NCT07018544Enrolling By Invitation不适用
A Multicentre, Prospective, Single-arm, Non-interventional Regulatory Post-marketing Surveillance (rPMS) Study to Investigate the Safety and Effectiveness of Wegovy® (Semaglutide) in Patients With Obesity and Patients With Overweight in Routine Clinical Practice in Korea.
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 840
- 试验地点
- 8
- 主要终点
- Number (incidence) of AEs
研究概览
简要总结
This study is conducted to investigate the safety and effectiveness of semaglutide in participants with obesity and overweight in routine clinical practice. Participants will get semaglutide as prescribed by a doctor. This study will last for about 4 years and participants will participate in the study for approximately 26 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 semaglutide has been made by the participants and the treating physician before and independently from the decision to include the participant in this study.
- •Male or female adults, age above or equal to 19 years who is scheduled to start treatment with semaglutide based on the clinical judgment of their treating physician as specified in the Korean-prescribing Information (approved label in Korea) at the time of signing informed consent.
排除标准
- •Participants who are or have previously been on semaglutide therapy before enrollment.
- •Known or suspected hypersensitivity to the active substance or any of the excipients of semaglutide.
- •Previous participation in this study. Participation is defined as having given informed consent in this study.
- •Female participant 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 cooperation.
结局指标
主要结局
Number (incidence) of AEs
时间窗: From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks)
Count of events
次要结局
- The proportion of participants losing greater than or equal to 5% body weight(From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks))
- The proportion of participants losing greater than or equal to 10% body weight(From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks))
- Number (incidence) of ADRs(From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks))
- Number (incidence) of SAEs(From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks))
- Number (incidence) of SADRs(From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks))
- Number (incidence) of unexpected ADRs(From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks))
- Body weight loss(From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks))
- Number (incidence) of unexpected AEs(From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks))
- Number (incidence) of unexpected SAEs(From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks))
- Number (incidence) of unexpected SADRs(From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks))
- Total dose of semaglutide(From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks))
- The proportion of participants losing greater than or equal to 15% body weight(From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks))
研究者
研究点 (8)
Loading locations...
相似试验
尚未招募
Unknown
A study on the safety and efficacy of semaglutide in obese patientsObsesity patientsJPRN-UMIN000053714Kitasato University50
已完成
3 期
Research Study Comparing a New Medicine Semaglutide to Liraglutide in People With Type 2 DiabetesDiabetesDiabetes Mellitus, Type 2NCT03191396Novo Nordisk A/S577
已完成
不适用
A Research Study Looking at How Semaglutide Works in People With Type 2 Diabetes in United Kingdom, as Part of Local Clinical Practice (SURE UK)Diabetes Mellitus, Type 2NCT03876015Novo Nordisk A/S215
已完成
不适用
A Research Study Looking at How Semaglutide Works in People With Type 2 Diabetes in France, as Part of Local Clinical Practice (SURE FRANCE)Diabetes Mellitus, Type 2NCT04083820Novo Nordisk A/S521
已完成
不适用
A Research Study Looking at How Semaglutide Works in People With Type 2 Diabetes in The Netherlands, as Part of Local Clinical Practice (SURE NETHERLANDS)Diabetes Mellitus, Type 2NCT03929679Novo Nordisk A/S218