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:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2025-12-26 @ 10:34 AM
NCT ID:
NCT06856928
Eligibility Criteria:
Inclusion Criteria:
* Adult males and females with a BMI of 30-45 kg/m2 (early group), or a BMI of 30-45 kg/m2 prior to weight loss achieved through medication (late group)
* Age, 25-60 years old
* Passing medical and physical screening, and analysis of blood and urine screening samples
* Anticipated to start or are already prescribed AOMs (semaglutide or tirzepatide)
* 6-months weight stable (early group) or 3 months weight stable at current weight (late group)
* Women of reproductive age must be using an effective form of contraception
Exclusion Criteria:
* Diagnosed with type 1 or 2 diabetes
* Smoker
* Previous surgical treatment or device-based therapy for obesity
* Chronic or acute pancreatitis
* Clinically significant gastric emptying abnormality
* Uncontrolled hypertension or hypo/hyperthyroidism
* Cardiovascular event 3 months within screening
* Acute or chronic hepatitis
* Inability to tolerate beef, eggs, and cheese
* Women who are pregnant
* Women who are nursing
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
60 Years
Study:
NCT06856928
Study Brief:
Protocol Section:
NCT06856928