The Efficacy and Safety of PRC-4016 in Hypertriglyceridemic Subjects

Phase 2

Completed

• Conditions: Dyslipidemia
• Interventions: Drug: PRC-4016; Drug: Placebo

• Registration Number: NCT01893515
• Lead Sponsor: Pronova BioPharma

Brief 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

Detailed Description

6-8 weeks screening period with diet/lifestyle stabilization and lipid qualification

Study Timeline

• Study First Submitted: 2013-06-28
• Study Start: 2013-07
• Study First Submitted QC: 2013-07-02
• Study First Posted: 2013-07-09
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Disposition First Submitted: 2015-09-21
• Disposition First Submitted QC: 2015-09-21
• Status Verified: 2015-10
• Disposition First Posted: 2015-10-07
• Last Update Submitted: 2015-10-07
• Last Update Posted: 2015-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PRC-4016	PRC-4016	PRC-4016, oral administration once daily, capsule
Placebo	Placebo	Placebo, oral administration once daily, capsule

Primary Outcome Measures

Name	Time	Method
Percent change in triglycerides from baseline to week 12	from baseline to Week 12

Secondary Outcome Measures

Name	Time	Method
Change in red blood cell content of EPA and DHA from baseline to Week 12;	from baseline to Week 12;
Change in HDL-C from baseline to Week 12	from baseline to Week 12
Change in non-HDL-C from baseline to Week 12	from baseline to Week 12
Change in LDL-C from baseline to Week 12	from baseline to week 12
Change in VLDL-C from baseline to Week 12	from baseline to week 12
Change in total cholesterol from baseline to Week 12	from baseline to week 12
Change in ApoA1 from baseline to Week 12	from baseline to Week 12
Change in Apo B from baseline to Week 12	from baseline to week 12
Change in insulin from baseline to Week 12	from baseline to Week 12
Change in fasting plasma glucose from baseline to Week 12	from baseline to Week 12
Change in HbA1c from baseline to Week 12	from baseline to Week 12
Change in insulin resistance (HOMA) from baseline to Week 12	from baseline to Week 12
Change in Lp-PLA2 from baseline to Week 12	from baseline to Week 12
Change in hsCRP from baseline to Week 12	from baseline to Week 12

Trial Locations

Locations (39)

Medical Affiliated Research Center, Inc.; 🇺🇸 Huntsville, Alabama, United States

Terence Hart, MD; 🇺🇸 Muscle Shoals, Alabama, United States

Central Phoenix Medical Clinic; 🇺🇸 Phoenix, Arizona, United States

Pacific Oaks Medical Group; 🇺🇸 Beverly Hills, California, United States

National Research Institute - Wilshire; 🇺🇸 Los Angeles, California, United States

National Research Institute - East 118; 🇺🇸 Los Angeles, California, United States

Research Across America - Santa Ana; 🇺🇸 Santa Ana, California, United States

Encompass Clinical Research; 🇺🇸 Spring Valley, California, United States

Colorado Springs Health Partners; 🇺🇸 Colorado Springs, Colorado, United States

Clinical Research of South Florida; 🇺🇸 Coral Gables, Florida, United States

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