or anabolic steroids within 6 weeks prior to randomization.
  8. History of pancreatitis within the last 6 months prior to Visit 1.
  9. History of symptomatic gallstone disease within the last 5 years, unless treated with cholecystectomy.
  10. Diabetics requiring changes in medical therapy (other than short acting insulin dosage adjustments) within 6 weeks prior to Visit 1 or who have HbA1c greater than 9.5% at Visit 1.
  11. Clinical or biochemical evidence of hyperthyroidism not stable with medication for at least 6 weeks prior to Visit 1.
  12. Uncontrolled hypothyroidism or thyroid stimulating hormone (TSH) level more than 1.5 × upper limit of normal (ULN).
  13. Thyroid hormone replacement therapy that has not been stable for more than 6 weeks prior to Visit 1.
  14. History of cancer (other than basal cell carcinoma) within 2 years prior to Visit 1.
  15. Cardiovascular event (i.e., myocardial infarction, acute coronary syndrome, new onset angina, stroke, transient ischemic attack, exacerbation of congestive heart failure requiring hospitalization or a change in treatment), life threatening arrhythmia, or revascularization procedure within 6 months prior to Visit 1.
  16. Use of other prohibited drugs: weight loss prescription medications; human immunodeficiency virus (HIV) protease inhibitors; cyclophosphamide; isotretinoin; routine or anticipated use of systemic corticosteroids (local, topical, inhalation, or nasal corticosteroids are permitted); or anabolic steroids.
  17. Use of any lipid-altering drug therapy, other than statins, CAI (such as ezetimibe) or PCSK9I inhibitors, alone or in combination, including niacin at a dose greater than 200 mg/day, fibrates, bile acid sequestrants, OM3 drugs (e.g., Lovaza or its generics,Vascepa, Epanova, Omtryg), OM3 supplements (e.g., fish oil, krill oil products), or any other herbal products or dietary supplements with potential lipid-altering effects. These products must be discontinued at least 6 weeks prior to randomization.
  18. Resection of an aortic aneurysm or endovascular aortic repair within 6 months prior to Visit 1.
  19. Recent history (within 6 months prior to Visit 1) or current significant nephrotic syndrome or ≥3 gram proteinuria daily, pulmonary, gastrointestinal, or immunologic disease.
  20. Poorly controlled hypertension (systolic blood pressure ≥170 mmHg and/or diastolic blood pressure ≥100 mmHg). Subjects with hypertension adequately controlled with medication are eligible provided that their antihypertensive therapy has been stable for at least 4 weeks prior to Visit 1.
  21. Recent history (past 12 months) of drug abuse or alcohol abuse, or alcohol use greater than 2 units per day (a unit of alcohol is defined as a 12-ounce (350 mL) beer, 5 ounce (150 mL) wine, or 1.5-ounce (45 mL) of 80-proof alcohol for drinks).
  22. Hepatobiliary disease or serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >5× ULN; if ALT/AST is >3× ULN, the levels must have been stable for 3 months prior to Visit 1.
  23. Severe renal disease as defined by less than 30 mL/min serum creatinine clearance calculated using the Cockcroft-Gault formula.
  24. Significant coagulopathy as defined by a known hereditary deficiency of coagulation factors or platelet function or an unexplained elevation of the prothrombin time (PT) international normalized ratio (INR) of ≥1.5. Subjects using warfarin [Coumadin®] or heparin are allowed. Subjects receiving other anticoagulants dabigatran, rivaroxaban, or apixaban are allowed. Subjects receiving acetylsalicylic acid (ASA) alone or in combination with other anti platelet agents (e.g., clopidogrel, prasugrel, ticagrelor) are also allowed.
  25. Unexplained creatine kinase concentration 3 × ULN.
  26. Creatine kinase elevation owing to known hereditary or acquired muscle disease.
  27. Exposure to any investigational product, within 4 weeks prior to Visit 1.
  28. Presence of any other condition the Investigator believes would interfere with the subject's ability to provide informed consent, comply with study instructions, or which might confound the interpretation of the study results or put the subject at undue risk.
  29. Any life-threatening disease expected to result in death within 2 years, require frequent hospitalizations, extensive surgery or changes in medications or diet.

