A Research Study About Weight Loss and Treatment Patterns With the Use of Saxenda® in Adults in Real-life Settings in Switzerland

Study Overview
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Brief Summary
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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.

Official Title
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Weight Loss and Treatment Patterns in a Real World Population of Adults Receiving Saxenda® for Weight Management in Routine Clinical Practice in Switzerland

Conditions
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Obesity or Overweight

Intervention / Treatment
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* Drug: Saxenda®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Reimbursed<br>The reimbursed cohort includes only patients who received Saxenda® through mandatory basic insurance | Drug: Saxenda®<br>* Patients will be treated with commercially available Saxenda® according to local label and to routine clinical practice at the discretion of the treating physician. The indication is for adults who need help managing their weight based on two different body mass index (BMI) groups.<br>|
| Non reimbursed<br>The non reimbursed cohort includes patients who received Saxenda® through additional private insurance or self-pay | Drug: Saxenda®<br>* Patients will be treated with commercially available Saxenda® according to local label and to routine clinical practice at the discretion of the treating physician. The indication is for adults who need help managing their weight based on two different body mass index (BMI) groups.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Percentage of patients - yes | From Baseline (Week 0) to Week 16 | 
| 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) | Percentage of patients - yes | From Week 16 to Month 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reimbursed setting: Absolute change in body weight | messured in kg | From Baseline (Week 0) to Week 16 | 
| Reimbursed setting: Relative change in body weight | messured in percent | From Baseline (Week 0) to Week 16 | 
| Reimbursed setting: Absolute change in body weight | messured in kg | From Week 16 to Month 10 | 
| Reimbursed setting: Relative change in body weight | messured in percent | From Week 16 to Month 10 | 
| Reimbursed setting: Absolute change in body weight | messured in kg | From Baseline (Week 0) to Month 10 | 
| Reimbursed setting: Relative change in body weight | messured in percent | From Baseline (Week 0) to Month 10 | 
| Reimbursed setting: Time on Saxenda® | messured in day | From Baseline (Week 0) to end of study date | 
| Reimbursed setting: Discontinuation of patient (yes/no) | Percentage of patients - yes/no | From Baseline (Week 0) to Week 16 | 
| Reimbursed setting: Discontinuation of patient (yes/no) | Percentage of patients - yes | From Week 16 to Month 10 | 
| Reimbursed setting: Discontinuation of patient (yes/no) | Percentage of patients - yes | 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) | Percentage of patients - yes | Baseline | 
| Non-reimbursed setting: Time on Saxenda® | messured in Day | From Baseline (Week 0) to end of study date | 
| Non-reimbursed setting: Discontinuation of patient (yes/no) | Percentage of patients - yes | From Baseline (Week 0) to Week 16 | 
| Non-reimbursed setting: Discontinuation of patient (yes/no) | Percentage of patients - yes | From Week 16 to Month 10 | 
| Non-reimbursed setting:Discontinuation of patient (yes/no) | Percentage of patients - yes | From Baseline (Week 0) to Month 10 | 
| Non-reimbursed setting: Discontinuation of patient (yes/no) | Percentage of patients - yes | From Baseline (Week 0) to end of study date | 
| Non-reimbursed setting: Presence of obesity-related comorbidities identified by the authorities (pre-diabetes, type 2 diabetes, dyslipidaemia and hypertension) | Percentage of patients - yes | Baseline |