DyslipidemiaPhase 2NCT01893515
The Efficacy and Safety of PRC-4016 in Hypertriglyceridemic Subjects
A Phase 2 study testing PRC-4016 in people with Dyslipidemia, run by Pronova BioPharma at 39 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Dyslipidemia
- What is being tested?
- PRC-4016
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 87 participants
- Where
- 39 sitesUnited States
- Study dates
- Jul 2013to Jul 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
39 sites in 1 country.
39 sites in 1 country
United States39 sites
Pacific Oaks Medical Group
Beverly Hills, California, 90211
Mercury Street Medical
Butte, Montana, 59701
Sterling Research Group, Ltd. - Auburn
Cincinnati, Ohio, 45219
Metabolic and Atherosclerosis Research Center
Cincinnati, Ohio, 45227
Colorado Springs Health Partners
Colorado Springs, Colorado, 80920
Columbus Clinical Research, Inc.
Columbus, Ohio, 43213
Clinical Research of South Florida
Coral Gables, Florida, 33134
Padre Coast Clinical Research
Corpus Christi, Texas, 78404
Radiant Research - Edina
Edina, Minnesota, 55435
Willamette Valley Clinical Studies
Eugene, Oregon, 97404
Evanston Premier Healthcare Research LLC
Evanston, Illinois, 60201
Medisphere Medical Research Center
Evansville, Indiana, 47714
Peters Medical Research
High Point, North Carolina, 27262
Medical Affiliated Research Center, Inc.
Huntsville, Alabama, 35801
Jacksonville Impotence Treatment Center
Jacksonville, Florida, 32223
Green and Seidner Family Practice Associates
Lansdale, Pennsylvania, 19446
National Research Institute - Wilshire
Los Angeles, California, 90057
National Research Institute - East 118
Los Angeles, California, 90059
Louisville Metabolic and Atherosclerosis Research Center (L-MARC)
Louisville, Kentucky, 40213
PSB Research/P. S. Bains, M.S., D.O.
Marion, Ohio, 43302
RAS Health Ltd
Marion, Ohio, 43302
Terence Hart, MD
Muscle Shoals, Alabama, 35662
Heartland Research Assoc., LLC
Newton, Kansas, 67114
National Clinical Research - Norfolk, Inc.
Norfolk, Virginia, 23502
Lynn Health Science Institute - Oklahoma City
Oklahoma City, Oklahoma, 73112
UnitedResearch - Orangeburg, LLC
Orangeburg, South Carolina, 29118
Compass Research East, LLC
Oviedo, Florida, 32765
Central Phoenix Medical Clinic
Phoenix, Arizona, 85020
Progressive Medical Research
Port Orange, Florida, 32127
PMG Research of Raleigh, LLC
Raleigh, North Carolina, 27609
National Clinical Research - Richmond, Inc.
Richmond, Virginia, 23294
Research Across America - Santa Ana
Santa Ana, California, 92705
Encompass Clinical Research
Spring Valley, California, 91978
Meridien Research
St. Petersburg, Florida, 33709
Meridien Research- Tampa
Tampa, Florida, 33606
Troy Internal Medicine, P.C.
