Bioenergetic Alterations After Exenatide Administration

What Was Tested

This registered phase 4 trial tested Exenatide.

The purpose of this study is to find out how exenatide causes weight loss.

Specifically, the study is assessing how exenatide may change how people take in energy (energy intake), as well as how it may effect how people use energy (energy expenditure).

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

The registry classes the interventions as drug.

More on the Plan

The bioenergetics study is looking at how and why the diabetes drug exenatide causes people to lose weight.Bioenergetics is the study of how your body burns calories.

Adults 18-65 who do not have diabetes and have a body mass index (BMI) between 30 and 40 may be eligible.

Women who could get pregnant must be on birth control during the study and women who are pregnant cannot participate in the study.

Subjects will take exenatide for 12 weeks.

Who Took Part

28 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: 18-65 years of age. BMI between 30 and 40 kg/m2. Women with a negative pregnancy test at baseline, who are sterile, using contraceptives or in a committed relationship with someone who is sterile or using contraception. Absence of weight change greater than 3 kg in the previous 6 months.

The full record lists 4 inclusion and 14 exclusion criteria; among the exclusions: women who are pregnant or lactating; current or recent (6 months) enrollment in a commercial or self prescribed weight loss or exercise program; use of weight loss medication.

How the Study Was Run

Design: single-group and open-label.

Nothing was hidden in this open-label Exenatide study: the participants and staff both knew the treatment.

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

It started in 2008-01 with completion listed for 2010-04.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in Energy Intake Measured Before Treatment and at the End of Treatment (time frame: 3 months).

It also tracked 1 secondary outcome, for example Weight Loss After Administration of Exenatide.

What This Means in Plain Language

Put simply, this is a phase 4 trial of Exenatide in 28 people.

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, all human trials.