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

Phase 2

Completed

• Conditions: Hypertriglyceridemia
• Interventions: Drug: Placebo; Drug: ARI-3037MO

• Registration Number: NCT02250105
• Lead Sponsor: Arisaph Pharmaceuticals Inc

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-24
• Study First Submitted QC: 2014-09-24
• Study First Posted: 2014-09-26
• Status Verified: 2015-08
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Last Update Submitted: 2016-08-05
• Last Update Posted: 2016-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Matching placebo 3g bid orally for 12 weeks
ARI-3037MO	ARI-3037MO	ARI-3037MO 3g bid orally for 12 weeks

Primary Outcome Measures

Name	Time	Method
Change in Triglyceride levels	12 weeks

Secondary Outcome Measures

Name	Time	Method
Change in LDL cholesterol	12 weeks
Change in HDL cholesterol	12 weeks

Trial Locations

Locations (5)

National Clinical Research inc; 🇺🇸 Richmond, Virginia, United States

Louisville Metabolic and Atherosclerosis Research Center; 🇺🇸 Louisville, Kentucky, United States

Maine Research Associates; 🇺🇸 Auburn, Maine, United States

Orange County Research Center; 🇺🇸 Tustin, California, United States

Sterling Clinical Research Inc; 🇺🇸 Cincinnati, Ohio, United States