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

NCT05438186 | Withdrawn

• 2 other identifiers: NN8022-4805U1111-1259-8749
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Relative change in body weight

  Measured in Percentage (%).

  At 52th week after treatment initiation

Secondary Outcomes (14)

• Percentage of relative change in body weight

  At 16th week after treatment initiation

• Percentage of relative change in body weight

  At 26th week after treatment initiation

• Absolute body weight change

  At 16th week after treatment initiation

• Absolute body weight change

  At 26th week after treatment initiation

• Absolute body weight change

  At 52th week after treatment initiation

Study Arms (1)

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

Interventions

Liraglutide DRUG

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.

Liraglutide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Obesity

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2022
• First Posted: June 29, 2022
• Study Start: September 1, 2022
• Primary Completion: September 30, 2022
• Study Completion: October 31, 2022
• Last Updated: January 25, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)