GLP-1s to Enhance Lasting Optimal Weight

What Was Tested

This registered phase 4 trial tested Tirzepatide.

Participants will take tirzepatide weekly, have clinic visits every 4 weeks, meet study doctor and registered dietitian every 4 weeks in person or video conference, attend group intervention sessions twice a month via video conference, weigh daily with a study-provided smart scale, keep a record of all foods and beverages consumed, and use a study-provided activity tracker to keep track of daily step counts.

It had 1 arm (groups): Tirzepatide (experimental).

Tirzepatide injection once weekly for 9 months.

The registry classes the interventions as drug.

More on the Plan

Participants will be expected to weigh themselves daily on a smart scale, record their food and beverage consumption, and keep track of daily step counts over the 9-month intervention period.

This data will be used to examine the effects of tirzepatide on total and appendicular lean and total fat mass measured by DXA; hip and spine bone mineral density measured by DXA; and leg strength and physical performance (expanded Short Physical Performance Battery, 400-m walk).

Who Took Part

The registry lists 40 actual participants took part.

It was open to people of any sex aged from 65 years with no upper age limit.

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

Examples of who could join: BMI 30-37 kg/m2 or BMI 27-\<30 kg/m2 with at least 1 weight-related comorbidity. Able to provide own transportation to study visits. Willing to provide informed consent. Willing to take terzepatide for 9 months. Agree to all study procedures/assessments.

The full record lists 7 inclusion and 31 exclusion criteria; among the exclusions: dependent on a cane or walker or needing assistance with any activity of daily living; history of mild cognitive impairment or dementia or cognitive impairment on montreal cognitive assessment (moca score \<22); evidence of depressive symptoms (center for epidemiologic studies depression scale score =\>16.

How the Study Was Run

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

Everyone knew when Tirzepatide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

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

It started in 2025-07-07 with completion listed for 2027-10-30.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in total body lean mass (time frame: Baseline to Month 9). Change in total body lean mass (time frame: Month 9 to Month 21). Change in appendicular lean mass (time frame: Baseline to Month 9).

It also tracked 11 secondary outcomes, for example Change in thigh intramuscular fat tissue, Change in thigh muscle volume, Change in total skeletal muscle mass, Change in total volumetric bone mineral density of the hip, Change in hip bone strength and Change in total volumetric bone mineral density of the radius.

What This Means in Plain Language

Put simply, this is a phase 4 trial of Tirzepatide in 40 people.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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