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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01972178

Enrollment

113

Registered

2013-10-30

Start date

2013-11-30

Completion date

2014-08-31

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 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

Detailed description

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

Interventions

DRUGPRC-4016

DRUGPlacebo

DRUGStatins

Any statin allowed (i.e. rosuvastatin, simvastatin, pravastatin, atorvastatin etc)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 79 Years

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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
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 Lp-PLA2 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 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 insulin from baseline to Week 12	from baseline to Week 12

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026