INSPIRE Turkey :A Research Study Looking at the Clinical Parameters Associated With Use and Discontinuation of Saxenda® in Local Clinical Practice in Turkey by Analysing Past Patient Medical Records
- Registration Number
- NCT05438186
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- 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.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Liraglutide 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.
- Primary Outcome Measures
Name Time Method Relative change in body weight At 52th week after treatment initiation Measured in Percentage (%).
- Secondary Outcome Measures
Name Time Method Achievement of greater than or equal to 5% and greater than or equal to 10% weight loss At 26th week after treatment initiation Measured as Count of participants.
Percentage of relative change in body weight At 26th week after treatment initiation Measured in % of weight.
Absolute body weight change At 52th week after treatment initiation Measured in kg.
Achievement of greater than or equal to 10% weight loss At 52th week after treatment initiation Measured as Count of participants.
Mean dose of Saxenda® At 52nd week after treatment initiation Measured in mg/day.
Achievement of greater than or equal to 5% weight loss At 52th week after treatment initiation Measured as Count of participants.
Participants who have discontinued Saxenda® At 52nd week after treatment initiation Measured in % of total participants.
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇹🇷Istanbul, Turkey