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 @ 4:23 AM
Ignite Modification Date:
2025-12-25 @ 4:23 AM
NCT ID:
NCT06973720
Eligibility Criteria:
Inclusion Criteria:
* Body mass index (BMI) at Screening of:
* BMI ≥30 kg/m2 and ≤50.0 kg/m2 (can have the weight-related co-morbidities listed below)
* BMI ≥27.0 kg/m2 to \<30.0 kg/m2 with at least one of the following weight-related co-morbidities:
1. Hypertension: on blood pressure (BP)-lowering medication or having systolic BP ≥130 mmHg or diastolic BP ≥80 mmHg at Screening
2. Dyslipidemia: on lipid-lowering medication or having low-density lipoprotein cholesterol (LDL-C) ≥160 mg/dL (4.1 mmol/L) or triglycerides ≥150 mg/dL (1.7 mmol/L), or high-density lipoprotein-cholesterol (HDL-C) \<40 mg/dL (1.0 mmol/L) for men or HDL-C \<50 mg/dL (1.3 mmol/L) for women at Screening
3. Stable body weight (increase or decrease ≤5 kg) within 3 months prior to Screening
Exclusion Criteria:
* Diagnosis of diabetes (T1DM or T2DM) or glycated hemoglobin A1c (HbA1c) ≥ 6.5% or fasting plasma glucose \>125 mg/dL.
* Estimated glomerular filtration rate (eGFR) \<75 mL/min/1.73 m2
* History of pancreatitis
* Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
* History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder within the last 2 years
* Poorly controlled hypertension at, defined as any of the following:
* Mean seated systolic BP ≥160 mm Hg or mean seated diastolic BP ≥95 mm Hg at Screening visit
* A change in antihypertensive medications within 30 days of Screening visit
* Renal artery stenosis, or evidence of labile blood pressure including symptomatic postural hypotension at Screening; postural hypotension is defined as a sustained reduction of systolic blood pressure of at least 20 mmHg or diastolic blood pressure of 10 mmHg, with or without symptoms during the assessment, within three minutes of standing
* Thyroid-stimulating hormone (TSH) level lower than 0.4 mIU/L or higher than 6.0 mIU/L at the Screening visit. Note: participants receiving treatment for hypothyroidism may be included, provided their thyroid hormone replacement dose has been stable for at least 6 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT06973720
Study Brief:
Protocol Section:
NCT06973720