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CLIN-GLP1

Not yet recruitingPhase NA

Clinical and Neurobehavioral Changes With Weight Loss Drug Discontinuation and Reinitiation

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

Lead sponsor

The University of Texas at Dallas

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

Recruiting sites

—

Enrollment

estimated

Study population

Obesity / overweight

Key I/E criterion

—

Primary endpoint

•Change From On-Treatment to Discontinuation

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07387796

Org study IDIRB-26-3

Timeline

Milestones

Study first posted2026-02-04actual

Last update posted2026-05-29actual

Study start2026-06estimated (month precision)

Primary completion2028-02estimated (month precision)

Study completion2029-02estimated (month precision)

Assets

Investigational agents

Tirzepatide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

Maximum age70 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (26)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Patient-reported / QoL

Other clinical outcomes

Other (unclassified)

Patient-reported / QoL

16 endpoints

Secondary/protocol endpoint

Change From Baseline in State Food Craving Severity

Time frame:Baseline (on tirzepatide), 3-4 weeks of discontinuation, and 6-8 weeks of re-initiation

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Trait Food Craving Severity.

Time frame:Baseline (on tirzepatide), 3-4 weeks of discontinuation, and 6-8 weeks of re-initiation

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change From Baseline in Addictive-Like Eating Symptoms.

Time frame:Baseline (on tirzepatide), 3-4 weeks of discontinuation, and 6-8 weeks of re-initiation

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Intrusive Food-Related Thoughts.

Time frame:Baseline (on tirzepatide), 3-4 weeks of discontinuation, and 6-8 weeks of re-initiation

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Dietary Pattern Quality.

Time frame:Baseline (on tirzepatide), 3-4 weeks of discontinuation, and 6-8 weeks of re-initiation

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Perceived Loss of Control Over Eating.

Time frame:Baseline (on tirzepatide), 3-4 weeks of discontinuation, and 6-8 weeks of re-initiation

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Psychological Responsiveness to Food Availability.

Time frame:Baseline (on tirzepatide), 3-4 weeks of discontinuation, and 6-8 weeks of re-initiation

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Uncontrolled Eating Behavior.

Time frame:Baseline (on tirzepatide), 3-4 weeks of discontinuation, and 6-8 weeks of re-initiation

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Mood Disturbance.

Time frame:Baseline (on tirzepatide), 3-4 weeks of discontinuation, and 6-8 weeks of re-initiation

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Perceived Stress.

Time frame:Baseline (on tirzepatide), 3-4 weeks of discontinuation, and 6-8 weeks of re-initiation

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Emotional Health and Psychological Well-Being.

Time frame:Baseline (on tirzepatide), 3-4 weeks of discontinuation, and 6-8 weeks of re-initiation

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Quality of Life.

Time frame:Baseline (on tirzepatide), 3-4 weeks of discontinuation, and 6-8 weeks of re-initiation

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Withdrawal-Related Psychological Symptoms.

Time frame:Baseline (on tirzepatide), 3-4 weeks of discontinuation, and 6-8 weeks of re-initiation

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Sleep Quality as Measured by the Pittsburgh Sleep Quality Index

Time frame:Baseline (on tirzepatide), 3-4 weeks of discontinuation, and 6-8 weeks of re-initiation

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Risky and Impulsive Behavior.

Time frame:Baseline (on tirzepatide), 3-4 weeks of discontinuation, and 6-8 weeks of re-initiation

change from baseline, improvement

Other/protocol endpoint

Occurrence and Severity of Withdrawal-Related Symptoms During Medication Discontinuation

Time frame:Between baseline and discontinuation (about 2 weeks after baseline), and between discontinuation and re-initiation (about 4 weeks after start of re-initiation)

change from baseline, improvement

Other clinical outcomes

6 endpoints

Primary/protocol endpoint

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

percent change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Brain Neuromelanin Signal

Time frame:Baseline (on tirzepatide), 3-4 weeks of discontinuation, and 6-8 weeks of re-initiation

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change From Baseline in Attentional Bias Toward Food Cues.

Time frame:Baseline (on tirzepatide), 3-4 weeks of discontinuation, and 6-8 weeks of re-initiation

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Addiction-Related Problem Severity

Time frame:Baseline (on tirzepatide), 3-4 weeks of discontinuation, and 6-8 weeks of re-initiation

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Substance Use Frequency and Quantity.

Time frame:Baseline (on tirzepatide), 3-4 weeks of discontinuation, and 6-8 weeks of re-initiation

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in Multidimensional Brain Health as Measured by the BrainHealth Index

Time frame:Between baseline and discontinuation (about 2 weeks after baseline), and between discontinuation and re-initiation (about 4 weeks after start of reinitiation)

change from baseline, improvement

Other (unclassified)

4 endpoints

Secondary/protocol endpoint/low confidence

Change From Baseline in Resting-State Functional Connectivity Within Salience and Executive Control Networks

Time frame:Baseline (on tirzepatide), 3-4 weeks of discontinuation, and 6-8 weeks of re-initiation

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change From Baseline in Brain Glutamate Levels

Time frame:Baseline (on tirzepatide), 3-4 weeks of discontinuation, and 6-8 weeks of re-initiation

change from baseline, descriptive

Other/protocol endpoint/low confidence

Change From Baseline in Gut-Derived Neurotransmitter Levels.

Time frame:Baseline (on tirzepatide), 3-4 weeks of discontinuation, and 6-8 weeks of re-initiation

change from baseline, descriptive

Other/protocol endpoint/low confidence

Change From Baseline in Gut Microbiome and Inflammatory Marker Profiles

Time frame:Baseline (on tirzepatide), 3-4 weeks of discontinuation, and 6-8 weeks of re-initiation

change from baseline, descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

A global measure of perceived stress.
Journal of health and social behavior1983 Dec (month)PMID6668417via CT.gov background

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.