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 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 12:38 AM
NCT ID:
NCT06283667
Eligibility Criteria:
Inclusion Criteria:
* Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol)
* The decision to initiate treatment with commercially available Wegovy® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study
* Male or female, no age limitation
* Diagnosis of obesity disease; with either hypertension, dyslipidaemia or type 2 diabetes, insufficiently controlled with diet and exercise therapies, and should meet either of:
1. Body mass index (BMI)\* greater than or equal to 27 kilograms per meter square (kg/m\^2) with two or more obesity-related comorbidities\*\*, or
2. BMI\* greater than or equal to 35 kg/m\^2
* Participant who has never been exposed to Semaglutide or who started treatment with Wegovy® within the past 4 weeks at registration
* BMI calculation will be based on height and body weight recorded in the enrolment form of electronic case report form (eCRF) at enrolment.
* Definition of obesity-related comorbidities are in accordance with Japan Student Services Organization (JASSO) guideline 3: (1) impaired glucose tolerance, (2) dyslipidaemia, (3) hypertension, (4) hyper-uricemia/gout, (5) coronary artery disease, (6) cerebral infarction, (7) non-alcoholic fatty liver disease, (8) menstrual disorder/infertility, (9) obstructive sleep apnoea syndrome/obesity-hypoventilation syndrome, (10) locomotory disease or (11) obesity-related kidney disease.
Exclusion Criteria:
* Previous participation in this study. Participation is defined as having given informed consent in this study
* Treatment with any investigational drug within 30 days prior to baseline (Visit 1)
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
* A history of hypersensitivity to any ingredients of this drug
* Diabetic ketoacidosis, diabetic coma, pre-coma or type 1 diabetes mellitus \[The treatment with insulin is mandatory. It is not appropriate to use this drug\]
* In emergency cases such as severe infections and surgery in patients with type 2 diabetes \[It is desirable to control blood glucose with insulin; therefore, administration of this drug is not appropriate\]
* Pregnant or possibly pregnant female
* Female who plans to become pregnant within 2 months
Sex:
ALL
Study:
NCT06283667
Study Brief:
Protocol Section:
NCT06283667