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

Completed · Phase 3 · Has a placebo group

Conditions studied: Hypertriglyceridemia

In brief

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).

Key facts

Study ID

NCT03361501

Run by

Grace Therapeutics Inc.

People needed

278

Starts

2018-02-01

Expected to finish

2020-01-09

Last updated by the study team

2020-08-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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).
• 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 (including over-the-counter or supplemental agents); 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.

Where it is running

• Research site — Childersburg, Alabama, United States
• Research site — Encino, California, United States
• Research site — Long Beach, California, United States
• Research site — San Diego, California, United States
• Research site — Thousand Oaks, California, United States
• Research site — Torrance, California, United States
• Research site — Monument, Colorado, United States
• Research site — Clearwater, Florida, United States
• Research site — Coral Gables, Florida, United States
• Research site — DeLand, Florida, United States
• Research site — Fort Lauderdale, Florida, United States
• Research site — Jacksonville, Florida, United States
• Research site — Jacksonville, Florida, United States
• Research site — Miami, Florida, United States
• Research site — Miami, Florida, United States
• Research site — Miami, Florida, United States
• Research site — Miami Lakes, Florida, United States
• Research site — Dunwoody, Georgia, United States
• Research site — Peachtree Corners, Georgia, United States
• Research site — Savannah, Georgia, United States
• Research site — Boise, Idaho, United States
• Research site — Wauconda, Illinois, United States
• Research site — Iowa City, Iowa, United States
• Research site — Overland Park, Kansas, United States
• Research site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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