The Efficacy and Safety of PRC-4016 in Hypertriglyceridemic Subjects

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The objectives of this study is

• To evaluate the efficacy of PRC-4016 by assessment of the percentage change in blood lipids and lipoprotein parameters from baseline after 12 weeks of treatment.

• To evaluate the safety of PRC-4016 as assessed by adverse events and other safety parameters

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pronova BioPharma

Criteria

Main Inclusion Criteria:

• Fasting triglycerides 500-1500 mg/dl

• Not on other lipid altering therapy, OR on stable lipid altering therapy

Main Exclusion Criteria:

• Type I diabetes or uncontrolled type II diabetes

• Recent cardiovascular or coronary event

• History of pancreatitis

• History or evidence of major and clinically significant diseases that would interfere with the conduct of the study or interpretation of data

• Uncontrolled hypertension