NCT07280221Enrolling By Invitation不适用
WEgovy Real World Assessment of Weight Loss in Korea (WE-WALK): a Multi-centre, Prospective, Single-arm, Nonintervention Study to Investigate the Effectiveness and Safety of Once-weekly Semaglutide 2.4 mg for People Living With Obesity in Routine Clinical Practice in Korea
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Percentage change in body weight
研究概览
简要总结
This study is to investigate the effectiveness and safety of Wegovy (semaglutide) in Korean patients living with obesity in routine clinical practice. The purpose of this study is to investigate the change in body weight and other clinical characteristics related to body weight in patients living with obesity. Participants will be treated with Wegovy (semaglutide) as prescribed by their doctor, in accordance with normal clinical practice. The study will last for about 52 weeks.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 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 (semaglutide) has been made by the patient and the treating physician before and independently from the decision to include the patient in this study.
- •Initiating treatment with Wegovy (semaglutide) for the first time and according to locally approved label.
- •Male or female, aged ≥ 19 years at the time of signing the informed consent.
排除标准
- •Previous participation in clinical studies including treatment with Wegovy (semaglutide). Participation is defined as providing informed consent in a previous study.
- •Female patient who is pregnant, breast-feeding, or intends to become pregnant and is of childbearing potential not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice).
- •Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation.
研究组 & 干预措施
Once weekly Wegovy
Participants will be treated with commercially available semaglutide. The treating physician will initiate treatment with commercially available semaglutide prior to and independently from the decision to include the participant in the study.
干预措施: Semaglutide (Drug)
结局指标
主要结局
Percentage change in body weight
时间窗: From baseline (week 0) to 24 weeks
Percent (%)
次要结局
- Achievement in body weight reduction ≥ 20%(From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks)
- Change in body composition of Lean body mass(From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks)
- Change in body composition of Total fat mass(From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks)
- Change in Body mass index (BMI)(From baseline (week 0) up to 8, 16, 24, 32, 40, 52 weeks)
- Absolute change in body weight(From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks)
- Percentage change in body weight(From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks)
- Achievement in body weight reduction more than or equal to (≥) 5%(From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks)
- Achievement in body weight reduction ≥ 10%(From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks)
- Achievement in body weight reduction ≥ 15%(From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks)
- Change in the proportion of patients by BMI Class I obesity (25 to 29.9 kg/m^2)(From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks)
- Change in the proportion of patients by BMI Class II obesity (30 to 34.9 kg/m^2)(From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks)
- Change in the proportion of patients by BMI Class III obesity (≥35 kg/m^2)(From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks)
- Change in waist circumference(From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks)
- Change in cardiometabolic parameters - Lipids: low-density lipoprotein cholesterol (LDL-C)(From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks)
- Change in cardiometabolic parameters - Lipids: triglycerides (TG)(From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks)
- Change in cardiometabolic parameters - Lipids: free fatty acid (FFA)(From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks)
- Change in status of type two diabetes mellitus (T2DM)(Baseline (week 0) to 52 weeks [or end of the study (EOS)])
- Change in status of Hypertension(Baseline (week 0) to 52 weeks (or EOS))
- Change in status of Dyslipidemia(Baseline (week 0) to 52 weeks (or EOS))
- Number of treatment-emergent adverse events (TEAEs)(From baseline (week 0) to 52 weeks (or EOS))
- Number of serious TEAEs(From baseline (week 0) to 52 weeks (or EOS))
- Change in cardiometabolic parameters - Systolic blood pressure (SBP)(From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks)
- Change in cardiometabolic parameters - Diastolic blood pressure (DBP)(From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks)
- Change in cardiometabolic parameters - Fasting plasma glucose (FPG)(From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks)
- Change in cardiometabolic parameters - Haemoglobin A1c (HbA1c)(From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks)
- Change in cardiometabolic parameters - Lipids: total cholesterol (TCh)(From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks)
- Change in cardiometabolic parameters - Lipids: high-density lipoprotein cholesterol (HDL-C)(From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks)
研究者
研究点 (1)
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