Weight Loss With Exenatide Treatment

What Was Tested

The trial (phase 4) is built around Exenatide for fat loss, obesity & body recomposition.

The investigators will also examine the magnitude and duration of weight loss among a cohort of high responders over 52 weeks of treatment, and at 3 and 6 months following treatment.

Hypothesis: The mechanisms of weight loss with exenatide are not fully understood, and weight loss responses to exenatide are highly variable, possibly reflecting distinct metabolic parameters.

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

The registry classes the interventions as behavioral and drug.

More on the Plan

Secondary Outcomes their secondary objective is to identify metabolic characteristics that predict robust response to exenatide treatment.

Who Took Part

Enrollment: 249 actual participants took part.

It was open to women only aged from 18 years up to 70 years.

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

Examples of who could join: Females age 18-70. BMI 28-48 kg/m\^2. Stable weight (greater than 3 kg weight gain or loss within 6 months of screening visit). Ability to give informed consent and follow verbal and written instructions in English.

The full record lists 4 inclusion and 23 exclusion criteria; among the exclusions: type 1 or type 2 diabetes mellitus diagnosed according to american diabetes association criteria; unstable heart disease as evidenced by ongoing angina; congestive heart failure.

How the Study Was Run

The set-up was randomized, parallel-group and single-blind.

Random assignment meant chance, not the researchers, decided who got Exenatide and who got the comparison, which limits bias.

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

Only one side, usually the fat loss, obesity & body recomposition participants, was kept unaware of whether Exenatide was given.

Those kept unaware of assignments: participant.

It started in 2012-03 with completion listed for 2019-01.

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 Body Weight (time frame: 12 weeks).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Exenatide in 249 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.