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

CaPre

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Percent change in fasting TG levels from baseline (average of Week -2, -1, and 0) to Week 12 (average of Week 11 and 12) in patients with fasting TG levels ≥500 mg/dL and ≤1500 mg/dL (≥5.7 mmol/L and ≤17.0 mmol/L).

Secondary Outcome Measures

Percent change from baseline (average of Week -2, -1, and 0) to Week 12 (average of Week 11 and 12) in non-HDL-C.
Percent change from baseline (Week -1 and 0) to Week 12 (average of Week 11 and 12) in VLDL-C (β-quantification).
Percent change from baseline (average of Week -2, -1, and 0) to Week 12 (average of Week 11 and 12) in HDL-C.
Percent change from baseline (average of Week -1 and 0) to Week 12 (average of Week 11 and 12) in LDL-C (β-quantification).

Full Information

First Posted
November 21, 2017
Last Updated
January 14, 2020
Sponsor
Acasti Pharma Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03398005
Brief Title
A Phase 3 STudy of CaPRe In LOwering Very hiGh TriglYcerides (TRILOGY 1)
Acronym
TRILOGY 1
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.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
January 23, 2018 (Actual)
Primary Completion Date
July 21, 2019 (Actual)
Study Completion Date
November 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Acasti Pharma Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertriglyceridemia
Keywords
Omega-3 Fatty acids, Triglycerides

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
256 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CaPre
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
CaPre
Intervention Description
4 x 1 g capsules administered orally once a day for 26 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
4 x 1 g capsules administered orally once a day for 26 weeks
Primary Outcome Measure Information:
Title
Percent change in fasting TG levels from baseline (average of Week -2, -1, and 0) to Week 12 (average of Week 11 and 12) in patients with fasting TG levels ≥500 mg/dL and ≤1500 mg/dL (≥5.7 mmol/L and ≤17.0 mmol/L).
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Percent change from baseline (average of Week -2, -1, and 0) to Week 12 (average of Week 11 and 12) in non-HDL-C.
Time Frame
Week 12
Title
Percent change from baseline (Week -1 and 0) to Week 12 (average of Week 11 and 12) in VLDL-C (β-quantification).
Time Frame
Week 12
Title
Percent change from baseline (average of Week -2, -1, and 0) to Week 12 (average of Week 11 and 12) in HDL-C.
Time Frame
Week 12
Title
Percent change from baseline (average of Week -1 and 0) to Week 12 (average of Week 11 and 12) in LDL-C (β-quantification).
Time Frame
Week 12
Other Pre-specified Outcome Measures:
Title
Percent change from baseline (average of Week -2, -1, and 0) to all measured visits other than Week 12 (Week 4, Week 18 and Week 26) in TG (persistence of the effect of CaPre on TG).
Time Frame
Week 4; Week 18; Week 24
Title
Proportion of subjects with a fasting TG level below 500 mg/dL (<5.7 mmol/L) at Week 12 and at Week 26.
Time Frame
Week 12; Week 26
Title
Percent change from baseline (average of Week -2, -1, and 0) to Week 12 (average of Week 11 and Week 12) and Week 26 in TC.
Time Frame
Week 12; Week 26
Title
Percent change from baseline (average of Week -1 and 0) to Week 12 (average of Week 11 and 12) and to Week 26 in RLP-C.
Time Frame
Week 12; Week 26
Title
Percent change from baseline (average of Week -1 and 0) to Week 26 in LDL-C (β-quantification) and VLDL-C (β-quantification).
Time Frame
Week 26
Title
Percent change from baseline (average of Week -2, -1, and 0) to Week 26 in non-HDL-C and HDL-C.
Time Frame
Week 26
Title
Percent change from baseline (Week 0) to Week 12 and to Week 26 in apo B, apo A1, apo B/apo A1 ratio, apo CIII and apo A5.
Time Frame
Week 12; Week 26
Title
Percent change from baseline (Week 0) to Week 12 and to Week 26 in lipoprotein particles concentration and size (LDL, non-HDL, HDL, IDL and VLDL).
Time Frame
Week 12; Week 26
Title
Percent change from baseline (Week 0) to Week 12 and to Week 26 in oxidized LDL.
Time Frame
Week 12; Week 26
Title
Percent change from baseline (Week 0) to Week 12 and to Week 26 in fasting serum glucose, insulin and HbA1c.
Time Frame
Week 12; Week 26
Title
Percent change from baseline (Week 0) to Week 12 and to Week 26 in HOMA-IR and HOMA-β.
Time Frame
Week 12; Week 26
Title
Percent change from baseline (Week 0) to Week 12 and to Week 26 in hs-CRP and Lp-PLA2.
Time Frame
Week 12; Week 26
Title
Change from baseline (Week 0) to Week 4, Week 12, Week 18 and to Week 26 in Total plasma EPA concentration and Total plasma DHA concentration.
Time Frame
Week 4; Week 12; Week 18; Week 26
Title
Percent change from baseline (Week 0) to Week 4, Week 12, Week 18 and to Week 26 in Total plasma EPA concentration and Total plasma DHA concentration.
Time Frame
Week 4; Week 12; Week 18; Week 26
Title
Change from baseline (Week 0) to Week 12 and to Week 26 in OM3 Index.
Time Frame
Week 12; Week 26
Title
Percent change from baseline (Week 0) to Week 12 and to Week 26 in OM3 Index.
Time Frame
Week 12; Week 26
Title
Change from baseline (Week 0) to Week 12 and to Week 26 in AA.
Time Frame
Week 12; Week 26
Title
Percent change from baseline (Week 0) to Week 12 and to Week 26 in AA.
Time Frame
Week 12; Week 26
Title
Change from baseline (Week 0) to Week 12 and to Week 26 in omega-6/omega-3 ratio.
Time Frame
Week 12; Week 26
Title
Percent change from baseline (Week 0) to Week 12 and to Week 26 in omega-6/omega-3 ratio.
Time Frame
Week 12; Week 26
Title
Change from baseline (Week 0) to Week 12 and to Week 26 in EPA/AA ratio.
Time Frame
Week 12; Week 26
Title
Percent change from baseline (Week 0) to Week 12 and to Week 26 in EPA/AA ratio.
Time Frame
Week 12; Week 26

