NCT03560336已完成不适用
Prospective, Multicentre, Open-label, Single-arm, Non-interventional Regulatory Post-marketing Surveillance(rPMS) Study to Evaluate the Safety and Effectiveness of Saxenda® (Liraglutide 3.0 mg) in Obese Patients and Overweight Patients With Obesity-related Comorbidities in Routine Clinical Practice in Korea
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 758
- 试验地点
- 1
- 主要终点
- Incidence of adverse events (AEs) by preferred term (PT)
研究概览
简要总结
The purpose of this study is to collect information about the safety and effectiveness of Saxenda® in obese patients and overweight patients with obesity-related comorbidities. The participant will attend the clinic or hospital according to usual practice and receive medical care, as agreed with the study doctor. The participation is expected to be approximately for 26 weeks.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The decision to initiate treatment with commercially available Saxenda® has been made by the patient/Legally Acceptable Representative (LAR) and the physician before and independently from the decision to include the patient in this study - Informed consent obtained before any study-related activities Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study - Male or Female of Native Korean, age greater than or equal to 18 years who is scheduled to start treatment with Saxenda® based on the clinical judgment of physician as specified in the Korean-Prescribing Information (local label)
排除标准
- •Patients who are or have previously been on Saxenda® therapy - Known or suspected hypersensitivity to Saxenda® , the active substance or any of the excipients - 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 enrolment into the study - Female patient who is pregnant, breast-feeding, or intends to become pregnant and is of child-bearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by Korea regulation or practice) - Mental incapacity, unwillingness, or language barriers precluding adequate understanding or cooperation
研究组 & 干预措施
Overall Population
Patients will be treated with commercially available liraglutide 3.0 mg according to routine clinical practice at the discretion of the treating physician
干预措施: Liraglutide (Drug)
结局指标
主要结局
Incidence of adverse events (AEs) by preferred term (PT)
时间窗: From baseline to week 26 (± 3 weeks)
Count of events
次要结局
- Number of adverse drug reaction (ADRs)(From baseline to week 26 (± 3 weeks))
- Number of serious adverse events (SAEs) and serious adverse drug reations (SADRs)(From baseline to week 26 (± 3 weeks))
- Number of unexpected AEs and unexpected ADRs(From baseline to week 26 (± 3 weeks))
- Body weight loss (%) from week 0 to week 13(Week 0, week 13)
- Body weight loss (kg) from week 0 to week 26(Week 0, week 26)
- The proportion of patients losing more than 10% of week 0 body weight at week 13(Week 0, week 13)
- The proportion of patients losing more than 10% of week 0 body weight at week 26(Week 0, week 26)
- Number of unexpected SAEs and unexpected SADRs(From baseline to week 26 (± 3 weeks))
- Dose of liraglutide after administration initiation(week 26 (± 3 weeks))
- Body weight loss (%) from week 0 to week 26(Week 0, week 26)
- Body weight loss (kg) from week 0 to week 13(Week 0, week 13)
- The proportion of patients losing at least 5% of week 0 body weight at week 13(Week 0, week 13)
- The proportion of patients losing at least 5% of week 0 body weight at week 26(Week 0, week 26)
研究者
研究点 (1)
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