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HypertriglyceridemiaPhase 2NCT01516151

Assess the Safety and Efficacy of NKPL66 (CaPre™) in the Treatment of Mild-to-high Hypertriglyceridemia

A Phase 2 study testing CaPre™ and Lipid Lowering Medication in people with Hypertriglyceridemia, run by Grace Therapeutics Inc. at 38 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To evaluate the efficacy of 0.5, 1.0, 2.0 and 4.0 g/ day of CaPre™ in reducing fasting plasma serum triglycerides over a four week period in patients with mild-to-high hypertriglyceridemia as compared to the standard of care alone. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Hypertriglyceridemia
What is being tested?
CaPre™ and Lipid Lowering Medication
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
289 participants
Where
38 sitesCanada
Study dates
Dec 2011to Sep 2013
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male and female adults aged 18 to 75 years;
  • Fasting plasma levels of TG > 2.28 and < 10 mmol/L (200 and 877 mg/dL) on two occasions within 2 weeks (screening and baseline/part 1 visits).
  • Patients who are currently not on pharmacotherapy for hyperlipidemia and according to the judgement of the physician and Canadian Guidelines for the Diagnosis and Treatment of Dyslipidemia initiation of drug therapy is not indicated for the duration of the study.
  • OR
  • Patients currently treated with statins and according to the judgement of the physician and the Canadian Guidelines for the Diagnosis and Treatment of Dyslipidemia a change in their current drug regimen is not indicated for the duration of the study.
  • Patients treated with statin must be on stable dose for at least 6 weeks prior to screening;
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  • Patients are willing to follow the NCEP Step 1 Diet (see Appendix 4) for the duration of the study;
  • Female participants of childbearing potential (i.e. not surgically sterilized or post-menopausal greater than one year) must have negative serum pregnancy test and must be using an effective birth control method, defined as:
  • continuous use of oral or long acting injected contraceptive for at least 2 months prior to study entry, or;
  • use of an intra-uterine device or implantable contraceptive, or;
  • use of double barrier methods of birth control

Who cannot join

  • Any concomitant medication which in the opinion of the investigator would preclude the patient from successfully participating in the study;
  • Women who are pregnant or that are breast feeding;
  • Participation in another clinical trial within 30 days from initiation of the study;
  • Participants with a high risk for cardiovascular disease; (The definition of high-risk individuals will follow that of the 2009 Canadian Guidelines and include a) FRS >= 20% 10-year risk; b) All patients with uncontrolled diabetes (DCA guidelines) and c) Evidence of atherosclerosis -when this evidence was ascertained when clinically indicated);
  • Systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg. In diabetic patients, systolic blood pressure > 130 mmHg and/or diastolic blood pressure > 90 mmHg.
  • History of stroke, intermittent claudication or transient ischemic attack;
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  • Known unstable (uncontrolled) cardiac disease, within the last 6 months:
  • Patient with a clinically significant abnormal ECG at screening.
  • Patients with uncontrolled diabetes mellitus, with HbA1c > 7.0%;
  • Known diagnosis of hypoglycemia
  • Evidence of active renal disease indicated by a fasting estimated glomerular filtration rate (eGFR) of < 60 ml/min per 1.73 m2;
  • Increased plasma levels (>ULN) of amylase (as per respective lab upper limits) and / or lipase (>160 IU/L) or any indication of pancreatitis (increased alcohol consumption, gallstones);
  • History of pancreatitis;
  • Use of any lipid lowering medication other than statins (e.g niacin, fibrates or ezetimibe) and/or lipid lowering NHP within 6 weeks prior to the screening visit;
  • Intake of > 2 servings per week of fish or regimented use of fish oil/omega-3 supplements within 6 weeks prior to the screening visit;
  • Intake of fortified foods containing plant sterols within 6 weeks prior to the screening visit;
  • Known HIV or Hepatitis B or C positive;
  • Patients with osteoporosis and hormone sensitive conditions;
  • Patients with uncontrolled asthma as defined by the 2010 Consensus Summary of the Canadian Thoracic Society;
  • Known seafood allergy or allergy to any of the medicinal or non-medicinal ingredients of the study medication, including:
  • Omega-3 fatty acids (including EPA and DHA)
  • Phospholipids (mainly phosphatidylcholine)
  • Astaxanthin
  • Bovine gelatin
  • Coagulopathy or on anticoagulants. Platelet aggregation inhibitors (such as aspirin or clopidogrel but not heparin) are permitted in the study; patients taking both aspirin and clopidogrel are not permitted in the study;
  • Unable or unwilling to comply with the protocol;
  • Patient reported weight must be stable for the past 6 months (within 3kg variation);
  • Consumption of more than 14 standard alcoholic drinks a week.

