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Completed

NCT Number: NCT01893515

The Efficacy and Safety of PRC-4016 in 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

Completed

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Key information

Conditions

Dyslipidemia Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Medical Affiliated Research Center, Inc., Huntsville, Alabama, United States

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PRC-4016

Drug

Placebo

Drug

Primary outcomes

  1. Percent change in triglycerides from baseline to week 12

    Time frame: from baseline to Week 12

Secondary outcomes

  1. Change in HDL-C from baseline to Week 12

    Time frame: from baseline to Week 12

  2. Change in non-HDL-C from baseline to Week 12

    Time frame: from baseline to Week 12

  3. Change in LDL-C from baseline to Week 12

    Time frame: from baseline to week 12

  4. Change in VLDL-C from baseline to Week 12

    Time frame: from baseline to week 12

  5. Change in total cholesterol from baseline to Week 12

    Time frame: from baseline to week 12

  6. Change in ApoA1 from baseline to Week 12

    Time frame: from baseline to Week 12

  7. Change in Apo B from baseline to Week 12

    Time frame: from baseline to week 12

  8. Change in insulin from baseline to Week 12

    Time frame: from baseline to Week 12

  9. Change in fasting plasma glucose from baseline to Week 12

    Time frame: from baseline to Week 12

  10. Change in HbA1c from baseline to Week 12

    Time frame: from baseline to Week 12

  11. Change in insulin resistance (HOMA) from baseline to Week 12

    Time frame: from baseline to Week 12

  12. Change in Lp-PLA2 from baseline to Week 12

    Time frame: from baseline to Week 12

  13. Change in hsCRP from baseline to Week 12

    Time frame: from baseline to Week 12

  14. Change in red blood cell content of EPA and DHA from baseline to Week 12;

    Time frame: from baseline to Week 12;

Other outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Pronova BioPharma

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 9, 2013
Registry last updated
Oct 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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