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 @ 4:54 PM
Ignite Modification Date:
2025-12-24 @ 4:54 PM
NCT ID:
NCT07294950
Eligibility Criteria:
Inclusion Criteria:
* Men and women with previously diagnosed BMI ≥ 30 kg/m2 or BMI ≥ 27 kg/m2 and adiposity-related complications (such as osteoarthritis, nonalcoholic liver disease, sleep apnea, and hypertension) without preexisting cardiovascular disease or type 2 diabetes.
* Age 18 - 75 years inclusive
* Ongoing weight-loss treatment consisting of weekly subcutaneous semaglutide at minimum dose of 1 mg/weekly with documented weight reduction of at least 10% of pre-treatment body weight
* Stable weight over past 12 weeks (less than 5% change in body weight) (self-reported)
* Ability to read and understand English
Exclusion Criteria:
* Previously diagnosed cardiovascular disease defined as previous myocardial infarction, previous stroke, or symptomatic peripheral arterial disease.
* Currently pregnant or lactating
* Previously diagnosed type 2 diabetes
* Use of any other pharmacological treatment for weight-loss
* Previous surgical treatment for weight loss such as gastric bypass or gastric band
* Any history of eating disorder
* Renal dysfunction as evidenced by estimated glomerular filtration rate \< 25 ml/min by CKD-EPI Creatinine Equation
* New York Heart Association class II-IV heart failure
* Hepatic disease considered to be clinically significant (includes jaundice, chronic hepatitis, or previous liver transplant) or transaminases \>2.5X the upper limit of normal
* Malignant neoplasm requiring chemotherapy, surgery, radiation or palliative therapy within the previous 5 years (with the exception of basal cell skin cancer)
* Personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2
* Any other factor likely to limit adherence to the study, in the opinion of the investigators
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07294950
Study Brief:
Protocol Section:
NCT07294950