HypertriglyceridemiaPhase 2NCT01211847
Efficacy Study of Diazoxide Choline to Treat Hypertriglyceridemia
A Phase 2 study of Hypertriglyceridemia and Dyslipidemia, run by Essentialis, Inc..
Trial summary
Once a day oral administration with DCCR helps lower triglycerides Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertriglyceridemia, Dyslipidemia
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- Oct 2010to Dec 2011
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Fasting triglycerides
- Difference between Visit 3 (7 days prior to Baseline Visit) and Visit 4 (3 days prior to Baseline Visit) ≤ 60% (compared to the higher value of Visit 3 or Visit 4)
- Run-in Triglycerides* ≥ 500 mg/dL and < 1500 mg/dL *Run-in Triglyceride is defined as the average fasting triglycerides for Visit 3 (7 days prior to Baseline Visit) and Visit 4 (3 days prior to Baseline Visit).
- Statin use • Either Statin-naive
- Must not be on statin at Screening and remaining as such during the Run-in/Washout Period and throughout the study
- Or Statin-treated
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- Must be on Lipitor 20 mg initiated at the start of the Run-in/Washout Period and continue throughout the study
- Medication washout
- All subjects must be willing to undergo washout of all other lipid-lowering medications
- Glycemic status
- Fasting glucose < 126 mg/dL at Screening Visit
- HbA1c < 6.5% at Screening Visit
Who cannot join
- Medications: recent, current, anticipated
- Administration of investigational drugs within 1 month prior to Screening Visit
- Thyroid hormones or preparations within 1 month prior to Screening Visit (except in subjects on stable dose of replacement therapy for at least 1 month)
- Thiazide diuretics within 2 weeks prior to Screening Visit
- Discontinuation of beta-blockers within 1 month prior to Screening Visit or planned discontinuation of beta-blocker therapy
- Anticipated requirement for use of prohibited concomitant medications
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- History of allergic reaction or significant intolerance to:
- Diazoxide
- Thiazides
- Sulfonamides
- Fenofibrate or fenofibric acid derivatives
- Lifestyle changes
- Subjects intending to change exercise habits, quit smoking and/or quit alcohol use during the entire study
- Specific diagnoses, medical conditions and history
- Known type I or III hyperlipidemia
- Known type 1 DM
- Current diagnosis of type 2 DM
- Any other clinically significant endocrine, cardiovascular, pulmonary, neurological, psychiatric, hepatic, gastrointestinal, hematological, renal, or dermatological disease interfering with the assessments of the study medications, according to the Investigator
- Specific laboratory test results
- Any relevant biochemical abnormality interfering with the assessments of the study medications
About this study
Official title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study Assessing the Efficacy, Safety and Tolerability of Diazoxide Choline Controlled-Release Tablet (DCCR) in Subjects Without Diabetes Mellitus Having Very High Fasting Triglyceride Levels, With Double-Blind DCCR-Fenofibrate Combination Extension
Once a day oral administration with DCCR helps lower triglycerides
Read the detailed description
The population will consist of Statin-naive and Statin-treated subjects, all without diabetes mellitus, with fasting triglyceride levels in the range of ≥ 500 mg/dL and < 1500 mg/dL.
Subjects will be randomly assigned to 1 of 2 treatment groups: DCCR and Placebo
Approximately 44 subjects will be enrolled in the study and stratified by Statin use at a 1:1 ratio in each treatment group,
- Conditions
- Hypertriglyceridemia, Dyslipidemia
- Being tested
- Diazoxide Choline Controlled-Release Tablet, Placebo
- Keywords
- triglycerides, Apo B, non-HDL, statin, fenofibrate
- Medical subject headings
- Hypertriglyceridemia, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diazoxide Choline Controlled-Release TabletDrug
DCCR 290 mg once a day for 126 days
PlaceboDrug
Placebo matching DCCR
| Study group | Role | What they receive |
|---|---|---|
| DCCR | Experimental | DCCR Treatment with 290 mg Diazoxide Choline Receives: Drug: Diazoxide Choline Controlled-Release Tablet |
| Placebo | Placebo comparator | Placebo matching DCCR Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Triglyceride-lowering efficacy of DCCR
Fasting triglycerides (percent change from Baseline to Day 84)
Measured: 84 days
Secondary outcomes (1)
Improvement in other lipid profiles with DCCR
Apolipoprotein B (Apo B) (percent change from Baseline to Day 84) Fasting non-HDL cholesterol (percent change from Baseline to Day 84)
Measured: 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2010 (estimated)
- Study startOct 2010
- Primary completionSep 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertriglyceridemiaStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Essentialis, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medpace, Inc.
