Weight Loss and Treatment Patterns in a Real World Population of Adults Receiving Saxenda® for Weight Management in Routine Clinical Practice in Switzerland
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 269
- 试验地点
- 1
- 主要终点
- Relative change in body weight greater than or equal to 5% (lower BMI with weight related comorbidities) or greater than or equal to 7% (higher BMI) in reimbursed setting (yes/no)
研究概览
简要总结
The study is investigating weight loss and treatment patterns associated with the use of Saxenda® in adult patients.
The aim of the study is to assess the weight loss associated with Saxenda® in patients with obesity or overweight. Saxenda® was prescribed to participants by study doctor independently of this study.
The study will last for about 4 months, where the data will be collected from the available medical records.
There will be no additional activities expected from participants in the scope of study because it is a chart-review study.
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 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed consent (general consent for research or study-specific informed consent) obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
- •Male or female, aged 18 to 74 years (both inclusive) at the time of Saxenda® initiation.
- •Have been prescribed Saxenda® for weight management.
- •For the reimbursed cohort, per the Swiss reimbursement criteria: BMI greater than or equal to 35 kg/m^2 or a BMIgreater than or equal to 28 and below 35 kg/m^2 with additional weight related comorbidities (pre diabetes or T2D (Type 2 Diabetes Mellitus), hypertension, dyslipidaemia), prior to receiving the Saxenda® treatment.
- •For the non-reimbursed cohort, BMI greater than or equal to 30 kg/m^2 or a BMI greater than or equal to 28 kg/m^2 with additional weight related comorbidities (pre diabetes or T2D, arterial hypertension, dyslipidaemia), prior to receiving the Saxenda® treatment.
- •The decision to initiate treatment with commercially available Saxenda® 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.
- •Baseline weight measurement within 3 months of Saxenda® initiation/prescription.
- •At least one weight assessment post-Saxenda® initiation/prescription.
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 of Saxenda® prescription/initiation.
- •Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
- •Concomitant treatment of Saxenda® with other GLP 1 (Glucagon-like peptide-1) receptor agonists, or orlistat.
- •Concomitant treatment with sodium/glucose cotransporter-2 inhibitors (SGLT 2i), dipeptidyl peptidase-4 (DPP 4i), or insulin for the reimbursed cohort only.
- •Patients who have been treated with any obesity medication for last 12 weeks prior to initiation of Saxenda® treatment.
- •Patients who have previously been treated with a GLP 1 receptor agonist for the reimbursed cohort only.
- •Patients who have undergone bariatric surgery at any time before starting Saxenda® treatment.
- •Patients initiating Saxenda® treatment after 31 October 2020.
研究组 & 干预措施
Reimbursed
The reimbursed cohort includes only patients who received Saxenda® through mandatory basic insurance
干预措施: Saxenda® (Drug)
Non reimbursed
The non reimbursed cohort includes patients who received Saxenda® through additional private insurance or self-pay
干预措施: Saxenda® (Drug)
结局指标
主要结局
Relative change in body weight greater than or equal to 5% (lower BMI with weight related comorbidities) or greater than or equal to 7% (higher BMI) in reimbursed setting (yes/no)
时间窗: From Baseline (Week 0) to Week 16
Percentage of patients - yes
Relative change in body weight greater than or equal to 5%, conditionally to relative change greater than or equal to 5% or greater than or equal to 7% at Week 16 in reimbursed setting(yes/no)
时间窗: From Week 16 to Month 10
Percentage of patients - yes
次要结局
- Reimbursed setting: Time on Saxenda®(From Baseline (Week 0) to end of study date)
- Reimbursed setting: Discontinuation of patient (yes/no)(From Baseline (Week 0) to Month 10)
- Reimbursed setting: Presence of obesity-related comorbidities identified by authorities (*pre-diabetes, type 2 diabetes, dyslipidaemia and hypertension)(Baseline)
- Non-reimbursed setting: Time on Saxenda®(From Baseline (Week 0) to end of study date)
- Non-reimbursed setting: Discontinuation of patient (yes/no)(From Baseline (Week 0) to end of study date)
- Non-reimbursed setting:Discontinuation of patient (yes/no)(From Baseline (Week 0) to Month 10)
- Non-reimbursed setting: Presence of obesity-related comorbidities identified by the authorities (pre-diabetes, type 2 diabetes, dyslipidaemia and hypertension)(Baseline)
- Reimbursed setting: Absolute change in body weight(From Baseline (Week 0) to Month 10)
- Reimbursed setting: Relative change in body weight(From Baseline (Week 0) to Month 10)