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects ≥18 years of age. Isolated hypertriglyceridemia, with triglycerides ≥500 mg/dL and <1500 mg/dL (≥5.7 mmol/L and <17.0 mmol/L) OR Mixed hyperlipidemia, with serum triglycerides ≥500 and <1500 mg/dL treated with a statin, CAI or PCSK9I inhibitor, alone or in combination, that has been stable for 6 weeks prior to randomization. If the subject is not being treated and not contraindicated, a statin and/or CAI treatment may be initiated at the discretion of the Investigator at time of screening. Willingness to maintain current physical activity level and follow the NCEP-TLC diet throughout the study. Be informed of the nature of the study and give written consent prior to any study procedure. Exclusion Criteria: Allergy or intolerance to OM3 fatty acids, OM3-acid ethyl esters, OM3 phospholipids, fish, shell fish, or any component of the study medication. Known lipoprotein lipase impairment or deficiency, or apo CII deficiency. Subjects with lysosomal acid lipase deficiency. Body mass index greater than 45 kg/m2. Subjects who are pregnant, lactating, and subjects of childbearing potential who are either planning to become pregnant or who are not using acceptable birth control methods during study participation. Subjects of childbearing potential are subjects who have experienced menarche and do not otherwise meet the criteria for subjects not of childbearing potential, defined as: Subjects who have had surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation); or Subjects who are postmenopausal, i.e., who have had a cessation of menses for at least 12 months without an alternative medical cause. A follicle stimulating hormone (FSH) test ≥40 mIU/mL may be used to confirm the post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. Subjects of childbearing potential must test negative for pregnancy at the time of enrollment and agree to use an acceptable contraceptive method or remain abstinent during the study or for at least 8 weeks following the last dose of study medication, whichever is longer. Subjects taking tamoxifen, estrogens, or progestins, or other medications or nutritional supplements with mechanisms modifying estrogen or progestogen pathways, who have had dosage changes within 4 weeks prior to Visit 1. Use of oral or injected corticosteroids or anabolic steroids within 6 weeks prior to randomization. History of pancreatitis within the last 6 months prior to Visit 1. History of symptomatic gallstone disease within the last 5 years, unless treated with cholecystectomy. Diabetics requiring changes in medical therapy (other than short acting insulin dosage adjustments) within 6 weeks prior to Visit 1 or who have HbA1c greater than 9.5% at Visit 1. Clinical or biochemical evidence of hyperthyroidism not stable with medication for at least 6 weeks prior to Visit 1. Uncontrolled hypothyroidism or thyroid stimulating hormone (TSH) level more than 1.5 × upper limit of normal (ULN). Thyroid hormone replacement therapy that has not been stable for more than 6 weeks prior to Visit 1. History of cancer (other than basal cell carcinoma) within 2 years prior to Visit 1. Cardiovascular event (i.e., myocardial infarction, acute coronary syndrome, new onset angina, stroke, transient ischemic attack, exacerbation of congestive heart failure requiring hospitalization or a change in treatment), life threatening arrhythmia, or revascularization procedure within 6 months prior to Visit 1. Use of other prohibited drugs: weight loss prescription medications; human immunodeficiency virus (HIV) protease inhibitors; cyclophosphamide; isotretinoin; routine or anticipated use of systemic corticosteroids (local, topical, inhalation, or nasal corticosteroids are permitted); or anabolic steroids. Use of any lipid-altering drug therapy, other than statins, CAI (such as ezetimibe) or PCSK9I inhibitors, alone or in combination, including niacin at a dose greater than 200 mg/day, fibrates, bile acid sequestrants, OM3 drugs (e.g., Lovaza or its generics,Vascepa, Epanova, Omtryg), OM3 supplements (e.g., fish oil, krill oil products), or any other herbal products or dietary supplements with potential lipid-altering effects. These products must be discontinued at least 6 weeks prior to randomization. Resection of an aortic aneurysm or endovascular aortic repair within 6 months prior to Visit 1. Recent history (within 6 months prior to Visit 1) or current significant nephrotic syndrome or ≥3 gram proteinuria