The Effect of GLP-1 Agonist in Patients With Hypothalamic Obesity: Prospective, Pilot Study

What Was Tested

In this early phase 1 trial, researchers set out to test Liraglutide.

GLP-1 analogs are used as agents in the existing treatment of obesity.

It had 1 arm (groups): Patients diagnosed with a hypothalamic tumor. (experimental).

The registry classes the interventions as drug.

More on the Plan

Total duration of Saxenda treatment is 12 weeks.

Who Took Part

Enrollment: 50 planned participants were the target.

It was open to people of any sex aged from 19 years with no upper age limit.

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

Examples of who could join: Patients diagnosed with a hypothalamic tumor and treated surgically with confirmed hypothalamic damage. 19 years of age or older. Voluntarily agreed to participate in the study after receiving a full explanation of the study.

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: unable to fully understand the instructions for participation in the study or unable to give voluntary consent; taking medications that may affect weight, except for hormone replacement therapy, in the last 6 months; non-primary tumor patient.

How the Study Was Run

The set-up was single-group and open-label.

Nothing was hidden in this open-label Liraglutide study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2022-11-28 with completion listed for 2024-02-08.

It ran at 1 site in South Korea.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in weight (time frame: 3 month).

What This Means in Plain Language

Put simply, this is a early phase 1 trial of Liraglutide in 50 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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