A Pilot Study of Effects of Exenatide on Body Weight in Non-Diabetic, Obese Patients

What Was Tested

In this phase 2 trial, researchers set out to test Exenatide.

This is a multicenter study designed to compare the effect of exenatide plus a lifestyle modification plan versus placebo plus a lifestyle modification plan on weight loss in non-diabetic, obese subjects.

It had two arms (groups): Group A (experimental) and Group B (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

163 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Have a Body Mass Index (BMI) \>= 30kg/m\^2.

The full record lists 1 inclusion and 11 exclusion criteria; among the exclusions: have ever participated in this study previously, or any other study using exenatide (ac2993/ly2148568) or glp-1 analogs; diagnosis of diabetes mellitus (other than gestational diabetes), or previous use of anti-diabetic medications for \> 3 months; have had a change in prescribed lipid-lowering or blood pressure agents within 4 weeks of screening.

How the Study Was Run

It was run as a randomized, parallel-group and triple-blind study.

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 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, investigator and outcomes assessor.

It started in 2007-06 with completion listed for 2008-02.

It ran at 16 sites in United States (14) and Puerto Rico (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in Body Weight (time frame: 24 weeks).

It also tracked 15 secondary outcomes, for example Change in Body Mass Index (BMI), Change in Waist-to-hip Ratio, Change in Total Cholesterol, Change in High Density Lipoprotein (HDL) Cholesterol, Ratio of Endpoint (LOCF) to Baseline for Fasting Triglycerides (Logarithmically Transformed) and Change in Low Density Lipoprotein (LDL) Cholesterol.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Exenatide in 163 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.