HypertriglyceridemiaPhase 3NCT00973271
Diazoxide Choline Controlled-Release Tablet (DCCR) for Very High Triglycerides
A Phase 3 study testing 290 mg DCCR, 435 mg DCCR and 135 mg fenofibric acid in people with Hypertriglyceridemia, run by Essentialis, Inc..
Trial summary
The hypothesis of this study is that DCCR is effective as both monotherapy and in combination with a statin in lowering triglycerides in subjects with very high triglycerides Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertriglyceridemia
- What is being tested?
- 290 mg DCCR, 435 mg DCCR and 135 mg fenofibric acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2011to Dec 2011
- Phase
- Phase 3
- 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
- No healthy volunteers
- 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
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- Or Statin-treated
- Must be receiving a stable and effective dose of statin for ≥ 3 months without significant side effects or intolerance prior to Screening
- Must be willing to switch to 20 mg atorvastatin 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
- Fasting LDL cholesterol
- ≤ l60 mg/dL at both Screening Visit and Visit 4
- 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 initial 12-week Placebo-Controlled Treatment Period of the study
- Specific diagnoses, medical conditions and history
- Known type I or III hyperlipidemia
- Known type 1 DM
- Known 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- and Active-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 Active-Controlled Extension Assessing Safety and Tolerability
The hypothesis of this study is that DCCR is effective as both monotherapy and in combination with a statin in lowering triglycerides in subjects with very high triglycerides
Read the detailed description
Very high triglyceride is a risk for pancreatitis. Studies have shown Diazoxide Choline has the potential to effectively lower triglycerides in patients with very high triglycerides.
- Conditions
- Hypertriglyceridemia
- Being tested
- 290 mg DCCR, 435 mg DCCR, 135 mg fenofibric acid, Placebo, atorvastatin
- 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.
290 mg DCCRDrug
290 mg diazoxide choline
435 mg DCCRDrug
435 mg diazoxide choline
135 mg fenofibric acidDrug
Also called 135 mg fenobric acid
135 mg fenofibric acid
PlaceboDrug
Also called Placebos matching DCCR and fenofibric acid
Placebos matching each of 2 doses of DCCR and 135 mg fenofibric acid
atorvastatinDrug
Also called 20 mg atorvastatin
20 mg atorvastatin
| Study group | Role | What they receive |
|---|---|---|
| 290 mg DCCR | Experimental | Not described Receives: Drug: 290 mg DCCR; Drug: Placebo; Drug: atorvastatin |
| 435 mg DCCR | Experimental | Not described Receives: Drug: 435 mg DCCR; Drug: Placebo; Drug: atorvastatin |
| 135 mg fenobric acid | Active comparator | Not described Receives: Drug: 135 mg fenofibric acid; Drug: Placebo; Drug: atorvastatin |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo; Drug: atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of DCCR on triglycerides in subjects without diabetes mellitus who have very high triglycerides over a period of 84 days
Measured: 84 days
Secondary outcomes (1)
The effects of DCCR on Apo B and non-HDL in subjects without diabetes mellitus who have very high triglycerides over a period of 84 days
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 posted9 Sep 2009 (estimated)
- Study startMar 2011
- Primary completionNov 2011
- Study completionDec 2011
Why it stopped: Did not continue with development of DCCR in Very High Triglycerides
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Essentialis, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00973271
- Sponsor's protocol ID
- PV011
- Status last verified
- Aug 2016
- First submitted
- 5 Sep 2009
- Last updated
- 1 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Double-Blind, Placebo- and Active-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 Active-Controlled Extension Assessing Safety and Tolerability
- ClinicalTrials.gov ID
- NCT00973271
- Acronym / sponsor ID
- PV011
- Conditions
- Hypertriglyceridemia
- Keywords
- hypertriglyceridemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Did not continue with development of DCCR in Very High Triglycerides
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Essentialis, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 9 Sep 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 hypothesis of this study is that DCCR is effective as both monotherapy and in combination with a statin in lowering triglycerides in subjects with very high triglycerides
Detailed description
Very high triglyceride is a risk for pancreatitis. Studies have shown Diazoxide Choline has the potential to effectively lower triglycerides in patients with very high triglycerides.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 290 mg DCCR | Experimental | Drug: 290 mg DCCR, Drug: Placebo, Drug: atorvastatin |
| 435 mg DCCR | Experimental | Drug: 435 mg DCCR, Drug: Placebo, Drug: atorvastatin |
| 135 mg fenobric acid | Active comparator | Drug: 135 mg fenofibric acid, Drug: Placebo, Drug: atorvastatin |
| Placebo | Placebo comparator | Drug: Placebo, Drug: atorvastatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 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
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 |
|---|---|---|
| 290 mg DCCR290 mg diazoxide choline | Drug | 290 mg DCCR |
| 435 mg DCCR435 mg diazoxide choline | Drug | 435 mg DCCR |
| 135 mg fenofibric acidAlso: 135 mg fenobric acid135 mg fenofibric acid | Drug | 135 mg fenobric acid |
| PlaceboAlso: Placebos matching DCCR and fenofibric acidPlacebos matching each of 2 doses of DCCR and 135 mg fenofibric acid | Drug | 135 mg fenobric acid, 290 mg DCCR, 435 mg DCCR, Placebo |
| atorvastatinAlso: 20 mg atorvastatin20 mg atorvastatin | Drug | 135 mg fenobric acid, 290 mg DCCR, 435 mg DCCR, Placebo |
Primary outcome
The effect of DCCR on triglycerides in subjects without diabetes mellitus who have very high triglycerides over a period of 84 days
Time frame: 84 days
1 secondary outcome
The effects of DCCR on Apo B and non-HDL in subjects without diabetes mellitus who have very high triglycerides over a period of 84 days
Time frame: 84 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 290 mg DCCR, 435 mg DCCR and 135 mg fenofibric acid in people with Hypertriglyceridemia, 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 16 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: withdrawn, as of the sponsor's last update on 1 Sep 2016. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was withdrawn before enrolling participants, so there are no results.
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?
The effect of DCCR on triglycerides in subjects without diabetes mellitus who have very high triglycerides over a period of 84 days (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 1 Sep 2016.