- Responsible party
- Sponsor
- Investigators
- Alain Baron, M.D., Study director, Essentialis, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01211847
- Sponsor's protocol ID
- CT013
- Status last verified
- Jan 2014
- First submitted
- 29 Sep 2010
- Last updated
- 10 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study Assessing the Efficacy, Safety and Tolerability of Diazoxide Choline Controlled-Release Tablet (DCCR) in Subjects Without Diabetes Mellitus Having Very High Fasting Triglyceride Levels, With Double-Blind DCCR-Fenofibrate Combination Extension
- ClinicalTrials.gov ID
- NCT01211847
- Acronym / sponsor ID
- CT013
- Conditions
- Hypertriglyceridemia, Dyslipidemia
- Keywords
- triglycerides, Apo B, non-HDL, statin, fenofibrate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Essentialis, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Medpace, Inc.
- Study start
- Oct 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 30 Sep 2010 (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.
Once a day oral administration with DCCR helps lower triglycerides
Detailed description
The population will consist of Statin-naive and Statin-treated subjects, all without diabetes mellitus, with fasting triglyceride levels in the range of ≥ 500 mg/dL and < 1500 mg/dL.
Subjects will be randomly assigned to 1 of 2 treatment groups: DCCR and Placebo
Approximately 44 subjects will be enrolled in the study and stratified by Statin use at a 1:1 ratio in each treatment group,
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DCCR | Experimental | Drug: Diazoxide Choline Controlled-Release TabletDCCR Treatment with 290 mg Diazoxide Choline |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo matching DCCR |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Fasting triglycerides
- Difference between Visit 3 (7 days prior to Baseline Visit) and Visit 4 (3 days prior to Baseline Visit) ≤ 60% (compared to the higher value of Visit 3 or Visit 4)
- Run-in Triglycerides* ≥ 500 mg/dL and < 1500 mg/dL *Run-in Triglyceride is defined as the average fasting triglycerides for Visit 3 (7 days prior to Baseline Visit) and Visit 4 (3 days prior to Baseline Visit).
- Statin use • Either Statin-naive
- Must not be on statin at Screening and remaining as such during the Run-in/Washout Period and throughout the study
Key exclusion criteria (20 listed)
- Medications: recent, current, anticipated
- Administration of investigational drugs within 1 month prior to Screening Visit
- Thyroid hormones or preparations within 1 month prior to Screening Visit (except in subjects on stable dose of replacement therapy for at least 1 month)
- Thiazide diuretics within 2 weeks prior to Screening Visit
- Discontinuation of beta-blockers within 1 month prior to Screening Visit or planned discontinuation of beta-blocker therapy
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 |
|---|---|---|
| Diazoxide Choline Controlled-Release TabletDCCR 290 mg once a day for 126 days | Drug | DCCR |
| PlaceboPlacebo matching DCCR | Drug | Placebo |
Primary outcome
Triglyceride-lowering efficacy of DCCR
Time frame: 84 days
Fasting triglycerides (percent change from Baseline to Day 84)
1 secondary outcome
Improvement in other lipid profiles with DCCR
Time frame: 84 days
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 10 Jan 2014.
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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.
Alain Baron, M.D. study director
Essentialis, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Hypertriglyceridemia and Dyslipidemia, run by Essentialis, Inc..
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 12 inclusion and 20 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 10 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Triglyceride-lowering efficacy of DCCR (time frame: 84 days). 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 10 Jan 2014.