Clinical and Neurobehavioral Changes With Weight Loss Drug Discontinuation and Reinitiation

Part of paid clinical trials in Dallas, Texas.

Sponsor
The University of Texas at Dallas
Study ID
NCT07387796
Status
Not Yet Recruiting

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Conditions

  • Drug Discontinuation
  • Eating Behavior Changes
  • Substance Use Disorders
  • Tirzepatide

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Feb 29, 2028
Completion
Feb 28, 2029

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Tirzepatide Discontinuation and Re-Initiation Arm
    Participants in this single-group arm will complete three study visits that occur while they are taking tirzepatide, during a 3-4 week pause from the medication, and after they restart tirzepatide for 6-8 weeks. All medication changes are supervised by a study physician. At each visit, participants will complete interviews, questionnaires, cognitive tasks, magnetic resonance imaging (MRI) brain scans, and provide stool samples. They will also complete two short check-in phone calls and an online BrainHealth Index assessment between visits.

Primary Outcome Measure

Change From On-Treatment to Discontinuation and Re-Initiation in Food Cue-Evoked BOLD Response in Reward and Salience Brain Regions [ Time Frame: Baseline (on tirzepatide), 3-4 weeks of discontinuation, and 6-8 weeks of re-initiation ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Center for BrainHealthDallasTexas75235
Samuel M Poelker-Wells, Master of Science
[email protected]
972-883-3375
Linnea L Stahl, Master of Science
[email protected]

Find similar trials in Dallas, TX

By research site
Center for BrainHealth· Dallas, TX

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