Trial locations and contacts

38 sites in 1 country.

38 sites in 1 country

Canada38 sites

  • Study site

    Abbotsford British Columbia, British Columbia

  • Entralogix Clinical Research

    Aurora, Ontario

  • Entralogix Clinical Research

    Brampton, Ontario

  • Cambridge Cardiac Care Center

    Cambridge, Ontario

  • Thamesview Ctr of Family Med

    Chatam, Ontario

  • Moran Medical Centre

    Colingwood, Ontario

  • Clinique Medicale Valcartier

    Courcelette, Quebec

  • Clinique Reseau le Trait d'Union

    Delson, Quebec

  • Study site

    Dieppe, New Brunswick

  • Clinique Medicale Mistassini

    Dolbeau-Mistassini, Quebec

  • C & L Research

    Fort Erie, Ontario

  • Clinique medicale

    Grand-Mère, Quebec

  • GMF Grand Mere

    Grand-Mère, Quebec

  • G.S. Cardiac Lab Medicine Professional Corp

    Greater Sudbury, Ontario

  • Study site

    Hamilton, Ontario

  • CRM Lanaudiere

    Joliette, Quebec

  • Study site

    Kelowna, British Columbia

  • Entralogix Clinical Research

    Kitchener, Ontario

  • Entralogix Clinical Research

    Mississauga, Ontario

  • Malton Medical Research Group

    Mississauga, Ontario

  • Applied Medical Information Research AMIR

    Montreal, Quebec

  • Study site

    Niagara Falls, Ontario

  • Entralogix Clinical Research

    North York, Ontario

  • Taunton Health Centre

    Oshawa, Ontario

  • Steeple Hill Medical centre

    Pickering, Ontario

  • Centre de recherche A&E

    Québec, Quebec

  • Clinique des maladies lipidiques de Quebec Inc.

    Québec, Quebec

  • Alberta Health Services Clinical Trials

    Red Deer, Alberta

  • Clinique Services Sante Rosemere

    Rosemère, Quebec

  • Csss de St-Jerome

    Saint-Jérôme, Quebec

  • Entralogix Clinical Research

    Toronto, Ontario

  • Eric Silver Medicine Professional Corporation

    Toronto, Ontario

  • CSSS Vallee De L'Or

    Val-d'Or, Quebec

  • BC Diabetes

    Vancouver, British Columbia

  • Clinique Médicale des Trois Lacs

    Vaudreuil Dorion, Ontario

  • Study site

    Victoria, British Columbia

  • Applied Medical Information Research (AMIR)

    Westmount, Quebec

  • Study site

    Winnipeg, Manitoba

Other trials in Canada

About this study

Official title: A Randomized Open-label Dose-ranging, Multi-center Trial to Assess the Safety and Efficacy of NKPL66(CaPre™) in the Treatment of Mild-to-high Hypertriglyceridemia

To evaluate the efficacy of 0.5, 1.0, 2.0 and 4.0 g/ day of CaPre™ in reducing fasting plasma serum triglycerides over a four week period in patients with mild-to-high hypertriglyceridemia as compared to the standard of care alone.

Read the detailed description

The data generated from preclinical studies, as well as data accumulated from preclinical and clinical studies conducted with the precursor of CaPre™, NKO® , a natural health product (NPN: 80006416), have shown that CaPre™ is a safe product and well tolerated. In addition, there are preclinical data demonstrating that CaPre™ is effective in reducing circulating plasma concentrations of triglycerides. This effect is also accompanied by the regulation of other blood lipids, glucose tolerance and inflammatory biomarkers. These studies have been conducted in several preclinical adult phenotypes: (1) Healthy Sprague-Dawley (SD) rats, (2) obese and dyslipidemic Zucker Diabetic Fatty (ZDF) rats and(3-5) in three distinct murine phenotypes (normal wild-type C57BL/6, human ApoA-I transgenic mice and homozygous LDL-receptor knockout).

As the prevalence of cardiometabolic disorders progressively increase over the years, it is expected that there will be an augmentation in the necessity for new anti-dyslipidemic medications that can most importantly be added in combination to other treatments. Current treatment methods address a specific target indication, but do not offer complete management of dyslipidemia.

We are now left with the option to either inadequately treat patients suffering from cardiovascular and metabolic disorders or, to prescribe combination treatments hoping to address the risk factors while mitigating their known side effects. A treatment gap exists since there is no medication that increases HDL-cholesterol and reduces triglycerides while reducing LDL-cholesterol without side effects.

At present there is a need to assess the effectiveness of CaPre™ in reducing triglycerides in patients with high hypertriglyceridemia. The current study will address these issues and will generate the evidence that will be required to determine whether this product could be effectively used in the clinical management of this patient population.

