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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT05438186
Other study ID # NN8022-4805
Secondary ID U1111-1259-8749
Status Withdrawn
Phase
First received
Last updated
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
Health authority
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Status Withdrawn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.

Study Design


Related Conditions & MeSH terms


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
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