A Research Study About Weight Loss and Treatment Patterns With the Use of Saxenda® in Adults in Real-life Settings in Switzerland
- Registration Number
- NCT05153590
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 269
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Reimbursed Saxenda® The reimbursed cohort includes only patients who received Saxenda® through mandatory basic insurance Non reimbursed Saxenda® The non reimbursed cohort includes patients who received Saxenda® through additional private insurance or self-pay
- Primary Outcome Measures
Name Time Method 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) 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) From Week 16 to Month 10 Percentage of patients - yes
- Secondary Outcome Measures
Name Time Method Reimbursed setting: Time on Saxenda® From Baseline (Week 0) to end of study date messured in day
Reimbursed setting: Discontinuation of patient (yes/no) From Baseline (Week 0) to Month 10 Percentage of patients - yes
Reimbursed setting: Presence of obesity-related comorbidities identified by authorities (*pre-diabetes, type 2 diabetes, dyslipidaemia and hypertension) Baseline Percentage of patients - yes
Non-reimbursed setting: Time on Saxenda® From Baseline (Week 0) to end of study date messured in Day
Non-reimbursed setting: Discontinuation of patient (yes/no) From Baseline (Week 0) to end of study date Percentage of patients - yes
Non-reimbursed setting:Discontinuation of patient (yes/no) From Baseline (Week 0) to Month 10 Percentage of patients - yes
Non-reimbursed setting: Presence of obesity-related comorbidities identified by the authorities (pre-diabetes, type 2 diabetes, dyslipidaemia and hypertension) Baseline Percentage of patients - yes
Reimbursed setting: Absolute change in body weight From Baseline (Week 0) to Month 10 messured in kg
Reimbursed setting: Relative change in body weight From Baseline (Week 0) to Month 10 messured in percent
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇩🇰Soeborg, Denmark