NCT07387796 Clinical and Neurobehavioral Changes With Weight Loss Drug Discontinuation and Reinitiation
| NCT ID | NCT07387796 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The University of Texas at Dallas |
| Condition | Drug Discontinuation |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2026-10 |
| Primary Completion | 2028-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2026-10 with a primary completion date of 2028-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Francesca Filbey, Doctor of Philosophy
PRINCIPAL INVESTIGATOR
The University of Texas at Dallas
Frequently Asked Questions
Who can join the NCT07387796 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Drug Discontinuation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07387796 currently recruiting?
Yes, NCT07387796 is actively recruiting participants. Contact the research team at sxp230129@utdallas.edu for enrollment information.
Where is the NCT07387796 trial being conducted?
This trial is being conducted at Dallas, United States.
Who is sponsoring the NCT07387796 clinical trial?
NCT07387796 is sponsored by The University of Texas at Dallas. The principal investigator is Francesca Filbey, Doctor of Philosophy at The University of Texas at Dallas. The trial plans to enroll 40 participants.