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 (INSPIRE Turkey)

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Obesity
• Intervention / Treatment: Drug: Liraglutide

• Study Type: Observational

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relative change in body weight	Measured in Percentage (%).	At 52th week after treatment initiation

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): September 30, 2022
• Study Completion (Anticipated): October 31, 2022

Study Registration Dates

• First Submitted: June 24, 2022
• First Submitted That Met QC Criteria: June 24, 2022
• First Posted (Actual): June 29, 2022

Study Record Updates

• Last Update Posted (Estimate): January 24, 2023
• Last Update Submitted That Met QC Criteria: January 23, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Incretins; Liraglutide
• Other Study ID Numbers: NN8022-4805; U1111-1259-8749 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No