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

Prior treatment

• Use of systemic hormonal therapies (contraceptive medication is allowed)
• Treatment with any GLP-1 Receptor Agonist medication(s) within 90 days of screening
• Documented chronic diseases including thyroid disease, kidney disease, active cancer, previous cardiovascular events, history or presence of chronic pancreatitis, or other gastrointestinal issues
• Prior use of other GLP-1RA or combination GIP/GLP-1RA medications or previous participation in any GLP-1RA trials
• Smoking, illicit drug use, vaporizer and/or electronic cigarette use

Other illness

• History of weight loss surgery
• History of major surgery within three months of enrollment
• History of Type 1 or type 2 diabetes, HgbA1c ≥ 6.5% (gestational diabetes is allowed)
• Significant kidney or liver disease, malnutrition, or any condition that, in the investigator's judgment, should exclude participation
• Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma
• Current cancer or cancer treatment, or history of cancer or cancer treatment within the last 3 years, excluding specific cases
• Diagnosis or strong clinical suspicion of eating disorders
• Background of significant active or unstable major depressive disorder (MDD) or any other severe psychiatric disorder within the past 2 years
• Lifetime history of a suicide attempt
• History of gastroparesis or other gut dysmotility syndrome
• Multiple patient-reported food allergies/intolerances significantly limiting food intake
• 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:
• If a patient develops active cancer (except skin cancer), they will be excluded from further participation due to safety concerns/contraindications for weight loss.
• 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).

Lab values

• Hemoglobinopathy that interferes with measurement of HbA1c

Other

• Recent weight fluctuations exceeding 5 kg within a 3-month period preceding screening
• Pregnant or lactating women, women planning to become pregnant in the next 12 months
• Currently consuming \>14 alcoholic drinks per week
• Extreme dietary or exercise patterns
• Individuals who are not yet adults (infants, children, teenagers)
• Individuals who are currently incarcerated or serving a prison sentence
• Individuals unable to provide informed consent due to factors such as mental incapacity or language barriers
• 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.

• Male or female, age 18.0-\<70 years
• 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.
• 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)
• Weight stable (+/- 5%) over previous 3 months
• Be under the care of a physician who will be responsible for managing participant's treatment regimen
• Willingness to provide food diary data throughout trial
• Access to a smartphone/tablet that can download the food logging application
• Willing and able to provide a valid email address for use in the study
• Be able to communicate (oral and written) in English
• Be able to provide informed consent