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NCT00696475 · ClinicalTrials.gov registry record · Phase 2

Diazoxide Choline in Hypertriglyceridemia

A Phase 2 study, sponsored by Essentialis.

Completed
Registry status
Phase 2
Development phase
80
Enrollment target

NCT00696475: Completed Phase 2 study, sponsored by Essentialis.

NCT00696475 is a Phase 2 study that has completed, run by Essentialis. The registered enrollment target is 80 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00696475, a Phase 2 study, has completed, sponsored by Essentialis.

COMPLETED
Registry status
Phase 2
Development phase
80 participants
Enrollment target

Study Summary

Hypertriglyceridemia affects 30% of the population in the US. Very high level of triglycerides is a known risk factor for pancreatitis. In addition, studies have shown that hypertriglyceridemia is an independent risk factor for cardiovascular disease. Diazoxide is a KATP channel opener. It has been approved by the FDA as an oral suspension for the treatment of hyperinsulinemic hypoglycemic conditions and as an IV solution for malignant hypertension. Preclinical and clinical studies suggest that diazoxide can be a potential therapeutic agent for hypertriglyceridemia. Diazoxide choline is a novel, highly crystalline proprietary salt of diazoxide, which has been formulated as a controlled-release tablet suitable for once per day dosing. This current study is designed to assess the effect of diazoxide choline on triglycerides in subjects with baseline hypertriglyceridemia. In addition, the effects on other lipid parameters, glucose and insulin, body weight as well as the safety and tolerability of diazoxide choline will be assessed.

Interventions

  • DRUG Placebo
  • DRUG Diazoxide choline

Trial Details

FieldValue
Enrollment Target 80 participants
Start Date 2008-06
Est. Completion 2009-03
Phase Phase 2
Essentialis

4 total trials

What the finished NCT00696475 record still lists

NCT00696475 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT00696475 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00696475 about?

NCT00696475 is a clinical study titled "Diazoxide Choline in Hypertriglyceridemia". Hypertriglyceridemia affects 30% of the population in the US. Very high level of triglycerides is a known risk factor for pancreatitis. In addition, studies have shown that hypertriglyceridemia is an independent risk factor for cardiovascular disease. Diazoxide is a KATP channel opener. It has been...

What is the current status of trial NCT00696475?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2008-06. Estimated completion is 2009-03.

What interventions are being tested in trial NCT00696475?

The interventions under investigation include: Placebo (DRUG), Diazoxide choline (DRUG).

Who is sponsoring clinical trial NCT00696475?

This trial is sponsored by Essentialis, which has 4 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00696475's enrollment target sits among peer trials

80 842nd of 2000 higher than 1,117 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00696475, the US trial registry maintained by the National Library of Medicine. NCT00696475 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.