Effect of Exenatide in Obese Patients With Accelerated Gastric Emptying

What Was Tested

The trial (phase 4) is built around Exenatide.

The overall goal of this study was to determine the effect of exenatide on gastric emptying, satiety and satiation in obese participants.

The hypothesis in this study was that exenatide retards gastric emptying in obese patients with baseline accelerated gastric emptying.

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

Participants randomized to this arm received placebo subcutaneously twice daily for 30 days.

The registry classes the interventions as drug.

More on the Plan

Visit 1: Screening - physical exam, questionnaires, pregnancy test.

Participants were instructed to continue on the same diet and exercise routine during the entire study.

A baseline satiation/nutrient drink test was performed on Day 0 prior to initiation of exenatide or placebo.

The satiation/nutrient drink test involved drinking a liquid meal (Ensure) at a rate of one ounce per minute until no more could be ingested.

Who Took Part

The registry lists 20 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Women of childbearing potential will have negative pregnancy test before initiation of medication.

The full record lists 3 inclusion and 16 exclusion criteria; among the exclusions: unstable heart disease as evidenced by ongoing angina; congestive heart failure; concomitant use of appetite suppressants (i.e., caffeine based or diethylpropion) or orlistat (xenical®).

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-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.

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

As a double-blind Exenatide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2014-06 with completion listed for 2015-03.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Gastric Emptying Half-time (T 1/2) of Solids.

It also tracked 6 secondary outcomes, for example Percentage of Gastric Contents Emptied at 1 Hour, Change in Body Weight, Satiation Expressed as Volume to Fullness, Maximum Tolerated Volume, Buffet Meal Intake (kcal) and Aggregate Satiation Symptom Score.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Exenatide in 20 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.