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The Efficacy and Safety of PRC-4016 in Hypertriglyceridemic Subjects

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01893515
Enrollment
87
Registered
2013-07-09
Start date
2013-07-31
Completion date
2014-07-31
Last updated
2015-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidemia

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

Interventions

DRUGPRC-4016
DRUGPlacebo

Sponsors

Pronova BioPharma
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frame
Percent change in triglycerides from baseline to week 12from baseline to Week 12

Secondary

MeasureTime frame
Change in fasting plasma glucose from baseline to Week 12from baseline to Week 12
Change in HbA1c from baseline to Week 12from baseline to Week 12
Change in insulin resistance (HOMA) from baseline to Week 12from baseline to Week 12
Change in Lp-PLA2 from baseline to Week 12from baseline to Week 12
Change in hsCRP from baseline to Week 12from 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 from baseline to Week 12from baseline to Week 12
Change in non-HDL-C from baseline to Week 12from baseline to Week 12
Change in LDL-C from baseline to Week 12from baseline to week 12
Change in VLDL-C from baseline to Week 12from baseline to week 12
Change in total cholesterol from baseline to Week 12from baseline to week 12
Change in ApoA1 from baseline to Week 12from baseline to Week 12
Change in Apo B from baseline to Week 12from baseline to week 12
Change in HDL-C from baseline to Week 12from baseline to Week 12

Other

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 15, 2026