HypercholesterolemiaPhase 1NCT00966225
LIP-01 in Hypercholesterolemia
A Phase 1 study testing LIP-01 in people with Hypercholesterolemia, run by Afexa Life Sciences Inc at 2 sites in 2 countries.
Trial summary
The purpose of this study is to determine a safe and tolerable dose of LIP-01 Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- LIP-01
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Sep 2009to Jan 2012
- Phase
- Phase 1
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 18-75 years
- Plasma total-cholesterol >5.2 mmol/L (> 200 mg/dL)
- Willingness to adhere to the requirements of the protocol, including availability for follow-up visits and donation of blood samples
- Willingness and ability to sign written informed consent
- Women of child bearing capacity who agree to use an acceptable form of birth control during the trial [i.e., oral contraception, reliable use of a double-barrier method (e.g., condom and diaphragm, condom and foam, condom and sponge), IUD or tubal ligation]
Who cannot join
- Plasma triglycerides > 4.0 mmol/L (> 354 mg/dL)
- Plasma LDL ≥ 5.0 mmol/L (≥ 195 mg/dL)
- Current coronary artery/ cardiovascular disease or history of a cardiovascular event (stroke, transient ischemic attack, myocardial infarction, angioplasty or coronary artery bypass grafting, angina pectoris)
- Moderate/high risk of coronary artery/ cardiovascular disease
- Diabetes mellitus
- Uncorrected hypothyroidism
Show all 19Show fewer
- Other significant metabolic endocrine disease
- Uncontrolled hypertension (>160 systolic or >100 diastolic)
- Active liver disease (ALT >2x normal)
- Significant gastrointestinal disease
- Acute inflammatory disease
- Significant kidney disease (calculated by eGFR <60 mL/min)
- Any other significant medical condition which, in the opinion of the investigator, could compromise patient safety or confound trial results
- Any significant/relevant surgery within the last year
- Use of lipid-lowering drugs
- Treatment within the previous 6 months with any medication that is known to affect lipid or lipoprotein levels (such as statins, fibric acid derivatives, bile acid sequestrants, ezetimibe, nicotinic acid)
- Regular use of natural health products or dietary supplements known to affect lipid or lipoprotein levels (omega-3 fatty acids, green tea extracts, guggulipid, psyllium, plant sterols, policosanols). If the participants agree to stop taking these products prior to study entry and for the duration of the study, they can participate in the study.
- Pregnant or lactating women
- Known allergy to any ingredient in the study product, including: Coptis chinensis, Ilex kudingcha, microcrystalline cellulose and magnesium stearate
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Canada1 site
The Northern Alberta Clinical Trials and Research Centre
Edmonton, Alberta, T6G 2C8
About this study
Official title: An Open-label Dose-finding Study of LIP-01 in Otherwise Healthy Individuals With Hypercholesterolemia
The purpose of this study is to determine a safe and tolerable dose of LIP-01
- Conditions
- Hypercholesterolemia
- Being tested
- LIP-01
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LIP-01Dietary supplement
comparison of different dosages of natural health product
| Study group | Role | What they receive |
|---|---|---|
| One gram LIP-01 per day | Experimental | One gram LIP-01 per day for 12 weeks Receives: Dietary Supplement: LIP-01 |
| Two grams LIP-01 per day | Experimental | Two grams LIP-01 per day for 12 weeks Receives: Dietary Supplement: LIP-01 |
| 0.333 grams LIP-01 per day | Experimental | 0.333 grams LIP-01 per day for 12 weeks Receives: Dietary Supplement: LIP-01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine a safe and tolerable dose of LIP-01
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2009 (estimated)
- Study startSep 2009
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Afexa Life Sciences Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard Lewanczuk, MD, PhD, FRCPC, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00966225
- Sponsor's protocol ID
- LIP-01-2009-1
- Status last verified
- Jan 2012
- First submitted
- 18 Aug 2009
- Last updated
- 31 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Dose-finding Study of LIP-01 in Otherwise Healthy Individuals With Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT00966225
- Acronym / sponsor ID
- LIP-01-2009-1
- Conditions
- Hypercholesterolemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Afexa Life Sciences IncIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 26 Aug 2009 (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 purpose of this study is to determine a safe and tolerable dose of LIP-01
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| One gram LIP-01 per day | Experimental | Dietary Supplement: LIP-01One gram LIP-01 per day for 12 weeks |
| Two grams LIP-01 per day | Experimental | Dietary Supplement: LIP-01Two grams LIP-01 per day for 12 weeks |
| 0.333 grams LIP-01 per day | Experimental | Dietary Supplement: LIP-010.333 grams LIP-01 per day for 12 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18-75 years
- Plasma total-cholesterol >5.2 mmol/L (> 200 mg/dL)
- Willingness to adhere to the requirements of the protocol, including availability for follow-up visits and donation of blood samples
- Willingness and ability to sign written informed consent
- Women of child bearing capacity who agree to use an acceptable form of birth control during the trial [i.e., oral contraception, reliable use of a double-barrier method (e.g., condom and diaphragm, condom and foam, condom and sponge), IUD or tubal ligation]
Key exclusion criteria (19 listed)
- Plasma triglycerides > 4.0 mmol/L (> 354 mg/dL)
- Plasma LDL ≥ 5.0 mmol/L (≥ 195 mg/dL)
- Current coronary artery/ cardiovascular disease or history of a cardiovascular event (stroke, transient ischemic attack, myocardial infarction, angioplasty or coronary artery bypass grafting, angina pectoris)
- Moderate/high risk of coronary artery/ cardiovascular disease
- Diabetes mellitus
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 |
|---|---|---|
| LIP-01comparison of different dosages of natural health product | Dietary supplement | 0.333 grams LIP-01 per day, One gram LIP-01 per day, Two grams LIP-01 per day |
Primary outcome
To determine a safe and tolerable dose of LIP-01
Time frame: 12 weeks
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 31 Jan 2012.
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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.
Richard Lewanczuk, MD, PhD, FRCPC principal investigator
University of Alberta
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LIP-01 in people with Hypercholesterolemia, run by Afexa Life Sciences Inc at 2 sites in 2 countries.
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 5 inclusion and 19 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 31 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
To determine a safe and tolerable dose of LIP-01 (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jan 2012.