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:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 12:36 AM
NCT ID:
NCT06075667
Eligibility Criteria:
Inclusion Criteria:
* Have obesity, as defined by BMI equal to or above the 95th percentile for age and sex, on age- and sex-specific growth chart, OR
* Have overweight, as defined by BMI equal to or above the 85th percentile but less than the 95th percentile for age and sex, on age- and sex-specific growth chart, with at least 1 weight-related comorbidity.
* dyslipidemia
* pre-hypertension
* hypertension
* nonalcoholic fatty liver disease
* obstructive sleep apnea
* prediabetes
* documented preexisting condition of Type 2 Diabetes
Participants with Type 2 Diabetes Mellitus (T2DM)
* Have been treated with either diet and exercise alone or stable treatment with metformin for at least 90 days prior to screening and have a HbA1c\<9.0%
Exclusion Criteria:
* Have a self-reported, or by parent or legal guardian where applicable, decrease in body weight more than 5 kilogram (kg) (11 lbs.) within 90 days before screening irrespective of medical records.
* Have Type 1 Diabetes
* Have taken within 90 days before screening or intend to start prescribed or over-the-counter medications, or alternative remedies including herbal or nutritional supplements, intended to promote body weight reduction.
* Are prepubertal (Tanner stage 1).
* Have a family or personal history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia (MEN) Syndrome Type 2
* Have a history of chronic or acute pancreatitis.
* Have undergone or plan to undergo weight reduction procedure during the study, such as, but not limited to
* gastric bypass
* sleeve gastrectomy
* restrictive bariatric surgery, such as Lap-Band gastric banding, or
* any other procedure intended to result in weight reduction.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
17 Years
Study:
NCT06075667
Study Brief:
Protocol Section:
NCT06075667