Morbid Obesity
Conditions
Interventions
Group A( Tirzepatide–Placebo Sequence):In Period 1, participants receive tirzepatide 5.0 mg by subcutaneous injection once weekly for 4 doses on Day 0, Day 7, Day 14, and Day 21. After a 30-day washou
Group B( Placebo–Tirzepatide Sequence):In Period 1, participants receive an equal-volume 0.9% sodium chloride injection once weekly for 4 doses on Day 0, Day 7, Day 14, and Day 21. After a 30-day wash
Sponsors
Shanghai Sixth People's Hospital
Eligibility
Sex/Gender
All
Age
16 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Agree and voluntarily participate in the experiment 2. Junior high school education or above 3. Possess a certain level of cognitive understanding 4. Be between 16 and 65 years old at the time of signing the informed consent form (ICF) 5. Body mass index (BMI) >28 kg/m^2
Exclusion criteria
Exclusion criteria: 1. Meets the criteria for current severe depression, bipolar disorder, schizophrenia, any mental illness (including drug-induced mental illness), and current drug-induced mood disorders; 2. Suffering from delusions, dementia, amnesia, obsessive-compulsive disorder, post-traumatic stress disorder, anxiety disorders, any personality disorder, as well as cognitive or dissociative disorders; 3. Has severe negative thoughts and behaviors; 4. Has cardiovascular and cerebrovascular diseases such as hypertension; 5. Other infectious diseases; 6. Experiencing sleep deprivation; 7. Previously underwent weight loss and metabolic surgery or major gastrointestinal surgery; 8. Has a history of taking medications such as amiodarone, methotrexate, tamoxifen, or glucocorticoids; 9. Concurrently has other serious diseases that affect the evaluation of this study and cannot cooperate; 10. Cannot understand the procedures and methods of this clinical study, refuses to participate, and refuses to sign the informed consent form; 11. Has intracranial metal implants, cochlear implants, increased intracranial pressure, brain trauma, incomplete skull, encephalitis, or brain tumor; 12. Scalp damage, ulcers, severe dermatitis, or unhealed wounds after recent head surgery; 13. Has undergone any type of weight loss surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in task-based and resting-state brain network activation and connectivity;Changes in food-cue-induced ERP amplitudes and theta/beta band power; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in body weight, BMI, and waist circumference;Changes in subjective food craving, behavioral, and emotional questionnaire scores; | — |
Countries
China
Contacts
Public ContactJianzhong Di
Shanghai Sixth People's Hospital
Outcome results
None listed