Back to search results

Clinical and Neurobehavioral Changes With Weight Loss Drug Discontinuation and Reinitiation

This study aims to understand how stopping and restarting tirzepatide (a medication that helps manage blood sugar and appetite) affects your brain activity, behavior, and overall health. If you are an adult between 18 and 70 years old, currently taking tirzepatide, and receive care from the University of Texas-Southwestern (UTSW) Weight Wellness Clinic, you might be able to join. The study will look at changes in your brain's response to food images, as well as your hunger, mood, sleep, and daily functioning when you temporarily pause and then restart tirzepatide. The main goal is to see how these changes in brain activity are affected by stopping and restarting the medication.

Study design
This is an interventional study with 40 planned participants. It involves temporarily pausing and then restarting tirzepatide under medical supervision.
What's involved
You will temporarily pause your tirzepatide medication for 3-4 weeks and then restart it for 6-8 weeks. Brain activity will be measured at baseline (while on tirzepatide), during the discontinuation period, and after restarting the medication.
Compensation
Not stated in the trial record.
Follow-up
Brain activity will be measured at baseline, 3-4 weeks into discontinuation, and 6-8 weeks after re-initiation of tirzepatide.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07387796

Clinical and Neurobehavioral Changes With Weight Loss Drug Discontinuation and Reinitiation

Recruiting
NAAges 18–70InterventionalBasic science
The University of Texas at Dallas
~40 participants
Updated 2026-09-02 on ClinicalTrials.gov
What's tested:Discontinuation and Reinitiation of Tirzepatide

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change From On-Treatment to Discontinuation and Re-Initiation in Food Cue-Evoked BOLD Response in Reward and Salience Brain Regions
Measured over Baseline (on tirzepatide), 3-4 weeks of discontinuation, and 6-8 weeks of re-initiation

Conditions

Drug Discontinuation
Substance Use Disorders
Eating Behavior Changes
Tirzepatide

Explore related trials

Obesity

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Francesca Filbey, Doctor of Philosophy · PRINCIPAL_INVESTIGATOR · The University of Texas at Dallas

Who to contact

Samuel H Poelker-Wells, Master of Science
[email protected]
972-883-3375
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Aged 18-70 years.
Currently on tirzepatide.
Currently receiving care from University of Texas- Southwestern (UTSW) Weight Wellness Clinic.
Cognitively capable of understanding and signing informed consent.
Be proficient in English.

Exclusion

History of major neurological or psychiatric disorders, including substance use disorders that might confound brain imaging results (e.g., stroke, epilepsy, multiple sclerosis, schizophrenia, major depression requiring hospitalization).
Diagnosis of Type 2 Diabetes.
Current diagnosis of an eating disorder.
Use of medications affecting weight other than tirzepatide.
Pregnancy or breastfeeding.
MR contraindications:
Heart pacemaker, heart valve replacement, or aortic clips
Metal fragments in the eyes, skin, or elsewhere in the body
Brain clips or pieces of metal used in aneurysm surgery or intercranial bypass
Venous umbrella
Pieces of metal in the body resulting from work as a sheet-metal worker or welder
Clips placed in an internal organ
Prosthetic devices, such as middle ear, eye, joint, or penile implants
Joint replacement
Hearing aid that cannot be removed
Neurostimulator
Insulin pump
Shunts or stents
Metal mesh or coil implants
Metal plate, pin, screws, or wires, or any other metal implants

What this trial measures

  • Change From On-Treatment to Discontinuation and Re-Initiation in Food Cue-Evoked BOLD Response in Reward and Salience Brain RegionsBaseline (on tirzepatide), 3-4 weeks of discontinuation, and 6-8 weeks of re-initiation

    This outcome measures within-participant change in blood-oxygen-level-dependent (BOLD) signal during a food cue reactivity task, assessed using functional magnetic resonance imaging (fMRI). BOLD response will be quantified as the mean percent signal change in predefined reward- and salience-related regions of interest (including the ventral striatum and insula) during food image presentation relative to non-food control images. Higher BOLD values indicate greater neural responsivity to food cues.