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 @ 9:38 PM
Ignite Modification Date:
2025-12-24 @ 9:38 PM
NCT ID:
NCT07232732
Eligibility Criteria:
Inclusion Criteria:
* Have a hemoglobin A1c level of less than 6.5 percent (%) at screening.
* Have a body mass index (BMI) of 25.0 to 45.0 kilogram per square meter (kg/m²), inclusive, at screening
* Participants assigned male at birth (AMAB) or participants assigned female at birth (AFAB) who are individual of childbearing potential (INOCBP) Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Exclusion Criteria:
* Have obesity induced by endocrine disorders such as Cushing's syndrome or Prader Willi syndrome.
* Have any of the following conditions at screening,
* supine systolic blood pressure of 160 millimeter of mercury (mmHg) or greater
* supine diastolic blood pressure of 100 mmHg or greater, or
* resting pulse rate of greater than 95 beats per minute (bpm) or less than 45 bpm. (Note: white-coat hypertension is excluded; therefore, if a repeated measurement of blood pressure after at least 5 minutes shows values within the range, the participant can be included).
* Have had any of the following within 6-months prior to screening
* myocardial infarction
* unstable angina
* coronary artery bypass graft
* percutaneous coronary intervention. (Note: diagnostic angiograms are permitted)
* transient ischemic attack
* cerebrovascular accident or decompensated congestive heart failure, or
* New York Health Association Class III or IV heart failure.
* Have serum triglyceride of 5 millimoles per liter (mmol/L) or greater (442 milligrams per deciliter \[mg/dL\]) at screening
* Have had any exposure to glucagon-like peptide-1 (GLP-1) analogs or other related compounds within the 3 months prior to screening
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07232732
Study Brief:
Protocol Section:
NCT07232732