Efficacy and Safety of Exenatide in the Treatment of Hypothalamic Obesity After Craniopharyngioma Therapy

What Was Tested

This registered phase 3 trial tested Exenatide.

The purpose of the study is to compare the change of body weight after 6 months treatment with a lifestyle intervention + exenatide compare to the one after the same lifestyle intervention+ placebo in adults patients suffering from a hypothalamic obesity due to treatment of craniopharyngioma.

It had two arms (groups): Exenatide (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

The development of glucagon-like peptide-1 (GLP-1) analogues might be a solution since native GLP-1 suppresses appetite and energy intake in both normal weight and obese individuals as well as in people with type 2 diabetes and delays gastric emptying.

The underlying mechanisms that mediate the effects of weight involve not only central regions like the hypothalamus and the solitary tractus nucleus and area postrema but also peripheral regions as the gastrointestinal tract.

These extra hypothalamic effects are of particular interest in the cases of obesity due to hypothalamic lesions.

Exenatide is a glucagon-like peptide-1 (GLP-1) analogue with a high structural homology to human GLP-1, a gut derived incretin hormone.

Who Took Part

Enrollment: 42 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: They are between 18 and 75 yrs. They had been diagnosed with a craniopharyngioma treated by surgery and/or irradiation without sign of recurrence. They have a BMI upper than 30kg/m² with intractable weight gain following therapy for craniopharyngioma. All pituitary deficiencies are correctly treated. They gave their written, informed consent before the beginning of the study.

The full record lists 6 inclusion and 15 exclusion criteria; among the exclusions: they have type 1 diabetes; they have type 2 diabetes treated with insulin; bariatric surgery.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

Because people in this Exenatide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Exenatide.

Those kept unaware of assignments: participant and investigator.

It started in 2017-01-11 with completion listed for 2018-06-30.

It ran at 11 sites in France (11).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Compare body weight change thanks to weighing machine (time frame: baseline and 6 months).

It also tracked 18 secondary outcomes, for example Treatment tolerance thanks to digestive parameters, Treatment tolerance thanks to dermatologic parameter, Treatment tolerance thanks to pulse rate, Treatment tolerance thanks to Beck scale, Treatment tolerance thanks to HAD scale and Treatment tolerance thanks to enzymatic parameters.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Exenatide in 42 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Exenatide compound page, all human trials.