- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02250105
Trial of ARI-3037MO to Reduce Triglyceride Levels in Adults With Severe (≥500 mg/dl) Hypertriglyceridemia
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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California
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Tustin, California, United States, 92780
- Orange County Research Center
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Kentucky
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Louisville, Kentucky, United States, 40213
- Louisville Metabolic and Atherosclerosis Research Center
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Maine
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Auburn, Maine, United States, 04210
- Maine Research Associates
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Ohio
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Cincinnati, Ohio, United States, 45219
- Sterling Clinical Research Inc
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Virginia
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Richmond, Virginia, United States, 23294
- National Clinical Research inc
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria 1. Age ≥ 18 years. 2. Subjects willing to comply with lifestyle intervention modifications (diet and exercise) 3. TG levels: At randomization, mean level > 500 mg/dL and < 2,000 mg/dL. 4. Understands the trial requirements and the treatment procedures, is willing to comply with all protocol-required follow-up evaluation and provides written informed consent.
5. Patients already taking statin therapy must be on a stable dose, defined as no changes in the dose of statin in the 3 months prior to enrollment, and must be willing and able to remain on that dose for the duration of the study.
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Exclusion Criteria 1. History of pancreatitis. 2. Body mass index > 45 kg/m2. 3. Weight change ≥ 3 kg during the lead-in period. 4. Contraindication to niacin treatment (prior flushing is not regarded as a contraindication to niacin treatment).
5. Uncontrolled diabetes, defined as HbA1C > 10.5. 6. Subjects who would benefit from statin treatment per clinical guidelines but who are not taking statins are excluded. However, these patients may be included only if the subject's primary care physician confirms the decision not to treat according to guidelines and its reason (e.g. statin intolerant subjects, subject refusal, etc.), and it has been agreed upon by the subject, the site investigator, and the primary care physician, after discussion of the potential risks of non-treatment with statins..
7. History of stroke, myocardial infarction, life-threatening arrhythmia, or coronary vascularization within 6 months before screening.
8. Thyroid-stimulating hormone ≥ 1.5 times the ULN. 9. Clinical evidence of hypothyroidism or thyroid hormonal therapy that has not been stable for ≥ 6 weeks before screening.
10. Creatine kinase concentration ≥ 3 times the ULN. 11. Known, active liver disease, including but not limited to:
- Confirmed alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, or bilirubin ≥ 2 times the ULN.
- Hepatitis C (anti-hepatitis C virus IgG +).
- Hepatitis B (hepatitis B surface [HBs] antigen +, anti hepatitis B core [HBc] antigen immunoglobulin M [IgM]+).
Hepatitis A (anti HBa IgM+). 12. Blood donation of ≥ 1 pint (0.5 L) within 30 days before screening or plasma donation within 7 days before screening.
13. History of symptomatic gallstone disease unless treated with cholecystectomy.
14. Known nephrotic syndrome or ≥ 3 g/day proteinuria. 15. Past organ transplant or on a waiting list for an organ transplant. 16. Currently receiving or scheduled to receive chemotherapy within 30 days before or after enrollment.
17. Other serious medical illness (e.g., cancer, congestive heart failure) with estimated life expectancy of less than 12 months.
18. Problems with substance abuse, which, in the opinion of the investigator, might affect study compliance.
19. Planned procedure that may cause non-compliance with the protocol or confound data interpretation.
20. Current participation in another investigational drug or device clinical trial that has not reached its primary endpoint.
21. Women who intend to become pregnant within 12 months after enrollment. Women of child-bearing potential who are sexually active must agree to use a reliable method of contraception from the time of screening through 12 months after enrollment.
22. Women who are pregnant or nursing. 23. Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: ARI-3037MO
ARI-3037MO 3g bid orally for 12 weeks
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Lipid lowering
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Placebo Comparator: Placebo
Matching placebo 3g bid orally for 12 weeks
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Inactive
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Triglyceride levels
Time Frame: 12 weeks
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in LDL cholesterol
Time Frame: 12 weeks
|
12 weeks
|
Change in HDL cholesterol
Time Frame: 12 weeks
|
12 weeks
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ARI-3037MO-004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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