Effects of Tirzepatide Plus Intensive Lifestyle Therapy on Body Weight and Metabolic Health in Latinos With Obesity

What Was Tested

The trial (phase 4) is built around Tirzepatide.

Placebo or tirzepatide will be injected subcutaneously in the abdomen or thigh once a week for 12 months.

It had three arms (groups): Standard Care (active comparator), Intensive lifestyle intervention plus placebo (experimental) and Intensive lifestyle intervention plus tirzepatide (experimental).

The registry classes the interventions as behavioral and drug.

Who Took Part

It was open to people of any sex aged from 21 years up to 65 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Self-reported Hispanic and/or Latino heritage. Body Mass Index (BMI) 30-42 kg/m².

The full record lists 3 inclusion and 24 exclusion criteria; among the exclusions: CPAP treatment for obstructive sleep apnea; severe cardiovascular disease within the 6 months prior to study enrollment; severe organ system dysfunction.

How the Study Was Run

The set-up was randomized, parallel-group and triple-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.

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, investigator and outcomes assessor.

It started in 2023-09-13 with completion listed for 2024-05-29.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in body weight (time frame: After 24 weeks of intervention). Change in body weight (time frame: After 52 weeks of intervention).

It also tracked 33 secondary outcomes, for example Fat mass and fat free mass, Fat mass and fat free mass, β-cell function, β-cell function, Insulin clearance and Insulin clearance.

What This Means in Plain Language

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

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

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