HypertriglyceridemiaPhase 3TRILOGY 1NCT03398005
A Phase 3 STudy of CaPRe In LOwering Very hiGh TriglYcerides (TRILOGY 1)
A Phase 3 study testing CaPre in people with Hypertriglyceridemia, run by Grace Therapeutics Inc. at 69 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertriglyceridemia
- What is being tested?
- CaPre
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 256 participants
- Where
- 69 sitesUnited States
- Study dates
- 23 Jan 2018to 20 Nov 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 32Show fewer
- 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.
Trial locations and contacts
69 sites in 1 country.
69 sites in 1 country
United States69 sites
Research site
Anderson, Indiana, 46011
Research site
Arlington, Texas, 76012
Research site
Atlanta, Georgia, 30345
Research site
Beaver, Pennsylvania, 15009
Research site
Bellevue, Washington, 98007
Research site
Birmingham, Alabama, 35242
Research site
Boca Raton, Florida, 33487
Research site
Cadillac, Michigan, 49601
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Canton, Ohio, 44710
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Chattanooga, Tennessee, 37421
Research site
Clearwater, Florida, 33765
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Conway, Arkansas, 72034
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Danville, Virginia, 24541
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El Cajon, California, 92020
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Eunice, Louisiana, 70535
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Fort Myers, Florida, 33912
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Fresno, California, 93702
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Gainesville, Georgia, 30501
Research site
Garden Grove, California, 92844
Research site
Greensboro, North Carolina, 27408
Research site
Gurnee, Illinois, 60031
Research site
Hialeah, Florida, 33012
Research site
Homestead, Florida, 33030
Research site
Houston, Texas, 77084
Research site
Houston, Texas, 77089
Research site
Jackson, Mississippi, 39202
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Jacksonville, Florida, 32256
Research site
Kendall, Florida, 33175
Research site
Kenosha, Wisconsin, 53144
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Lake Worth, Florida, 33461
Research site
Lampasas, Texas, 76550
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Lomita, California, 90717
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Louisville, Kentucky, 40213
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Marion, Ohio, 43302
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Maumee, Ohio, 43537
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Memphis, Tennessee, 38119
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Meridian, Idaho, 83642
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Meridian, Idaho, 83646
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
Mooresville, North Carolina, 28117
Research site
Newport Beach, California, 92663
Research site
Norman, Oklahoma, 73069
Research site
North Miami Beach, Florida, 33162
Research site
Olive Branch, Mississippi, 38654
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Omaha, Nebraska, 68114
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Orlando, Florida, 32825
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Pembroke Pines, Florida, 33026
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Salt Lake City, Utah, 84107
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San Antonio, Texas, 78258
Research site
Savannah, Georgia, 31406
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Snellville, Georgia, 30078
Research site
Spartanburg, South Carolina, 29301
Research site
St Louis, Missouri, 63117
Research site
Sugar Hill, Georgia, 30518
Research site
Tamarac, Florida, 33321
Research site
Tampa, Florida, 33603
Research site
Tucson, Arizona, 85712
Research site
Tustin, California, 92780
Research site
Wellington, Florida, 33449
Research site
West Jordan, Utah, 84088
Research site
West Palm Beach, Florida, 33401
Research site
West Palm Beach, Florida, 33409
About this study
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.
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
- Being tested
- CaPre, Placebo
- Keywords
- Omega-3 Fatty acids, Triglycerides
- Medical subject headings
- Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaPreDrug
4 x 1 g capsules administered orally once a day for 26 weeks
PlaceboDrug
4 x 1 g capsules administered orally once a day for 26 weeks
| Study group | Role | What they receive |
|---|---|---|
| CaPre | Experimental | Not described Receives: Drug: CaPre |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Week 12
Percent change from baseline (Week -1 and 0) to Week 12 (average of Week 11 and 12) in VLDL-C (β-quantification).
Measured: 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.
Measured: 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).
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2018
- Study start23 Jan 2018
- Primary completion21 Jul 2019
- Study completion20 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertriglyceridemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grace Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dariush Mozaffarian, MD, DrPH, Principal investigator, Tufts Friedman School of Nutrition Science and Policy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03398005
- Sponsor's protocol ID
- ACA-CAP-001
- Acronym
- TRILOGY 1
- Status last verified
- Jan 2020
- First submitted
- 21 Nov 2017
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34989797
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03398005
- Acronym / sponsor ID
- TRILOGY 1 / ACA-CAP-001
- Conditions
- Hypertriglyceridemia
- Keywords
- Omega-3 Fatty acids, Triglycerides
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- Grace Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Jan 2018 (actual)
- Primary completion
- 21 Jul 2019 (actual)
- Study completion
- 20 Nov 2019 (actual)
- First posted
- 12 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CaPre | Experimental | Drug: CaPre |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (32 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CaPre4 x 1 g capsules administered orally once a day for 26 weeks | Drug | CaPre |
| Placebo4 x 1 g capsules administered orally once a day for 26 weeks | Drug | Placebo |
Primary outcome
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
4 secondary outcomes
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Derived from this study: PubMed 34989797Mozaffarian 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dariush Mozaffarian, MD, DrPH principal investigator
Tufts Friedman School of Nutrition Science and Policy
69 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CaPre in people with Hypertriglyceridemia, run by Grace Therapeutics Inc. at 69 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 69 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03398005, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.