Back to results

Diazoxide Choline Controlled-Release Tablet (DCCR) for Very High Triglycerides

Primary Purpose

Hypertriglyceridemia

Status

Withdrawn

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

290 mg DCCR

435 mg DCCR

135 mg fenofibric acid

Placebo

atorvastatin

About this trial

This is an interventional treatment trial for Hypertriglyceridemia focused on measuring hypertriglyceridemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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

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 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

290 mg DCCR

435 mg DCCR

135 mg fenobric acid

Placebo

Arm Description

Outcomes

Primary Outcome Measures

The effect of DCCR on triglycerides in subjects without diabetes mellitus who have very high triglycerides over a period of 84 days

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00973271

First Posted

September 5, 2009

Last Updated

August 30, 2016

Sponsor

Essentialis, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00973271

Brief Title

Diazoxide Choline Controlled-Release Tablet (DCCR) for Very High Triglycerides

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Withdrawn

Why Stopped

Did not continue with development of DCCR in Very High Triglycerides

Study Start Date

March 2011 (undefined)

Primary Completion Date

November 2011 (Actual)

Study Completion Date

December 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Essentialis, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertriglyceridemia

Keywords

hypertriglyceridemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

290 mg DCCR

Arm Type

Experimental

Arm Title

435 mg DCCR

Arm Type

Experimental

Arm Title

135 mg fenobric acid

Arm Type

Active Comparator

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

290 mg DCCR

Intervention Description

290 mg diazoxide choline

Intervention Type

Drug

Intervention Name(s)

435 mg DCCR

Intervention Description

435 mg diazoxide choline

Intervention Type

Drug

Intervention Name(s)

135 mg fenofibric acid

Other Intervention Name(s)

135 mg fenobric acid

Intervention Description

135 mg fenofibric acid

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Placebos matching DCCR and fenofibric acid

Intervention Description

Placebos matching each of 2 doses of DCCR and 135 mg fenofibric acid

Intervention Type

Drug

Intervention Name(s)

atorvastatin

Other Intervention Name(s)

20 mg atorvastatin

Intervention Description

20 mg atorvastatin

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 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 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 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

12. IPD Sharing Statement

Learn more about this trial

Diazoxide Choline Controlled-Release Tablet (DCCR) for Very High Triglycerides

We'll reach out to this number within 24 hrs