An Open-Label Tirzepatide Trial for Comorbid Obesity and Stimulant Use Disorder

What Was Tested

The trial (phase 2) is built around Tirzepatide.

Up to 30 participants will receive 20 weeks of once weekly tirzepatide, followed by an observational follow up period.

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

Eligible participants who are enrolled will receive once-weekly subcutaneous injections of tirzepatide for a 20-week period in accordance with FDA-prescribing label guidelines.

The registry classes the interventions as drug.

More on the Plan

In addition, all participants will undergo magnetic resonance imaging (MRI), including structural and functional (fMRI) scans, at screening and baseline, as well as at Weeks 6, 20, 24, 28, and 32, for a total of seven scans over the course of the trial.

The screening scan may be completed same day as the screening visit or scheduled on another day based on scanner availability.

Participants will also receive 12 weekly contingency management (CM) in conjunction with cognitive behavioral therapy (CBT) during the 12 weeks.

These combined measures will provide them with a comprehensive evaluation of tirzepatide and its potential impact on behavior and brain function/patterns in individuals with moderate/severe methamphetamine, cocaine, and stimulant use disorder.

Who Took Part

45 planned participants were the target.

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: Be 18 to 65 years of age, inclusive. Be able to provide informed consent and ask relevant questions. Stated willingness to comply with all study procedures and availability for the duration of the study. Be willing to adhere to the study medication regimen. Meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for moderate or severe methamphetamine, cocaine or prescription stimulant use disorder.

The full record lists 11 inclusion and 18 exclusion criteria; among the exclusions: current or recent use (within 3 months prior to consent) of other tirzepatide-containing products or any other glp-1 (glucagon-like peptide-1) receptor agonist; current or recent use (within 30 days) of sulfonylureas, other concomitantly administered insulin secretagogue, or insulin; current or recent use (within 3 months prior to consent) of other weight loss agents.

How the Study Was Run

Design: single-group and open-label.

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

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

It started in 2026-08-19 with completion listed for 2030-02-01.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Effect of tirzepatide on self-reported use of stimulants (time frame: 32 weeks).

It also tracked 4 secondary outcomes, for example Changes in body mass index from baseline to the end of the 20-week treatment phase, Feasibility of using tirzepatide in individuals with Stimulant Use Disorder, Changes in High-sensitivity C-reactive protein (hs-CRP) levels from baseline to the end of the 20-week treatment phase and Changes in gastrointestinal symptom severity from baseline until the end of the 20-week treatment phase.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Tirzepatide in 45 people.

Its status is enrolling by invitation; no results are posted to the registry yet, so nothing here describes outcomes.

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