NCT06283667进行中（未招募）不适用
A Multi-centre, Prospective, Non-interventional, Single-armed, 104 Weeks Post-marketing Study to Investigate Safety and Clinical Parameters of Wegovy® Once Weekly in Patients With Obesity Disease Under Real-world Clinical Practice Conditions
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,071
- 试验地点
- 224
- 主要终点
- Number of Adverse Reactions (ARs)
研究概览
简要总结
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •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
- •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.
排除标准
- •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
研究组 & 干预措施
Wegovy®
Patients with obesity treated with Wegovy® (semaglutide) once weekly under real-world clinical practice conditions in Japan.
干预措施: Semaglutide (Drug)
结局指标
主要结局
Number of Adverse Reactions (ARs)
时间窗: From baseline (week 0) to end of study (week 104)
Measured as count of events
次要结局
- Change in BMI (Body Mass Index)(From baseline (week 0) to end of study (week 104))
- Change in body weight after treatment discontinuation(From treatment discontinuation after at least 12 weeks to end of study (week 104))
- Number of Serious Adverse Reactions (SARs)(From baseline (week 0) to end of study (week 104))
- Number of serious adverse events (SAEs)(From baseline (week 0) to end of study (week 104))
- Change in body weight (Percent (%))(From baseline (week 0) to end of study (week 104))
- Change in body weight (Kilograms (Kg))(From baseline (week 0) to end of study (week 104))
- Change in waist circumference(From baseline (week 0) to end of study (week 104))
- Number of Adverse Events (AEs)(From baseline (week 0) to end of study (week 104))
研究者
研究点 (224)
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