Home › Drug Use and Addiction › NCT07387796

Clinical and Neurobehavioral Changes With Weight Loss Drug Discontinuation and Reinitiation

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

Who can join

Ages 18 to 70 · All sexes

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

About the study

The goal of this clinical study with research procedures is to learn how stopping and restarting tirzepatide (a medication that helps regulate blood sugar and appetite) affects brain activity, behavior, and health in adults ages 18-70 who are currently taking tirzepatide. Specifically, the study aims to examine how a short pause in tirzepatide affects hunger, mood, sleep, and daily functioning; how stopping and restarting tirzepatide alters brain chemistry and brain responses to food-related images; and how these changes relate to health measures such as quality of life and emotional well-being. There is no comparison group; instead, researchers will assess changes within each participant across three time points: while taking tirzepatide, after stopping it for 3-4 weeks, and after restarting it for 6-8 weeks. Participants will attend three in-person visits lasting approximately 3-4 hours each, during which they will complete interviews, questionnaires, and cognitive tasks; provide a urine sample (pregnancy screening for females); undergo a brain scan using magnetic resonance imaging (MRI) and MR spectroscopy (MRS); and receive a kit to provide a small stool sample. Participants will also complete two brief check-in phone calls between visits and the online BrainHealth Index between sessions, which includes surveys and cognitive tasks. All changes to tirzepatide use will occur under the supervision of a study physician to support participant safety and comfort, and the total study duration is approximately 13 weeks.

What is being tested

• Discontinuation and Reinitiation of Tirzepatide (other)

Sponsor: The University of Texas at Dallas · Participants: 40 · Started: 2026-10

Contact the study team

• Samuel H Poelker-Wells, Master of Science · Phone: 972-883-3375
• Aishwarya Veerkumar, Master of Public Health · Phone: 972-883-3304

Official record on ClinicalTrials.gov — NCT07387796

Locations in the U.S.

Conditions

• Drug Use and Addiction

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.