Trial intelligence / Profile preview

Byetta in Hypothalamic Obesity

NCT01484873Phase 2

Key facts

Status: Completed
Start: Jun 2012
Primary completion: Mar 2015
Countries: 1
Sponsor: Vanderbilt University Medical Center
Modality: Peptides

Drugs: exenatide
Conditions: obesity

Overview

Phase 2, open-label, single-arm trial of exenatide in obesity, sponsored by Vanderbilt University Medical Center. Primary endpoint: Body Weight at 50 weeks. Started Jun 2012; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-labelSingle group

Exenatide Arm
Single group receiving exenatide for 50 weeks.

Who it enrols

Adults aged 18-40 with hypothalamic obesity (BMI > 30) following craniopharyngioma or brain lesion treatment, with well-controlled HbA1c.

Endpoints

Primary

Body Weight50 weeks

Secondary

Resting Energy Expenditure50 weeks
Visual Analogue Scales for Post-meal Satiety50 weeks
Insulin Secretion Area Under the Curve50 weeks
Gastric Emptying Rate (13C-octanoic Acid Isotope Excretion Half Life)50 weeks

Beyond the preview

Go deeper on NCT01484873.

Full results, competitive context and analysis are in the Gosset platform.

Full results & analysis

Available in the Gosset platform where reported.

Competitive context

Available in the Gosset platform where reported.

Bring the full picture into focus.

See how Gosset can support your research on NCT01484873.