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NCT07387796 · ClinicalTrials.gov registry record · NA
Clinical and Neurobehavioral Changes With Weight Loss Drug Discontinuation and Reinitiation
A NA study, sponsored by The University of Texas at Dallas.
- Recruiting
- Registry status
- NA
- Development phase
- 40
- Enrollment target
NCT07387796: Recruiting NA study, sponsored by The University of Texas at Dallas.
NCT07387796 is a NA study that is actively recruiting participants, run by The University of Texas at Dallas. The registered enrollment target is 40 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07387796, a NA study, is actively recruiting participants, sponsored by The University of Texas at Dallas.
- RECRUITING
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
Study 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.
Primary Outcome
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 cue
Interventions
- OTHER Discontinuation and Reinitiation of Tirzepatide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2026-06 |
| Est. Completion | 2029-02 |
| Phase | NA |
What NCT07387796 shows while recruiting
NCT07387796 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Discontinuation and Reinitiation of Tirzepatide is the first listed.
NCT07387796 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07387796 about?
NCT07387796 is a clinical study titled "Clinical and Neurobehavioral Changes With Weight Loss Drug Discontinuation and Reinitiation". 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 aim...
What is the current status of trial NCT07387796?
This trial is currently recruiting. It is a NA study. The enrollment target is 40 participants. The study started on 2026-06. Estimated completion is 2029-02.
What interventions are being tested in trial NCT07387796?
The interventions under investigation include: Discontinuation and Reinitiation of Tirzepatide (OTHER).
Who is sponsoring clinical trial NCT07387796?
This trial is sponsored by The University of Texas at Dallas, which has 50 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07387796's enrollment target sits among peer trials
40 1447th of 2000 higher than 465 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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