Individualized Obesity Pharmacotherapy

What Was Tested

In this phase 3 trial, researchers set out to test Liraglutide.

The researchers are trying to identify the specific characteristics (phenotypes) that may be useful to help select the right medication for weight loss.

It had two arms (groups): Intervention group (experimental) and Control Group (active comparator).

The registry classes the interventions as drug.

More on the Plan

All participants will be phenotype and participants will randomized to randomly assigned medications vs phenotype guided medications for obesity.

All participants will receive a standard intense lifestyle intervention.All participants will be seen at 4 and 12 weeks.

Study team will prospectively follow the patients' weight, waist circumference and use of obesity medications every 3 months for 1 year.

Who Took Part

193 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Adults with obesity (BMI \>30 Kg/m2); these will be otherwise healthy individuals with no unstable psychiatric disease and controlled comorbidities or other diseases. Gender: Men or women. Women of childbearing potential will have negative pregnancy tests within 48 hours of enrollment and before each radiation exposure.

The full record lists 2 inclusion and 5 exclusion criteria; among the exclusions: abdominal bariatric surgery; hypersensitivity to any of the study medications; no contraindications to all fda-approved medications.

How the Study Was Run

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

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

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

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

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

It started in 2017-12-11 with completion listed for 2022-05-26.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in Total Body Weight (time frame: baseline to 12 weeks).

It also tracked 2 secondary outcomes, for example Percentage of Responders and Percentage of Responders.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Liraglutide in 193 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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