NCT05438186撤回不适用
A Retrospective, Multi-centre, Non-interventional Study Investigating the Clinical Parameters Associated With Saxenda® Use and Discontinuation in Patients in Turkey. INSPIRE Turkey (INvestigate the Impact of Saxenda® on Patient's Weight In a REal World Setting in Turkey) Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Relative change in body weight
研究概览
简要总结
The study is investigating the use of Saxenda (liragltuide 3.0 milligrams (mg) once daily) for weight management. The primary objective is to investigate the change in body weight after initiation and use of Saxenda ® according to local clinical practice for weight management, on adult participant's in a real world setting in Turkey. The study will last for about 5 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Patients who have signed consent before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
- •Patients who have polyclinic visits between 01 June 2022 and 31 October 2022 and who have received initial prescription of Saxenda® for weight management at least 52 weeks prior to study enrolment.
- •Patients who have maintained treatment with Saxenda® for at least 16 weeks, without treatment break, following the initial prescription.
- •Patients who have 12-month follow-up data, even if discontinued Saxenda ® treatment.
- •Patients who have body weight measurement at baseline and at least 1 more body weight measurement following the Saxenda® prescription
- •Age greater than or equal 18 years at the time of signing informed consent
- •Exclusion criteria:
- •Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
- •Patient charts lacking any follow-up information for at least 16 weeks.
- •Patients who have been treated with anti-obesity medication for last 12 weeks prior to initiation of Saxenda® treatment.
- •Patients who receive GLP-1 receptor agonist for treatment of Type 2 diabetes.
- •Patients who have undergone bariatric surgery or use of minimal-invasive weight loss devices (i.e. intragastric balloons, lap bands) within 1 year before starting Saxenda® treatment.
排除标准
- 未提供
研究组 & 干预措施
Liraglutide
Participants with obesity who received initial prescription of Saxenda® (liragltuide 3.0 milligrams (mg) once daily) and maintained treatment with Saxenda® for at least 16 weeks, without treatment break, following the initial prescription for weight management.
干预措施: Liraglutide (Drug)
结局指标
主要结局
Relative change in body weight
时间窗: At 52th week after treatment initiation
Measured in Percentage (%).
次要结局
- Achievement of greater than or equal to 5% and greater than or equal to 10% weight loss(At 26th week after treatment initiation)
- Percentage of relative change in body weight(At 26th week after treatment initiation)
- Absolute body weight change(At 52th week after treatment initiation)
- Achievement of greater than or equal to 10% weight loss(At 52th week after treatment initiation)
- Mean dose of Saxenda®(At 52nd week after treatment initiation)
- Achievement of greater than or equal to 5% weight loss(At 52th week after treatment initiation)
- Participants who have discontinued Saxenda®(At 52nd week after treatment initiation)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Study to Evaluate the Safety and Effectiveness of Saxenda® for Weight Management in Routine Clinical Practice in Taiwan.ObesityNCT06283641Novo Nordisk A/S300
已完成
不适用
A Research Study About Weight Loss and Treatment Patterns With the Use of Saxenda® in Adults in Real-life Settings in SwitzerlandObesity or OverweightNCT05153590Novo Nordisk A/S269
已完成
不适用
A 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.OverweightObesityNCT03560336Novo Nordisk A/S758
进行中（未招募）
4 期
Saxenda: Underlying Mechanisms and Clinical OutcomesObesityNCT02944500Beth Israel Deaconess Medical Center28
已完成
2 期
Study to Evaluate the Effect of Lixisenatide in Patient With Parkinson's DiseaseParkinson DiseaseNCT03439943University Hospital, Toulouse156