The Effect of Exenatide on Weight and Hunger in Obese, Healthy Women

What Was Tested

This registered phase 4 trial tested Exenatide.

This study will look at the effect of exenatide, a drug which has been approved for the treatment of type 2 diabetes, on body weight, appetite and energy expenditure among moderately obese women without diabetes.

The study is 35 weeks long and includes 19 outpatient visits.

Participants will receive exenatide for 16 weeks and placebo for 16 weeks with a 3 week rest period in between.

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

Started on Exenatide, 3 week washout, start placebo.

Started on placebo, 3 week washout, start exenatide.

The registry classes the interventions as drug.

More on the Plan

This study will examine the effect of exenatide on body weight, energy expenditure, satiety, sleep, and metabolic parameters in healthy, moderately obese women (BMI 28-35 kg/m2).

This is a randomized, double blind, crossover study with two 16-week treatment periods separated by a 3-week washout period.

There are 19 study visits over 35 weeks.

The primary outcome of this study is weight loss.

Who Took Part

Enrollment: 41 actual participants took part.

It was open to women only aged from 25 years up to 60 years.

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

Examples of who could join: Females aged 25-60. BMI 28-35 kg/m2. No known diagnosis of diabetes. No known diagnosis of coronary heart disease. Self-described sedentary lifestyle with minimal regular cardiovascular exercise (no more than 1 hour per week).

The full record lists 11 inclusion and 22 exclusion criteria; among the exclusions: type 1 or type 2 diabetes mellitus diagnosed according to american diabetes association criteria; coronary heart disease (history of myocardial infarction or unstable angina pectoris); uncontrolled hypertension hypertension (bp \> 150/90 mmhg on or off antihypertensive medication).

How the Study Was Run

Design: randomized, crossover 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.

In the crossover set-up each of the participants took both Exenatide and the comparison in turn, acting as their own control.

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 2007-04 with completion listed for 2010-09.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in Weight (time frame: 16 weeks after the beginning of each treatment). Change in Body Mass Index (time frame: 16 weeks from the start of each treatment period).

It also tracked 11 secondary outcomes, for example Change in Waist Circumference, Systolic Blood Pressure, Changes in Body Composition, Changes in Leptin, Diastolic Blood Pressure and Adiponectin.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Exenatide in 41 people.

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.