Trial of ARI-3037MO to Reduce Triglyceride Levels in Adults With Severe (≥500 mg/dl) Hypertriglyceridemia

August 5, 2016 updated by: Arisaph Pharmaceuticals Inc
This study is to evaluate the efficacy and safety of ARI-3037MO 3g BID compared to placebo in reducing triglyceride (TG) levels of subjects with severe (≥500 mg/dL and <2,000 mg/dL) hypertriglyceridemia. Eligible patients will enter a 4- to 6-week lead-in period (6-week washout for subjects on non-statin lipid-lowering therapy [subjects may remain on statins during this period], 4 weeks for patients on statins only or not receiving any type of lipid-lowering therapy), followed by qualifying fasting TG measurements at visits 2 and 3, at least 7 days apart. If the baseline TG value is > 500 mg/dL and < 2,000 mg/dL, the qualified subjects will be randomized at visit 4 and enter the double-blind, 12-week efficacy and safety assessment phase. End-of-study lipid levels will be assessed on visits 6 and 7 (weeks 11 and 12 average). A final closeout and safety assessment visit will be done 14 weeks post randomization

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Tustin, California, United States, 92780
        • Orange County Research Center
    • Kentucky
      • Louisville, Kentucky, United States, 40213
        • Louisville Metabolic and Atherosclerosis Research Center
    • Maine
      • Auburn, Maine, United States, 04210
        • Maine Research Associates
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Sterling Clinical Research Inc
    • Virginia
      • Richmond, Virginia, United States, 23294
        • National Clinical Research inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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:

  1. Confirmed alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, or bilirubin ≥ 2 times the ULN.
  2. Hepatitis C (anti-hepatitis C virus IgG +).
  3. Hepatitis B (hepatitis B surface [HBs] antigen +, anti hepatitis B core [HBc] antigen immunoglobulin M [IgM]+).
  4. 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Active Comparator: ARI-3037MO
ARI-3037MO 3g bid orally for 12 weeks
Lipid lowering
Placebo Comparator: Placebo
Matching placebo 3g bid orally for 12 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

September 24, 2014

First Submitted That Met QC Criteria

September 24, 2014

First Posted (Estimate)

September 26, 2014

Study Record Updates

Last Update Posted (Estimate)

August 8, 2016

Last Update Submitted That Met QC Criteria

August 5, 2016

Last Verified

August 1, 2015

More Information

Terms related to this study

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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