A Study of Tirzepatide in Overweight and Very Overweight Participants

What Was Tested

This registered phase 1 trial tested Tirzepatide and Liraglutide.

The main purpose of this study is to measure the effect of tirzepatide on food intake in participants who are overweight or very overweight.

The study will also use imaging to learn more about how tirzepatide affects specific parts of the brain.

It had three arms (groups): Tirzepatide (experimental), Placebo (placebo comparator) and Liraglutide (active comparator).

Participants received placebo administered into the SC tissue of the abdominal wall.

The registry classes the interventions as drug.

Who Took Part

The registry lists 114 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Have stable body weight for the past 1 month prior to screening. Have a body mass index (BMI) between 27 to 50 kilograms per meter squared (kg/m²), inclusive at screening. Willing and agreeable to commit to the duration of the study and undergo study procedures as instructed by the clinic staff. Women must not be pregnant or breastfeeding.

The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: have undergone or plan to undergo gastric bypass or bariatric surgery; have claustrophobia or have ferromagnetic implants that can interfere with completion of fmri measurements; unwilling to comply with smoking and alcohol restrictions during the study.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

Because people in this Tirzepatide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

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

Those kept unaware of assignments: participant and investigator.

It started in 2020-08-24 with completion listed for 2022-12-16.

It ran at 3 sites in United States (3).

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Change From Baseline in Calorie Intake in Participants Receiving Tirzepatide or Placebo at Week 3 (time frame: Baseline, Week 3).

It also tracked 2 secondary outcomes, for example Change From Baseline in Fasting and Postprandial Overall Appetite Visual Analog Scale (VAS) Score.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Tirzepatide and Liraglutide in 114 people.

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

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