Exenatide for the Treatment of Weight Gain Associated With Olanzapine in Obese Adults

What Was Tested

This registered phase 4 trial tested Exenatide.

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

The registry classes the interventions as drug.

More on the Plan

The researchers propose to conduct the study over the course of 24 months, with an expected enrollment of approximately 3 patients per month.

The primary outcome measure will be change from baseline to endpoint in weight.

Rates of adverse events also will be assessed.

Who Took Part

The registry lists 54 actual participants took part.

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

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

Examples of who could join: Subjects must be between the ages of 18 and 55 years old. Subjects must have bipolar I disorder, schizophrenia, schizoaffective disorder or MDD as defined by DSM-IV-TR criteria and diagnosed using the Structured Clinical Interview for DSM-IV (SCID). Subjects must have a Young Mania Rating Scale (YMRS) score \< 16 and a Montgomery-Asberg Depression Rating Scale (MADRS) score \< 24 at screening and baseline visits. Subjects must have the Scale for the Assessment of Positive Symptoms (SAPS) scores \<2 on all subscales. Subjects must be obese, as defined by a current Body Mass Index (BMI) \> 30 kg/m2.

The full record lists 9 inclusion and 8 exclusion criteria; among the exclusions: female patients who are either pregnant or lactating; any female patient whose sexual activity is unknown or in questions; neurological disorders including epilepsy, stroke, or severe head trauma. mental retardation (iq \<70).

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.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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, care provider and investigator.

It started in 2008-12 with completion listed for 2015-07.

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 From Baseline to Endpoint (time frame: 16 Weeks).

It also tracked 1 secondary outcome, for example Change in Body Mass Index (BMI) From Baseline to Endpoint.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Exenatide in 54 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.