daily, pulmonary, gastrointestinal, or immunologic disease. Poorly controlled hypertension (systolic blood pressure ≥170 mmHg and/or diastolic blood pressure ≥100 mmHg). Subjects with hypertension adequately controlled with medication are eligible provided that their antihypertensive therapy has been stable for at least 4 weeks prior to Visit 1. Recent history (past 12 months) of drug abuse or alcohol abuse, or alcohol use greater than 2 units per day (a unit of alcohol is defined as a 12-ounce (350 mL) beer, 5 ounce (150 mL) wine, or 1.5-ounce (45 mL) of 80-proof alcohol for drinks). Hepatobiliary disease or serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >5× ULN; if ALT/AST is >3× ULN, the levels must have been stable for 3 months prior to Visit 1. Severe renal disease as defined by less than 30 mL/min serum creatinine clearance calculated using the Cockcroft-Gault formula. Significant coagulopathy as defined by a known hereditary deficiency of coagulation factors or platelet function or an unexplained elevation of the prothrombin time (PT) international normalized ratio (INR) of ≥1.5. Subjects using warfarin [Coumadin®] or heparin are allowed. Subjects receiving other anticoagulants dabigatran, rivaroxaban, or apixaban are allowed. Subjects receiving acetylsalicylic acid (ASA) alone or in combination with other anti platelet agents (e.g., clopidogrel, prasugrel, ticagrelor) are also allowed. Unexplained creatine kinase concentration 3 × ULN. Creatine kinase elevation owing to known hereditary or acquired muscle disease. Exposure to any investigational product, within 4 weeks prior to Visit 1. Presence of any other condition the Investigator believes would interfere with the subject's ability to provide informed consent, comply with study instructions, or which might confound the interpretation of the study results or put the subject at undue risk. Any life-threatening disease expected to result in death within 2 years, require frequent hospitalizations, extensive surgery or changes in medications or diet.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dariush Mozaffarian, MD, DrPH
Organizational Affiliation
Tufts Friedman School of Nutrition Science and Policy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35242
Country
United States
Facility Name
Research site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Research site
City
Conway
State/Province
Arkansas
ZIP/Postal Code
72034
Country
United States
Facility Name
Research site
City
El Cajon
State/Province
California
ZIP/Postal Code
92020
Country
United States
Facility Name
Research site
City
Fresno
State/Province
California
ZIP/Postal Code
93702
Country
United States
Facility Name
Research site
City
Garden Grove
State/Province
California
ZIP/Postal Code
92844
Country
United States
Facility Name
Research site
City
Lomita
State/Province
California
ZIP/Postal Code
90717
Country
United States
Facility Name
Research site
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Research site
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
Research site
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33487
Country
United States
Facility Name
Research site
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Research site
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Research site
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Research site
City
Homestead
State/Province
Florida
ZIP/Postal Code
33030
Country
United States
Facility Name
Research site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Research site
City
Kendall
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
Research site
City
Lake Worth
State/Province
Florida
ZIP/Postal Code
33461
Country
United States
Facility Name
Research site
City
Miami Springs
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
Research site
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
Research site
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Research site
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Facility Name
Research site
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Research site
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Research site
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Facility Name
Research site
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Research site
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33162
Country
United States
Facility Name
Research site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32825
Country
United States
Facility Name
