---
title: Diazoxide Choline Controlled-Release Tablet (DCCR) for Very High Triglycerides
nct_id: NCT00973271
overall_status: WITHDRAWN
phase: PHASE3
sponsor: Essentialis, Inc.
study_type: INTERVENTIONAL
primary_condition: Hypertriglyceridemia
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00973271.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00973271"
ct_last_update_post_date: 2016-09-01
last_seen_at: "2026-05-12T07:21:30.285Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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

**NCT ID:** [NCT00973271](https://clinicaltrials.gov/study/NCT00973271)

## Key Facts

- **Status:** WITHDRAWN
- **Why Stopped:** Did not continue with development of DCCR in Very High Triglycerides
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 0
- **Lead Sponsor:** Essentialis, Inc.
- **Conditions:** Hypertriglyceridemia
- **Start Date:** 2011-03
- **Completion Date:** 2011-12
- **CT.gov Last Update:** 2016-09-01

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **290 mg DCCR** (EXPERIMENTAL)
- **435 mg DCCR** (EXPERIMENTAL)
- **135 mg fenobric acid** (ACTIVE_COMPARATOR)
- **Placebo** (PLACEBO_COMPARATOR)

## Interventions

- **290 mg DCCR** (DRUG) — 290 mg diazoxide choline
- **435 mg DCCR** (DRUG) — 435 mg diazoxide choline
- **135 mg fenofibric acid** (DRUG) — 135 mg fenofibric acid
- **Placebo** (DRUG) — Placebos matching each of 2 doses of DCCR and 135 mg fenofibric acid
- **atorvastatin** (DRUG) — 20 mg atorvastatin

## Primary Outcomes

- **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 Outcomes

- **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)_

## Recent Field Changes (last 30 days)

- `design.enrollmentCount` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.whyStopped` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00973271.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00973271*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*