NCT02532218

Evaluation of ARI-3037MO, to Suppress LDL Cholesterol in Patients With Dyslipidemia

Randomized Evaluation of ARI-3037MO, to Suppress LDL Cholesterol in Patients With Dyslipidemia

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 176 (estimated)
• Sponsor: Arisaph Pharmaceuticals Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the efficacy and safety of ARI-3037MO compared to placebo in reducing low-density lipoprotein cholesterol (LDL-C) levels in subjects with dyslipidemia.

Detailed description

This study is a prospective, multi-center, randomized, double-blinded, controlled clinical trial. The study will compare two arms: ARI-3037MO 3 g BID vs. placebo. Subjects who sign informed consent will be enrolled and will undergo all Visit 1 assessments. Following evaluation of Visit 1 laboratory assays, eligible subjects will receive a phone call (Visit 2) during which they will be instructed to begin the lifestyle modification and enter a 4- to 6-week lead-in period (6-week wash-out period for subjects to wash out of non-statin lipid-lowering therapy \[subjects may remain on statins during this period\], 4 weeks for subjects receiving statins only or not receiving any lipid-lowering therapy), followed by a qualifying fasting LDL-C measurement at Visit 3. After the lead-in period, if the LDL-C level at Visit 3 is not ≥ 100 mg/dL, an additional week will be allowed for another qualifying measurement at a subsequent visit (Visit 3.1). If performed, the LDL-C level at Visit 3.1 must be ≥ 100 mg/dL in order for the subject to continue participation in the study. Qualifying subjects will be randomized in a 1:1 manner at Visit 4 to one of two arms of the double-blind, 24-week efficacy and safety assessment phase. Randomization will be stratified by background statin therapy status at Visit 1 (yes/no). Baseline lipid levels will be defined as lipid levels at Visit 4. End-of-study lipid levels will be defined as the lipid levels at Visit 7 (Week 24). A final closeout and safety assessment visit will be held at 26 weeks post randomization (Visit 8).

Conditions

• Hyperlipidemia

Interventions

Type	Name	Description
DRUG	ARI-3037MO	Lipid lowering treatment Statins

Timeline

• Start date: 2015-08-01
• Primary completion: 2016-09-01
• Completion: 2016-12-01
• First posted: 2015-08-25
• Last updated: 2016-08-08

Locations

19 sites across 1 country: United States