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

NCT03398005 | Completed Phase 3 FDA Drug

• 1 other identifier: ACA-CAP-001
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 69

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).

Conditions

Hypertriglyceridemia

Keywords

Omega-3 Fatty acids; Triglycerides

Outcome Measures

Primary Outcomes (1)

• 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).

  Week 12

Secondary Outcomes (4)

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

  Week 12

• Percent change from baseline (Week -1 and 0) to Week 12 (average of Week 11 and 12) in VLDL-C (β-quantification).

  Week 12

• Percent change from baseline (average of Week -2, -1, and 0) to Week 12 (average of Week 11 and 12) in HDL-C.

  Week 12

• Percent change from baseline (average of Week -1 and 0) to Week 12 (average of Week 11 and 12) in LDL-C (β-quantification).

  Week 12

Other Outcomes (22)

• 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).

  Week 4; Week 18; Week 24

• Proportion of subjects with a fasting TG level below 500 mg/dL (<5.7 mmol/L) at Week 12 and at Week 26.

  Week 12; Week 26

• 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.

  Week 12; Week 26

Study Arms (2)

CaPre

EXPERIMENTAL

Drug: CaPre

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

CaPre DRUG

4 x 1 g capsules administered orally once a day for 26 weeks

CaPre

Placebo DRUG

4 x 1 g capsules administered orally once a day for 26 weeks

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Grace Therapeutics Inc.: lead

Study Sites (69)

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Birmingham, Alabama, 35242, United States

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Tucson, Arizona, 85712, United States

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Conway, Arkansas, 72034, United States

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El Cajon, California, 92020, United States

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Fresno, California, 93702, United States

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Garden Grove, California, 92844, United States

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Lomita, California, 90717, United States

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Newport Beach, California, 92663, United States

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Tustin, California, 92780, United States

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Boca Raton, Florida, 33487, United States

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Clearwater, Florida, 33765, United States

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Fort Myers, Florida, 33912, United States

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Hialeah, Florida, 33012, United States

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Homestead, Florida, 33030, United States

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Jacksonville, Florida, 32256, United States

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Kendall, Florida, 33175, United States

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Lake Worth, Florida, 33461, United States

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Miami, Florida, 33125, United States

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Miami, Florida, 33126, United States

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Miami, Florida, 33135, United States

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Miami, Florida, 33144, United States

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Miami, Florida, 33155, United States

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Miami, Florida, 33165, United States

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Miami, Florida, 33173, United States

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Miami Springs, Florida, 33166, United States

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North Miami Beach, Florida, 33162, United States

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Orlando, Florida, 32825, United States

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Pembroke Pines, Florida, 33026, United States

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Tamarac, Florida, 33321, United States

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Tampa, Florida, 33603, United States

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Wellington, Florida, 33449, United States

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West Palm Beach, Florida, 33401, United States

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West Palm Beach, Florida, 33409, United States

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Atlanta, Georgia, 30345, United States

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Gainesville, Georgia, 30501, United States

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Savannah, Georgia, 31406, United States

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Snellville, Georgia, 30078, United States

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Sugar Hill, Georgia, 30518, United States

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Meridian, Idaho, 83642, United States

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Meridian, Idaho, 83646, United States

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Gurnee, Illinois, 60031, United States

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Anderson, Indiana, 46011, United States

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Louisville, Kentucky, 40213, United States

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Eunice, Louisiana, 70535, United States

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Cadillac, Michigan, 49601, United States

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Jackson, Mississippi, 39202, United States

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Olive Branch, Mississippi, 38654, United States

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St Louis, Missouri, 63117, United States

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Omaha, Nebraska, 68114, United States

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Greensboro, North Carolina, 27408, United States

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Mooresville, North Carolina, 28117, United States

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Canton, Ohio, 44710, United States

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Marion, Ohio, 43302, United States

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Maumee, Ohio, 43537, United States

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Norman, Oklahoma, 73069, United States

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Beaver, Pennsylvania, 15009, United States

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Spartanburg, South Carolina, 29301, United States

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Chattanooga, Tennessee, 37421, United States

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Memphis, Tennessee, 38119, United States

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Arlington, Texas, 76012, United States

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Houston, Texas, 77084, United States

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Houston, Texas, 77089, United States

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Lampasas, Texas, 76550, United States

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San Antonio, Texas, 78258, United States

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Salt Lake City, Utah, 84107, United States

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West Jordan, Utah, 84088, United States

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Danville, Virginia, 24541, United States

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Bellevue, Washington, 98007, United States

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Kenosha, Wisconsin, 53144, United States

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Related Publications (1)

• 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.

  PMID: 34989797 DERIVED

MeSH Terms

Conditions

Hypertriglyceridemia

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Dariush Mozaffarian, MD, DrPH

  Tufts Friedman School of Nutrition Science and Policy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2017
• First Posted: January 12, 2018
• Study Start: January 23, 2018
• Primary Completion: July 21, 2019
• Study Completion: November 20, 2019
• Last Updated: January 18, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (69)