Clinical trial Recruiting at 1 site Interventional Ages 18 to 70

Weight-loss drug stoppage and restart effects on brain, mood, and daily life

Official title: Clinical and Neurobehavioral Changes With GLP-1 (Glucagon-like Peptide-1) Discontinuation

Run by The University of Texas at Dallas · NCT07387796 · Data updated 2026-11-12

This study tests what happens to brain signals, mood, sleep, and daily functioning when a tirzepatide user pauses the medication and then restarts it.

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Quick facts

Study typeInterventional
Ages18 Years to 70 Years
SexAll
Enrollment40 (estimated)
SponsorThe University of Texas at Dallas
Academic / other
Locations1 site (Dallas, Texas)
StatusRecruiting
StartedOctober 2026
Main results expectedFebruary 2028
Study endsFebruary 2029
Registry record updatedSeptember 2, 2026
Trial IDNCT07387796 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults 18-70 currently prescribed tirzepatide and receiving care at the UT Southwestern Weight Wellness Clinic who are able to consent and complete English-language assessments.

Probably not a fit

Individuals not experiencing changes in brain responses or daily functioning during the stop/restart period, or those with contraindications or intolerances to study procedures, may see no direct benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults aged 18-70 who are currently taking tirzepatide will undergo three in-person visits to measure changes in brain responses to food cues, behavior, and health outcomes as tirzepatide is stopped for 3-4 weeks and then restarted for 6-8 weeks. The study uses a within-subject design without a separate control group, focusing on changes across three time points: on tirzepatide, after discontinuation, and after reinitiation. Participants will complete interviews, questionnaires, and cognitive tasks and may undergo neuroimaging and other assessments as part of standard clinical care. All procedures are conducted in the context of routine prescribing and are not altering the patient’s medical treatment beyond the study timeline.

Why it matters

Potential benefit: If successful, the study could clarify how stopping and restarting tirzepatide impacts hunger, mood, and quality of life, informing safer use and management for patients.

How similar studies have gone: Prior work with similar within-subject approaches has shown potential to reveal brain and behavioral changes related to weight-management medications, though this exact stoppage/restart design is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 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 Criteria:

* 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

Where it's running

  • Center for BrainHealth
    Dallas, Texas, United States
    Recruiting

Study contacts

  • Principal investigator: Francesca Filbey, Doctor of Philosophy — The University of Texas at Dallas
  • Study coordinator: Samuel H Poelker-Wells, Master of Science
  • Email: sxp230129@utdallas.edu
  • Phone: 972-883-3375

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.