A Study to Measure Energy Expenditure and Food Intake in Participants With Obesity Using Tirzepatide

What Was Tested

This registered phase 1 trial tested Tirzepatide.

This is a study of tirzepatide in participants with obesity.

The main purpose is to learn more about how tirzepatide affects the number of calories participants burn and the amount of food they eat.

The study lasted for 28 weeks and will include about 21 visits to the study center.

Participants received placebo once weekly (QW) by Subcutaneous (SC) injection.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 55 actual participants took part.

It was open to people of any sex aged from 18 years up to 60 years.

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

Examples of who could join: Have body mass index of 30 to 45 kilograms per square meter (kg/m²), inclusive. Have a stable body weight in the past 1 month prior to screening. Willing and agreeable to commit to the duration of the study and undergo study procedures as instructed by the clinic staff.

The full record lists 3 inclusion and 7 exclusion criteria; among the exclusions: have undergone gastric bypass or bariatric surgery; have a diagnosis of type 2 diabetes; have received prescription drugs or over the counter drugs that promote weight loss in the past 6 months prior to screening.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Tirzepatide and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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 2020-07-09 with completion listed for 2022-05-26.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Change From Baseline to Week 18 in Sleep Metabolic Rate (SMR) (time frame: Baseline, Week 18).

It also tracked 15 secondary outcomes, for example Change From Baseline to Week 18 in Food Intake During Ad Libitum Meal, Change From Baseline to Week 18 in 24-hour Energy Expenditure (EE), Change From Baseline to Week 18 in 24 Hour Respiratory Quotient (RQ), Change From Baseline to Week 18 in Sleep RQ, Change From Baseline to Week 18 in Duration of Periods With RQ<0.80 and Change From Baseline to Week 18 in Fat, Protein, and Carbohydrate Oxidation.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Tirzepatide in 55 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, all human trials.