Special Use - Results Surveillance on Long-term Use With Wegovy®
- Conditions
- Obesity
- Interventions
- Registration Number
- NCT06283667
- Lead Sponsor
- Novo Nordisk A/S
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 1000
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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
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Male or female, no age limitation
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Diagnosis of obesity disease; with either hypertension, dyslipidaemia or type 2 diabetes, insufficiently controlled with diet and exercise therapies, and should meet either of:
- 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
- BMI* greater than or equal to 35 kg/m^2
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Participant who has never been exposed to Semaglutide or who started treatment with Wegovy® within the past 4 weeks at registration
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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.
-
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Wegovy® Semaglutide Patients with obesity treated with Wegovy® (semaglutide) once weekly under real-world clinical practice conditions in Japan.
- Primary Outcome Measures
Name Time Method Number of Adverse Reactions (ARs) From baseline (week 0) to end of study (week 104) Measured as count of events
- Secondary Outcome Measures
Name Time Method 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 (%)
Number of Serious Adverse Reactions (SARs) 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
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)
Number of Adverse Events (AEs) From baseline (week 0) to end of study (week 104) Measured as count of events
Trial Locations
- Locations (110)
Nagoya City University Hospital_Obesity Treatment Center
🇯🇵Aichi, Japan
Kameda Medical Center_Diabetes and Endocrinology
🇯🇵Chiba, Japan
Mikannohana Clinic
🇯🇵Ehime, Japan
National Hospital Organization Fukuokahigashi Medical Center
🇯🇵Fukuoka, Japan
Fukuoka Kieikai Hospital_Diabetes and obesity centre
🇯🇵Fukuoka, Japan
Chuno Kosei Hospital_Endocrinology and Diabetes
🇯🇵Gifu, Japan
Murakami Memorial Hospital
🇯🇵Hiroshima, Japan
Kagoshima University Hospital_Diabetes and Endocrinology
🇯🇵Kagoshima, Japan
Showa University Fujigaoka Hospital_Internal Medicine
🇯🇵Kanagawa, Japan
Yokohama City Minato Red Cross Hospital
🇯🇵Kanagawa, Japan
Scroll for more (100 remaining)Nagoya City University Hospital_Obesity Treatment Center🇯🇵Aichi, Japan