Weight Loss Study for Patients With Obesity Due to Craniopharyngioma or Other Brain Tumor

What Was Tested

This registered phase 2 trial tested Exenatide for fat loss, obesity & body recomposition.

The purpose of this study is to determine whether exenatide can cause weight loss in patients with a history of craniopharyngioma or other brain lesion.

It had 1 arm (groups): Exenatide (experimental).

The registry classes the interventions as drug.

More on the Plan

Hypothalamic dysfunction can be due to tumor infiltration and as a consequence of surgery or radiation therapy.

Survivors who develop obesity have greater morbidity and mortality than normal weight survivors.

Exenatide (Byetta®) is a GLP-1 homologue that was FDA approved for treatment of type 2 diabetes in 2005.

The investigators hypothesize that treatment with exenatide will lead to weight loss in patients with hypothalamic obesity.

Who Took Part

Enrollment: 10 actual participants took part.

It was open to people of any sex aged from 18 years up to 40 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age 18 to 40 years old. History of craniopharyngioma or other lesion in the hypothalamic region. Greater than 6 months post-treatment, including chemotherapy, surgery or radiation.

The full record lists 5 inclusion and 12 exclusion criteria; among the exclusions: use of diabetes medications other than metformin in the past 12 weeks, including exenatide; use of weight loss drugs or initiation of a weight loss program in past 3 months; impaired renal function or history of kidney transplant.

How the Study Was Run

The set-up was single-group and open-label.

Being open-label, the Exenatide study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2012-06 with completion listed for 2015-03.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Body Weight (kg) (time frame: baseline, 50 weeks).

It also tracked 4 secondary outcomes, for example Resting Energy Expenditure (Kcals Per Day), Visual Analogue Scales for Post-meal Satiety, Insulin Secretion (Area Under the Curve) and Gastric Emptying Rate (13C-octanoic Acid Isotope Excretion Half Life).

What This Means in Plain Language

Put simply, this is a phase 2 trial of Exenatide in 10 people with fat loss, obesity & body recomposition.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Exenatide compound page, Fat loss, obesity & body recomposition research.