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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01211847
Other study ID # CT013
Secondary ID
Status Completed
Phase Phase 2
First received September 29, 2010
Last updated January 9, 2014
Start date October 2010
Est. completion date December 2011

Study information

Verified date January 2014
Source Essentialis, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

Once a day oral administration with DCCR helps lower triglycerides


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,


Recruitment information / eligibility

Status Completed
Enrollment 44
Est. completion date December 2011
Est. primary completion date September 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility INCLUSION CRITERIA:

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

- 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

EXCLUSION CRITERIA:

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

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Diazoxide Choline Controlled-Release Tablet
DCCR 290 mg once a day for 126 days
Placebo
Placebo matching DCCR

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Essentialis, Inc. Medpace, Inc.

Outcome

Type Measure Description Time frame Safety issue
Primary Triglyceride-lowering efficacy of DCCR Fasting triglycerides (percent change from Baseline to Day 84) 84 days No
Secondary 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) 84 days No
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