CRAVE Study: Comparing Craving Responses and Diet Quality of GLP1 Receptor Agonist Users

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 orequal to 27.0 kg/m2) with the presence of at least one of the followingweight-related comorbidities (treated or untreated): hypertension, dyslipidemia,obstructive sleep apnea or cardiovascular disease and history of at least oneself-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 atleast 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'streatment 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 precedingscreening

4. Use of systemic hormonal therapies (contraceptive medication is allowed)

5. History of Type 1 or type 2 diabetes, HgbA1c ≥ 6.5% (gestational diabetes isallowed)

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 theinvestigator's judgment, should exclude participation

9. Documented chronic diseases including thyroid disease, kidney disease, activecancer, 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 2or medullary thyroid carcinoma

11. Current cancer or cancer treatment, or history of cancer or cancer treatment withinthe 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 anyother 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 previousparticipation 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 foodintake

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 mentalincapacity or language barriers

25. Any disorder, inability, or unwillingness to comply with the study protocol that mayjeopardize 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 ofestimated conception, and she will be excluded from further participation.

2. If a patient develops active cancer (except skin cancer), they will be excluded fromfurther participation due to safety concerns/contraindications for weight loss.

3. If a patient develops another exclusionary condition, such as unstable angina oranother condition for which weight loss or exercise might be contraindicated,further participation will be determined by the Medical Monitoring Team (PI, ProjectManager).