NCT02250105

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Arisaph Pharmaceuticals Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	ARI-3037MO	Lipid lowering
DRUG	Placebo	Inactive

Timeline

• Start date: 2014-09-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2014-09-26
• Last updated: 2016-08-08

Locations

5 sites across 1 country: United States