Research site
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33026
Country
United States
Facility Name
Research site
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Facility Name
Research site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
Research site
City
Wellington
State/Province
Florida
ZIP/Postal Code
33449
Country
United States
Facility Name
Research site
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Research site
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Research site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30345
Country
United States
Facility Name
Research site
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
Research site
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
Research site
City
Snellville
State/Province
Georgia
ZIP/Postal Code
30078
Country
United States
Facility Name
Research site
City
Sugar Hill
State/Province
Georgia
ZIP/Postal Code
30518
Country
United States
Facility Name
Research site
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Research site
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83646
Country
United States
Facility Name
Research site
City
Gurnee
State/Province
Illinois
ZIP/Postal Code
60031
Country
United States
Facility Name
Research site
City
Anderson
State/Province
Indiana
ZIP/Postal Code
46011
Country
United States
Facility Name
Research site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40213
Country
United States
Facility Name
Research site
City
Eunice
State/Province
Louisiana
ZIP/Postal Code
70535
Country
United States
Facility Name
Research site
City
Cadillac
State/Province
Michigan
ZIP/Postal Code
49601
Country
United States
Facility Name
Research site
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Facility Name
Research site
City
Olive Branch
State/Province
Mississippi
ZIP/Postal Code
38654
Country
United States
Facility Name
Research site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
Facility Name
Research site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Research site
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
Facility Name
Research site
City
Mooresville
State/Province
North Carolina
ZIP/Postal Code
28117
Country
United States
Facility Name
Research site
City
Canton
State/Province
Ohio
ZIP/Postal Code
44710
Country
United States
Facility Name
Research site
City
Marion
State/Province
Ohio
ZIP/Postal Code
43302
Country
United States
Facility Name
Research site
City
Maumee
State/Province
Ohio
ZIP/Postal Code
43537
Country
United States
Facility Name
Research site
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73069
Country
United States
Facility Name
Research site
City
Beaver
State/Province
Pennsylvania
ZIP/Postal Code
15009
Country
United States
Facility Name
Research site
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29301
Country
United States
Facility Name
Research site
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
Research site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Research site
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Research site
City
Houston
State/Province
Texas
ZIP/Postal Code
77084
Country
United States
Facility Name
Research site
City
Houston
State/Province
Texas
ZIP/Postal Code
77089
Country
United States
Facility Name
Research site
City
Lampasas
State/Province
Texas
ZIP/Postal Code
76550
Country
United States
Facility Name
Research site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Facility Name
Research site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Research site
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
Research site
City
Danville
State/Province
Virginia
ZIP/Postal Code
24541
Country
United States
Facility Name
Research site
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Facility Name
Research site
City
Kenosha
State/Province
Wisconsin
ZIP/Postal Code
53144
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34989797
Citation
Mozaffarian D, Maki KC, Bays HE, Aguilera F, Gould G, Hegele RA, Moriarty PM, Robinson JG, Shi P, Tur JF, Lapointe JF, Aziz S, Lemieux P; TRILOGY (Study of CaPre in Lowering Very High Triglycerides) investigators. Effectiveness of a Novel omega-3 Krill Oil Agent in Patients With Severe Hypertriglyceridemia: A Randomized Clinical Trial. JAMA Netw Open. 2022 Jan 4;5(1):e2141898. doi: 10.1001/jamanetworkopen.2021.41898.
Results Reference
derived

Learn more about this trial

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

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