The Efficacy and Safety of PRC-4016 in Hypertriglyceridemic Subjects

October 7, 2015 updated by: Pronova BioPharma

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

87

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Medical Affiliated Research Center, Inc.
      • Muscle Shoals, Alabama, United States, 35662
        • Terence Hart, MD
    • Arizona
      • Phoenix, Arizona, United States, 85020
        • Central Phoenix Medical Clinic
    • California
      • Beverly Hills, California, United States, 90211
        • Pacific Oaks Medical Group
      • Los Angeles, California, United States, 90057
        • National Research Institute - Wilshire
      • Los Angeles, California, United States, 90059
        • National Research Institute - East 118
      • Santa Ana, California, United States, 92705
        • Research Across America - Santa Ana
      • Spring Valley, California, United States, 91978
        • Encompass Clinical Research
    • Colorado
      • Colorado Springs, Colorado, United States, 80920
        • Colorado Springs Health Partners
    • Florida
      • Coral Gables, Florida, United States, 33134
        • Clinical Research of South 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
    • Montana
      • Butte, Montana, United States, 59701
        • Mercury Street Medical
    • North Carolina
      • High Point, North Carolina, United States, 27262
        • Peters Medical Research
      • Raleigh, North Carolina, United States, 27609
        • PMG Research of Raleigh, LLC
      • Wilmington, North Carolina, United States, 28401
        • PMG Research of Wilmington, LLC
      • Winston-Salem, North Carolina, United States, 27103
        • PMG Research of Winston-Salem, 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.
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Lynn Health Science Institute - Oklahoma City
    • Oregon
      • Eugene, Oregon, United States, 97404
        • Willamette Valley Clinical Studies
    • Pennsylvania
      • Lansdale, Pennsylvania, United States, 19446
        • Green and Seidner Family Practice Associates
    • South Carolina
      • Orangeburg, South Carolina, United States, 29118
        • UnitedResearch - Orangeburg, LLC
    • Texas
      • Corpus Christi, Texas, United States, 78404
        • Padre Coast Clinical Research
    • Utah
      • West Jordan, Utah, United States, 84088
        • Advanced 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PRC-4016
PRC-4016, oral administration once daily, capsule
Drug: PRC-4016
Placebo Comparator: Placebo
Placebo, oral administration once daily, capsule
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent change in triglycerides from baseline to week 12
Time Frame: from baseline to Week 12
from baseline to Week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in HDL-C from baseline to Week 12
Time Frame: from baseline to Week 12
from baseline to Week 12
Change in ApoA1 from baseline to Week 12
Time Frame: from baseline to Week 12
from baseline to Week 12
Change in insulin from baseline to Week 12
Time Frame: from baseline to Week 12
from baseline to Week 12
Change in fasting plasma glucose from baseline to Week 12
Time Frame: from baseline to Week 12
from baseline to Week 12
Change in HbA1c from baseline to Week 12
Time Frame: from baseline to Week 12
from baseline to Week 12
Change in Lp-PLA2 from baseline to Week 12
Time Frame: from baseline to Week 12
from baseline to Week 12
Change in hsCRP from baseline to Week 12
Time Frame: from baseline to Week 12
from baseline to Week 12
Change in non-HDL-C from baseline to Week 12
Time Frame: from baseline to Week 12
from baseline to Week 12
Change in LDL-C from baseline to Week 12
Time Frame: from baseline to week 12
from baseline to week 12
Change in VLDL-C from baseline to Week 12
Time Frame: from baseline to week 12
from baseline to week 12
Change in total cholesterol from baseline to Week 12
Time Frame: from baseline to week 12
from baseline to week 12
Change in Apo B from baseline to Week 12
Time Frame: from baseline to week 12
from baseline to week 12
Change in insulin resistance (HOMA) from baseline to Week 12
Time Frame: 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;
Time Frame: from baseline to Week 12;
from baseline to Week 12;

Other Outcome Measures

Outcome Measure
Time Frame
Safety assessments will include adverse events, clinical laboratory measurements (chemistry, hematology, and urinalysis), 12-lead ECGs, blood pressure, and physical examinations.
Time Frame: Up to 12 weeks
Up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pronova BioPharma

Investigators

  • Study Director: Pål Nord, MD, MPH, Pronova BioPharma
  • Principal Investigator: Traci A. Turner, MD, MT, Metabolic and Atherosclerosis Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

June 28, 2013

First Submitted That Met QC Criteria

July 2, 2013

First Posted (Estimate)

July 9, 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

Other Study ID Numbers

  • CTN 4016 13201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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