Effects of the GLP-1 Exenatide on Satiety in Lean and Obese Women

What Was Tested

This registered phase 1 trial tested Exenatide.

Obesity is a major health problem in the US and many Western countries, with more than half of the population being overweight or obese.

It had two arms (groups): Exenatide (active comparator) and Saline (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

The investigators primary study objective is to determine whether Exenatide changes the resting state activity of the brain, and alters the connectivity between brain regions involved in homeostatic and hedonic brain circuits.

The impact of gut peptides on the brain in the regulation of ingestive behavior is an area of great interest, since the involved signaling mechanisms may be potential targets for the treatment of obesity.

Both endocrine, paracrine and neurocrine (vagal) signaling pathways are involved in gut to brain signaling of nutrient related information (Holst, 2007).

Exenatide changes intrinsic activity in the NTS and hypothalamus, and connectivity between NTS and homeostatic and hedonic brain circuits 2.

Who Took Part

The registry lists 34 actual participants took part.

It was open to women only aged from 18 years up to 40 years.

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

Examples of who could join: FEMALES 18 to 40 years of age, inclusive. Lean control subjects with BMI's between 19 and 25kg/m2. Obese subjects with BMI's between 30 and 35kg/m2. Willingness to participate in this study as evidenced by a signed, written informed consent form (ICF). Willingness to avoid pregnancy and practice adequate birth control (abstinence, oral contraception, intrauterine devices, implantable devices, or barrier method with spermicide) during the time of study enrollment.

The full record lists 12 inclusion and 19 exclusion criteria; among the exclusions: current history of chronic pain; use of investigational drugs, products or devices within 28 days prior to screen and through study participation; subjects who have used diet aids within the last month.

How the Study Was Run

Design: randomized, crossover and triple-blind.

The participants were allocated by chance, so the Exenatide group and the comparison group should start out alike.

Each person switched between Exenatide and the comparison at some point, usually with a gap in between.

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

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

It started in 2011-12 with completion listed for 2012-12.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Resting State networks in the brain (time frame: one year).

It also tracked 1 secondary outcome, for example Age and body size differences.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Exenatide in 34 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Exenatide compound page, all human trials.