2024 Tirzepatide-Bariatric Surgery

What Was Tested

In this phase 4 trial, researchers set out to test Tirzepatide.

The outcome of this study could impact therapeutic guidelines for the multimodal treatment of obesity.

The major objectives are: 1.

It had two arms (groups): Standard of Care plus Drug (experimental) and Standard of Care Alone (active comparator).

Participant receives drug for 3 months prior to surgery.

The registry classes the interventions as behavioral and drug.

Who Took Part

50 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: BMI greater than or equal to 40 kg/m2 with one or more obesity-related comorbidities. Enrollment in the ADORE Bariatric Tissue Bank (IRB #69767).

The full record lists 4 inclusion and 14 exclusion criteria; among the exclusions: any contraindication to the use of tirzepatide (per package insert); personal or family history of medullary thyroid carcinoma; patients with multiple endocrine neoplasm syndrome type 2.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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.

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

It started in 2025-03-27 with completion listed for 2026-12-31.

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 inflammatory markers c reactive protein (CRP) (time frame: Baseline and 3 months post-drug). Change in inflammatory markers interleukin 6 (IL-6) (time frame: Baseline and 3 months post-drug). Change in inflammatory markers tumor necrosis factor (TNF) (time frame: Baseline and 3 months post-drug).

It also tracked 16 secondary outcomes, for example Change in weight, 30-day surgical complications, change in inflammatory markers c reactive protein (CRP), change in inflammatory markers interleukin 6 (IL-6), change in inflammatory markers tumor necrosis factor (TNF) and change in inflammatory markers (leptin).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Tirzepatide in 50 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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