Efficacy and Safety of PRC-4016 in Subjects With Mixed Dyslipidemia

A Multicenter, Randomized, Double-Blind, Placebo-Controlled 12-Week Phase II Proof of Concept Study to Evaluate the Efficacy and Safety of PRC-4016 600 mg Once Daily Versus Placebo in Statin-Stable Subjects With Mixed Dyslipidemia

The objective of this study is

• To evaluate the efficacy of PRC-4016 by assessment of the percentage change in blood lipids and lipoprotein parameter from baseline after 12 weeks of treatment
• To evaluate the safety of PRC-4016 as assessed by adverse events and other safety parameters

Study Overview

• Status: Terminated
• Conditions: Dyslipidemia
• Intervention / Treatment: Drug: Placebo; Drug: PRC-4016; Drug: Statins

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 113
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801
      • Medical Affiliated Research Center, Inc.
    • Muscle Shoals, Alabama, United States, 35662
      • Terence Hart, MD
  • California
    • Beverly Hills, California, United States, 90211
      • Pacific Oaks Medical Group
    • Los Angeles, California, United States, 90057
      • National Research Institute - Wilshire
    • Santa Ana, California, United States, 92705
      • Research Across America - Santa Ana
    • Spring Valley, California, United States, 91978
      • Encompass Clinical Research
  • Florida
    • Jacksonville, Florida, United States, 32223
      • Jacksonville Impotence Treatment Center
    • Oviedo, Florida, United States, 32765
      • Compass Research East, LLC
    • Port Orange, Florida, United States, 32127
      • Progressive Medical Research
    • St. Petersburg, Florida, United States, 33709
      • Meridien Research
    • Tampa, Florida, United States, 33606
      • Meridien Research- Tampa
  • Illinois
    • Evanston, Illinois, United States, 60201
      • Evanston Premier Healthcare Research LLC
  • Indiana
    • Evansville, Indiana, United States, 47714
      • Medisphere Medical Research Center
  • Kansas
    • Newton, Kansas, United States, 67114
      • Heartland Research Assoc., LLC
  • Kentucky
    • Louisville, Kentucky, United States, 40213
      • Louisville Metabolic and Atherosclerosis Research Center (L-MARC)
  • Michigan
    • Troy, Michigan, United States, 48098
      • Troy Internal Medicine, P.C.
  • Minnesota
    • Edina, Minnesota, United States, 55435
      • Radiant Research - Edina
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • Peters Medical Research
    • Raleigh, North Carolina, United States, 27609
      • PMG Research of Raleigh, LLC
  • Ohio
    • Cincinnati, Ohio, United States, 45227
      • Metabolic and Atherosclerosis Research Center
    • Cincinnati, Ohio, United States, 45219
      • Sterling Research Group, Ltd. - Auburn
    • Columbus, Ohio, United States, 43213
      • Columbus Clinical Research, Inc.
    • Marion, Ohio, United States, 43302
      • RAS Health LTD
    • Marion, Ohio, United States, 43302
      • PSB Research/P. S. Bains, M.S., D.O.
  • Oregon
    • Eugene, Oregon, United States, 97404
      • Willamette Valley Clinical Studies
  • Pennsylvania
    • Lansdale, Pennsylvania, United States, 19446
      • Green and Seidner Family Practice Associates
  • Texas
    • Corpus Christi, Texas, United States, 78404
      • Padre Coast Clinical Research
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • National Clinical Research - Norfolk, Inc.
    • Richmond, Virginia, United States, 23294
      • National Clinical Research - Richmond, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Main Inclusion Criteria:

• Fasting triglycerides 200-499 mg/dl
• Non-HDL-C > 130 mg/dl
• Stable statin treatment

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PRC-4016; PRC-4016, oral administration once daily, capsule	Drug: PRC-4016; Drug: Statins; Any statin allowed (i.e. rosuvastatin, simvastatin, pravastatin, atorvastatin etc)
Placebo Comparator: Placebo; Placebo, oral administration once daily, capsule	Drug: Placebo; Drug: Statins; Any statin allowed (i.e. rosuvastatin, simvastatin, pravastatin, atorvastatin etc)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percent change in Non-HDL-C from baseline to Week 12	from baseline to Week 12

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in triglycerides 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 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 ApoB 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 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
Change in red blood cell content of EPA and DHA 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

Collaborators and Investigators

• Sponsor: Pronova BioPharma
• Investigators: Study Director: Pål Nord, MD, MPH, Pronova BioPharma

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: October 24, 2013
• First Submitted That Met QC Criteria: October 24, 2013
• First Posted (Estimate): October 30, 2013

Study Record Updates

• Last Update Posted (Estimate): October 30, 2015
• Last Update Submitted That Met QC Criteria: October 7, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias
• Other Study ID Numbers: CTN 4016 13202