Clinical trial

Clinical and Neurobehavioral Changes With Weight Loss Drug Discontinuation and Reinitiation

Recruiting now · Not applicable · 1 countries · Registry ID NCT07387796

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 70 Years

SexAll

Healthy volunteersNot accepted

ConditionDrug Discontinuation, Substance Use Disorders, Eating Behavior Changes, Tirzepatide

Full registry 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

Treatments and study arms

Discontinuation and Reinitiation of Tirzepatide

Other

Participants will temporarily pause their tirzepatide medication for 3-4 weeks and then restart it for 6-8 weeks under the supervision of a study physician. The medication change is done only for research purposes to study how stopping and restarting tirzepatide affects brain activity, appetite, mood, and other health measures. During this period, participants will complete MRI scans, behavioral assessments, questionnaires, and provide stool samples across three study visits.

Primary outcomes

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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Center for BrainHealth🇺🇸 Dallas, Texas, United States

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Samuel M Poelker-Wells, Master of ScienceContact

Email · Call 972-883-3375

Aishwarya Veerkumar, Master of ScienceContact