Obesity
Conditions
Brief summary
The purpose of the study is to investigate the safety and effectiveness of Wegovy® in patients with obesity disease under real-world clinical practice in Japan. Participants will get Wegovy® as prescribed by the study doctor. The study will last for about 4 years. Participant will be in the study for about 2 years (104 weeks).
Interventions
DRUGSemaglutide
Paricipants will be treated with commercially available Wegovy® according to routine clinical practice at the discretion of the treating physician, following approved label in Japan. The decision to initiate treatment with commercially available Wegovy® has been made by the patient and the treating physician before and independently from the decision to participate in this study.
Sponsors
Novo Nordisk A/S
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Adverse Reactions (ARs) | From baseline (week 0) to end of study (week 104) | Measured as count of events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Adverse Events (AEs) | From baseline (week 0) to end of study (week 104) | Measured as count of events |
| Number of serious adverse events (SAEs) | From baseline (week 0) to end of study (week 104) | Measured as count of events |
| Number of Serious Adverse Reactions (SARs) | From baseline (week 0) to end of study (week 104) | Measured as count of events |
| Change in body weight (Percent (%)) | From baseline (week 0) to end of study (week 104) | Measured as percent (%) |
| Change in body weight (Kilograms (Kg)) | From baseline (week 0) to end of study (week 104) | Measured in kilograms (Kg) |
| Change in waist circumference | From baseline (week 0) to end of study (week 104) | Measured in centimeters (cm) |
| Change in BMI (Body Mass Index) | From baseline (week 0) to end of study (week 104) | Measured in kilogram per meter square (kg/m\^2) |
| Change in body weight after treatment discontinuation | From treatment discontinuation after at least 12 weeks to end of study (week 104) | Measured as percent (%) |
Countries
Japan
Contacts
STUDY_DIRECTORClinical Transparency (dept. 2834)
Novo Nordisk A/S
Outcome results
None listed