Trial intelligence / Profile preview

Diazoxide Choline in Non-Diabetic Hypertriglyceridemia

NCT00696475Phase 2

Key facts

Status: Completed
Start: Jun 2008
Primary completion: Jan 2009
Countries: 1
Sponsor: Essentialis, Inc.
Modality: Small Molecules

Drugs: diazoxide
Conditions: hypertriglyceridemia

Overview

Phase 2, randomised, double-blind trial of diazoxide in hypertriglyceridemia (4 arms), sponsored by Essentialis, Inc. Primary endpoint: Triglycerides at 56 days. Started Jun 2008; status: completed.

Design

4 arms

Study design: RandomizedDouble-blind

Diazoxide choline Dose 1
Experimental arm receiving Diazoxide choline
Diazoxide choline Dose 2
Experimental arm receiving Diazoxide choline
Diazoxide choline Dose 3
Experimental arm receiving Diazoxide choline
Placebo
Placebo comparator arm

Who it enrols

Non-diabetic adults with hypertriglyceridemia (250-600 mg/dL) and BMI 18.5-45 kg/m^2.

Endpoints

Primary

Triglycerides56 days

Secondary

LDL, HDL, VLDL, and non-HDL cholesterol56 days
Insulin56 days
Glucose56 days
Body Weight56 days
Safety and Tolerability56 days

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