The Effects of Exenatide (Byetta ) on Energy Expenditure and Weight Loss in Nondiabetic Obese Subjects

What Was Tested

In this phase 3 trial, researchers set out to test Exenatide for fat loss, obesity & body recomposition.

This randomized, placebo-controlled study is to evaluate whether exenatide over a 5 week period in non-diabetic obese subjects may lead to weight loss.

To control for variability in individual response to weight loss treatment, this study will assess the role of exenatide in changing food intake and energy expenditure as possible sources of weight loss.

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

Twice daily.

The registry classes the interventions as behavioral, drug and other.

More on the Plan

The medical treatments currently available for obesity are limited.

Because response to weight loss treatment can be highly variable between individuals, the researchers will look at the role of exenatide in changing food intake and energy expenditure as possible explanations for weight loss.

The researchers will also assess the safety profile of exenatide in non-diabetic obese people.

The primary measurements will include effects of exenatide on energy expenditure and food intake.

Who Took Part

The registry lists 150 actual participants took part.

It was open to people of any sex aged from 18 years up to 55 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Premenopausal women and men \< 55 years of age. BMI \>30 kg/m(2). Expressed desire for weight loss. Stable weight (variation \< 2.3 kg within past 6 months). Ability to provide informed consent.

The full record lists 10 inclusion and 32 exclusion criteria; among the exclusions: age \< 18 years; history of an eating disorder including anorexia or bulimia; history of surgery for the treatment of obesity (gastric banding, gastric bypass).

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.

The Exenatide group and the comparison group ran side by side rather than switching.

Neither the fat loss, obesity & body recomposition participants nor the staff measuring them knew who was on Exenatide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2009-03-03 with completion listed for 2016-09-19.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Energy Intake (time frame: Day 6-7-8 (at baseline) and Day 12-13-14 (3 days after starting study intervention)). Twenty-four-hour Energy Expenditure (time frame: Day 5 and Day 11).

It also tracked 1 secondary outcome, for example Body Weight.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Exenatide in 150 people with fat loss, obesity & body recomposition.

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.