GLP-1 drugs: do they really change what you crave?

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male or female, age 18.0-\<70 years 2. Obese (BMI greater than or equal to 30.0 kg/m2) or overweight (BMI greater than or equal to 27.0 kg/m2) with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension, dyslipidemia, obstructive sleep apnea or cardiovascular disease and history of at least one self-reported unsuccessful dietary effort to lose body weight will be recruited. 3. On stable regimen of medications that can affect weight or diabetes outcomes for at least 3 months (brief regimens of medications such as antibiotics, steroids, etc. are permitted) 4. Weight stable (+/- 5%) over previous 3 months 5. Be under the care of a physician who will be responsible for managing participant's treatment regimen 6. Willingness to provide food diary data throughout trial 7. Access to a smartphone/tablet that can download the food logging application 8. Willing and able to provide a valid email address for use in the study 9. Be able to communicate (oral and written) in English 10. Be able to provide informed consent Exclusion Criteria: 1. History of weight loss surgery 2. History of major surgery within three months of enrollment 3. Recent weight fluctuations exceeding 5 kg within a 3-month period preceding screening 4. Use of systemic hormonal therapies (contraceptive medication is allowed) 5. History of Type 1 or type 2 diabetes, HgbA1c ≥ 6.5% (gestational diabetes is allowed) 6. Hemoglobinopathy that interferes with measurement of HbA1c 7. Treatment with any GLP-1 Receptor Agonist medication(s) within 90 days of screening 8. Significant kidney or liver disease, malnutrition, or any condition that, in the investigator's judgment, should exclude participation 9. Documented chronic diseases including thyroid disease, kidney disease, active cancer, previous cardiovascular events, history or presence of chronic pancreatitis, or other gastrointestinal issues 10. Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma 11. Current cancer or cancer treatment, or history of cancer or cancer treatment within the last 3 years, excluding specific cases 12. Diagnosis or strong clinical suspicion of eating disorders 13. Background of significant active or unstable major depressive disorder (MDD) or any other severe psychiatric disorder within the past 2 years 14. Lifetime history of a suicide attempt 15. History of gastroparesis or other gut dysmotility syndrome 16. Prior use of other GLP-1RA or combination GIP/GLP-1RA medications or previous participation in any GLP-1RA trials 17. Pregnant or lactating women, women planning to become pregnant in the next 12 months 18. Multiple patient-reported food allergies/intolerances significantly limiting food intake 19. Smoking, illicit drug use, vaporizer and/or electronic cigarette use 20. Currently consuming \>14 alcoholic drinks per week 21. Extreme dietary or exercise patterns 22. Individuals who are not yet adults (infants, children, teenagers) 23. Individuals who are currently incarcerated or serving a prison sentence 24. Individuals unable to provide informed consent due to factors such as mental incapacity or language barriers 25. Any disorder, inability, or unwillingness to comply with the study protocol that may jeopardize patient safety or compliance, based on the investigator's opinion Pregnancy and Other Exclusions during Trial: 1. If a patient experiences a pregnancy, her data will be censored from the time of estimated conception, and she will be excluded from further participation. 2. If a patient develops active cancer (except skin cancer), they will be excluded from further participation due to safety concerns/contraindications for weight loss. 3. If a patient develops another exclusionary condition, such as unstable angina or another condition for which weight loss or exercise might be contraindicated, further participation will be determined by the Medical Monitoring Team (PI, Project Manager).