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

Obesity Clinical Trial

— INSPIRE Turkey  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05438186
• Other study ID #: NN8022-4805
• Secondary ID: U1111-1259-8749
• Status: Withdrawn
• Start date: September 1, 2022
• Est. completion date: October 31, 2022

Study information

• Verified date: January 2023
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 31, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Obesity

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Turkey	Novo Nordisk Investigational Site	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relative change in body weight	Measured in Percentage (%).	At 52th week after treatment initiation
Secondary	Percentage of relative change in body weight	Measured in % of weight.	At 16th week after treatment initiation
Secondary	Percentage of relative change in body weight	Measured in % of weight.	At 26th week after treatment initiation
Secondary	Absolute body weight change	Measured in kg.	At 16th week after treatment initiation
Secondary	Absolute body weight change	Measured in kg.	At 26th week after treatment initiation
Secondary	Absolute body weight change	Measured in kg.	At 52th week after treatment initiation
Secondary	Achievement of greater than or equal to 5% weight loss	Measured as Count of participants.	At 52th week after treatment initiation
Secondary	Achievement of greater than or equal to 10% weight loss	Measured as Count of participants.	At 52th week after treatment initiation
Secondary	Achievement of greater than or equal to 5% and greater than or equal to 10% weight loss	Measured as Count of participants.	At 26th week after treatment initiation
Secondary	Mean dose of Saxenda®	Measured in mg/day.	At 16th week after treatment initiation
Secondary	Mean dose of Saxenda®	Measured in mg/day.	At 26th week after treatment initiation
Secondary	Mean dose of Saxenda®	Measured in mg/day.	At 52nd week after treatment initiation
Secondary	Participants who have discontinued Saxenda®	Measured in % of total participants.	At 16th week after treatment initiation
Secondary	Participants who have discontinued Saxenda®	Measured in % of total participants.	At 26th week after treatment initiation
Secondary	Participants who have discontinued Saxenda®	Measured in % of total participants.	At 52nd week after treatment initiation