Troy, Michigan, 48098
Advanced Clinical Research
West Jordan, Utah, 84088
PMG Research of Wilmington, LLC
Wilmington, North Carolina, 28401
PMG Research of Winston-Salem, LLC
Winston-Salem, North Carolina, 27103
About this study
Official 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
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
Read the detailed description
6-8 weeks screening period with diet/lifestyle stabilization and lipid qualification
- Conditions
- Dyslipidemia
- Being tested
- PRC-4016, Placebo
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRC-4016Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| PRC-4016 | Experimental | PRC-4016, oral administration once daily, capsule Receives: Drug: PRC-4016 |
| Placebo | Placebo comparator | Placebo, oral administration once daily, capsule Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in triglycerides from baseline to week 12
Measured: from baseline to Week 12
Secondary outcomes (14)
Change in HDL-C from baseline to Week 12
Measured: from baseline to Week 12
Change in non-HDL-C from baseline to Week 12
Measured: from baseline to Week 12
Change in LDL-C from baseline to Week 12
Measured: from baseline to week 12
Change in VLDL-C from baseline to Week 12
Measured: from baseline to week 12
Change in total cholesterol from baseline to Week 12
Measured: from baseline to week 12
Change in ApoA1 from baseline to Week 12
Measured: from baseline to Week 12
Change in Apo B from baseline to Week 12
Measured: from baseline to week 12
Change in insulin from baseline to Week 12
Measured: from baseline to Week 12
Change in fasting plasma glucose from baseline to Week 12
Measured: from baseline to Week 12
Change in HbA1c from baseline to Week 12
Measured: from baseline to Week 12
Change in insulin resistance (HOMA) from baseline to Week 12
Measured: from baseline to Week 12
Change in Lp-PLA2 from baseline to Week 12
Measured: from baseline to Week 12
Change in hsCRP from baseline to Week 12
Measured: from baseline to Week 12
Change in red blood cell content of EPA and DHA from baseline to Week 12;
Measured: from baseline to Week 12;
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DyslipidemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pronova BioPharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pål Nord, MD, MPH, Study director, Pronova BioPharmaTraci A. Turner, MD, MT, Principal investigator, Metabolic and Atherosclerosis Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01893515
- Sponsor's protocol ID
- CTN 4016 13201
- Status last verified
- Oct 2015
- First submitted
- 28 Jun 2013
- Last updated
- 30 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bays HE, Hallen J, Vige R, Fraser D, Zhou R, Hustvedt SO, Orloff DG, Kastelein JJ. Icosabutate for the treatment of very high triglycerides: A placebo-controlled, randomized, double-blind, 12-week clinical trial. J Clin Lipidol. 2016 Jan-Feb;10(1):181-91.e1-2. doi: 10.1016/j.jacl.2015.10.012. Epub 2015 Nov 14.
PubMed 26892135
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT01893515
- Acronym / sponsor ID
- CTN 4016 13201
- Conditions
- Dyslipidemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Pronova BioPharmaIndustry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 9 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRC-4016 | Experimental | Drug: PRC-4016PRC-4016, oral administration once daily, capsule |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo, oral administration once daily, capsule |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRC-4016 | Drug | PRC-4016 |
| Placebo | Drug | Placebo |
Primary outcome
Percent change in triglycerides from baseline to week 12
Time frame: from baseline to Week 12
14 secondary outcomes
Change in HDL-C from baseline to Week 12
Time frame: from baseline to Week 12
Change in non-HDL-C from baseline to Week 12
Time frame: from baseline to Week 12
Change in LDL-C from baseline to Week 12
Time frame: from baseline to week 12
Change in VLDL-C from baseline to Week 12
Time frame: from baseline to week 12
Change in total cholesterol from baseline to Week 12
Time frame: from baseline to week 12
Change in ApoA1 from baseline to Week 12
Time frame: from baseline to Week 12
Change in Apo B from baseline to Week 12
Time frame: from baseline to week 12
Change in insulin from baseline to Week 12
Time frame: from baseline to Week 12
Change in fasting plasma glucose from baseline to Week 12
Time frame: from baseline to Week 12
Change in HbA1c from baseline to Week 12
Time frame: from baseline to Week 12
Change in insulin resistance (HOMA) from baseline to Week 12
Time frame: from baseline to Week 12
Change in Lp-PLA2 from baseline to Week 12
Time frame: from baseline to Week 12
Change in hsCRP from baseline to Week 12
Time frame: 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;
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2015.
- Derived from this study: PubMed 26892135Bays HE, Hallen J, Vige R, Fraser D, Zhou R, Hustvedt SO, Orloff DG, Kastelein JJ. Icosabutate for the treatment of very high triglycerides: A placebo-controlled, randomized, double-blind, 12-week clinical trial. J Clin Lipidol. 2016 Jan-Feb;10(1):181-91.e1-2. doi: 10.1016/j.jacl.2015.10.012. Epub 2015 Nov 14.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pål Nord, MD, MPH study director
Pronova BioPharma
Traci A. Turner, MD, MT principal investigator
Metabolic and Atherosclerosis Research Center
39 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PRC-4016 in people with Dyslipidemia, run by Pronova BioPharma at 39 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change in triglycerides from baseline to week 12 (time frame: from baseline to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01893515, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2015.