Being tested
CaPre™, Lipid Lowering Medication
Keywords
Hypertriglyceridemia
Medical subject headings
Hypertriglyceridemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CaPre™Dietary supplement

    1 capsule of 0.5g total CaPre™ for 4 weeks followed by one 1.0g capsule per day for an additional 4 weeks

  • CaPre™Dietary supplement

    1 capsule of 1.0g total CaPre™ for 4 weeks followed by two 1.0g capsules per day for an additional 4 weeks

  • CaPre™Dietary supplement

    2 capsules of 1.0g total CaPre™ for 4 weeks followed by 4 capsules of 1.0g total per day for an additional 4 weeks.

  • Lipid Lowering MedicationDrug

    Patient will be treated as per the Standard of care.

  • CaPre™Dietary supplement

    4 capsules of 1 g total per day for 8 weeks.

Study groups in NCT01516151
Study groupRoleWhat they receive
Group AActive comparator0.5g total CaPre™ from baseline to week 4 and 1.0g total CaPre™ from week 4 to week 8
Receives: Dietary Supplement: CaPre™
Group BActive comparator1.0g total CaPre™ from baseline to week 4 and 2.0g total CaPre™ from week 4 to week
Receives: Dietary Supplement: CaPre™
Group CActive comparator2.0g total CaPre™ from baseline to week 4 and 4.0g total CaPre™ from week 4 to week 8
Receives: Dietary Supplement: CaPre™
Group DOtherStandard of care
Receives: Drug: Lipid Lowering Medication
Group EActive comparator4.0g total CaPre™ from baseline to week 8
Receives: Dietary Supplement: CaPre™

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent change in fasting blood circulating serum TGs

    The percent change in fasting blood circulating serum TGs between baseline and 4 weeks of treatment.

    Measured: Between baseline and 4 weeks of treatment.

Secondary outcomes (6)

  1. Absolute change in fasting plasma TGs

    Absolute change in fasting plasma TGs;

    Measured: Baseline, Week 4 and Week 8

  2. Patients achieving target TG fasting plasma levels

    Percentage (%) of patients achieving target TG fasting plasma levels (TG<1.7 mmol/L);

    Measured: Baseline

  3. Change in fasting plasma LDL-C, VLDL-C, HDL-C, total cholesterol, hs-CRP and non-HDL

    Absolute change in fasting plasma LDL-C, VLDL-C, HDL-C, total cholesterol, hs-CRP and non-HDL

    Measured: Between baseline and 4 and 8 weeks of treatment

  4. Change in fasting plasma concentrations of LDL-C, VLDL-C, HDL-C, total cholesterol, hs-CRP and non-HDL

    Percentage (%) change in fasting plasma concentrations of LDL-C, VLDL-C, HDL-C, total cholesterol, hs-CRP and non-HDL;

    Measured: Between baseline and 4 and 8 weeks of treatment

  5. Calculated ratios

    Calculated Ratios:

    1. Total cholesterol : HDL-C
    2. LDL-C : HDL-C
    3. TGs : HDL-C

    Measured: The percent change in fasting blood circulating serum TGs Between baseline and 4 and 8 weeks of treatment.

  6. Change in fasting plasma concentrations of biomarkers

    Absolute and percent (%) change in fasting plasma concentrations of biomarkers;

    1. Glycated Hemoglobin (HbA1c)
    2. Glucose
    3. Creatinine phosphokinase (CPK)

    Measured: Between baseline and 4 and 8 weeks of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jan 2012 (estimated)
  2. Study startDec 2011
  3. Primary completionMay 2013
  4. Study completionSep 2013

Resources

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
None (open label)
Enrolment
289 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01516151
Sponsor's protocol ID
PRT-API-NKPL66-CT-PIIB
Status last verified
Jan 2014
First submitted
19 Jan 2012
Last updated
8 Jan 2014
Results posted
No
Data monitoring committee
No

Publications

  • Kim KS, Belley-Cote EP, Walsh M, Wang A, Balasubramanian K, Treleaven N, Garg AX, Guyatt G, Whitlock RP. Left atrial appendage occlusion study III-Kidney substudy. Am Heart J. 2025 Oct;288:90-100. doi: 10.1016/j.ahj.2025.04.018. Epub 2025 Apr 19.

    PubMed 40258408

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CaPre™ and Lipid Lowering Medication in people with Hypertriglyceridemia, run by Grace Therapeutics Inc. at 38 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 28 exclusion criteria. 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 8 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in Canada. 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. 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 fasting blood circulating serum TGs (time frame: Between baseline and 4 weeks of treatment.). 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 NCT01516151, 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 8 Jan 2014.

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