Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2025-12-24 @ 9:07 PM
NCT ID:
NCT06467604
Eligibility Criteria:
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).
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT06467604
Study Brief:
Protocol Section:
NCT06467604