Clinical trial NCT05438186: 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
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
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Obesity
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2022-06-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with obesity who received initial prescription of Saxenda® and maintained treatment with Saxenda® for at least 16 weeks, without treatment break, following the initial prescription for weight management.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Relative change in body weight
timeFrame: At 52th week after treatment initiation
Secondary outcomes:
measure: Percentage of relative change in body weight
timeFrame: At 16th week after treatment initiation
measure: Percentage of relative change in body weight
timeFrame: At 26th week after treatment initiation
measure: Absolute body weight change
timeFrame: At 16th week after treatment initiation
measure: Absolute body weight change
timeFrame: At 26th week after treatment initiation
measure: Absolute body weight change
timeFrame: At 52th week after treatment initiation
measure: Achievement of greater than or equal to 5% weight loss
timeFrame: At 52th week after treatment initiation
measure: Achievement of greater than or equal to 10% weight loss
timeFrame: At 52th week after treatment initiation
measure: Achievement of greater than or equal to 5% and greater than or equal to 10% weight loss
timeFrame: At 26th week after treatment initiation
measure: Mean dose of Saxenda®
timeFrame: At 16th week after treatment initiation
measure: Mean dose of Saxenda®
timeFrame: At 26th week after treatment initiation
measure: Mean dose of Saxenda®
timeFrame: At 52nd week after treatment initiation
measure: Participants who have discontinued Saxenda®
timeFrame: At 16th week after treatment initiation
measure: Participants who have discontinued Saxenda®
timeFrame: At 26th week after treatment initiation
measure: Participants who have discontinued Saxenda®
timeFrame: At 52nd week after treatment initiation
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References: