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

NCT02250105 | Completed Phase 2

• 1 other identifier: ARI-3037MO-004
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Hypertriglyceridemia

Outcome Measures

Primary Outcomes (1)

• Change in Triglyceride levels

  12 weeks

Secondary Outcomes (2)

• Change in LDL cholesterol

  12 weeks

• Change in HDL cholesterol

  12 weeks

Study Arms (2)

ARI-3037MO

ACTIVE COMPARATOR

ARI-3037MO 3g bid orally for 12 weeks

Drug: ARI-3037MO

Placebo

PLACEBO COMPARATOR

Matching placebo 3g bid orally for 12 weeks

Drug: Placebo

Interventions

ARI-3037MO DRUG

Lipid lowering

ARI-3037MO

Placebo DRUG

Inactive

Placebo

Eligibility Criteria

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

You may qualify if:

• \. 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.

You may not qualify if:

• \. 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..
• \. History of stroke, myocardial infarction, life-threatening arrhythmia, or coronary vascularization within 6 months before screening.
• \. 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.
• \. 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.
• \. History of symptomatic gallstone disease unless treated with cholecystectomy.
• \. 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.
• \. Other serious medical illness (e.g., cancer, congestive heart failure) with estimated life expectancy of less than 12 months.
• \. Problems with substance abuse, which, in the opinion of the investigator, might affect study compliance.
• \. Planned procedure that may cause non-compliance with the protocol or confound data interpretation.
• \. Current participation in another investigational drug or device clinical trial that has not reached its primary endpoint.
• \. 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.

Sponsors & Collaborators

• Arisaph Pharmaceuticals Inc: lead
• Baim Institute for Clinical Research: collaborator

Study Sites (5)

Orange County Research Center

Tustin, California, 92780, United States

Location

Louisville Metabolic and Atherosclerosis Research Center

Louisville, Kentucky, 40213, United States

Location

Maine Research Associates

Auburn, Maine, 04210, United States

Location

Sterling Clinical Research Inc

Cincinnati, Ohio, 45219, United States

Location

National Clinical Research inc

Richmond, Virginia, 23294, United States

Location

MeSH Terms

Conditions

Hypertriglyceridemia

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2014
• First Posted: September 26, 2014
• Study Start: September 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: August 8, 2016

Record last verified: 2015-08

Locations

US (5)