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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

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

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05438186
Acronym
INSPIRE Turkey
Enrollment
0
Registered
2022-06-29
Start date
2022-09-01
Completion date
2022-10-31
Last updated
2023-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

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.

Interventions

DRUGLiraglutide

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.

Sponsors

Novo Nordisk A/S
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Relative change in body weightAt 52th week after treatment initiationMeasured in Percentage (%).

Secondary

MeasureTime frameDescription
Absolute body weight changeAt 16th week after treatment initiationMeasured in kg.
Achievement of greater than or equal to 5% weight lossAt 52th week after treatment initiationMeasured as Count of participants.
Achievement of greater than or equal to 10% weight lossAt 52th week after treatment initiationMeasured as Count of participants.
Percentage of relative change in body weightAt 16th week after treatment initiationMeasured in % of weight.
Mean dose of Saxenda®At 16th week after treatment initiationMeasured in mg/day.
Participants who have discontinued Saxenda®At 16th week after treatment initiationMeasured in % of total participants.
Achievement of greater than or equal to 5% and greater than or equal to 10% weight lossAt 26th week after treatment initiationMeasured as Count of participants.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026