ObesityINSPIRE TurkeyNCT05438186
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
An observational study of Obesity, run by Novo Nordisk A/S at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Liraglutide
- How many people
- 0 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2022to 31 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Liraglutide
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiraglutideDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Liraglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative change in body weight
Measured in Percentage (%).
Measured: At 52th week after treatment initiation
Secondary outcomes (14)
Percentage of relative change in body weight
Measured in % of weight.
Measured: At 16th week after treatment initiation
Percentage of relative change in body weight
Measured in % of weight.
Measured: At 26th week after treatment initiation
Absolute body weight change
Measured in kg.
Measured: At 16th week after treatment initiation
Absolute body weight change
Measured in kg.
Measured: At 26th week after treatment initiation
Absolute body weight change
Measured in kg.
Measured: At 52th week after treatment initiation
Achievement of greater than or equal to 5% weight loss
Measured as Count of participants.
Measured: At 52th week after treatment initiation
Achievement of greater than or equal to 10% weight loss
Measured as Count of participants.
Measured: 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.
Measured: At 26th week after treatment initiation
Mean dose of Saxenda®
Measured in mg/day.
Measured: At 16th week after treatment initiation
Mean dose of Saxenda®
Measured in mg/day.
Measured: At 26th week after treatment initiation
Mean dose of Saxenda®
Measured in mg/day.
Measured: At 52nd week after treatment initiation
Participants who have discontinued Saxenda®
Measured in % of total participants.
Measured: At 16th week after treatment initiation
Participants who have discontinued Saxenda®
Measured in % of total participants.
Measured: At 26th week after treatment initiation
Participants who have discontinued Saxenda®
Measured in % of total participants.
Measured: At 52nd week after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start1 Sep 2022 (estimated)
- Primary completion30 Sep 2022 (estimated)
- Study completion31 Oct 2022 (estimated)
Why it stopped: No participants enrolled since study start.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05438186
- Sponsor's protocol ID
- NN8022-4805
- Other IDs
- U1111-1259-8749
- Acronym
- INSPIRE Turkey
- Status last verified
- Jan 2023
- First submitted
- 24 Jun 2022
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05438186
- Acronym / sponsor ID
- INSPIRE Turkey / NN8022-4805
- Conditions
- Obesity
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No participants enrolled since study start.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 31 Oct 2022 (estimated)
- First posted
- 29 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liraglutide | – | Drug: LiraglutideParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LiraglutideParticipants 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 |
Primary outcome
Relative change in body weight
Time frame: At 52th week after treatment initiation
Measured in Percentage (%).
14 secondary outcomes
Percentage of relative change in body weight
Time frame: At 16th week after treatment initiation
Percentage of relative change in body weight
Time frame: At 26th week after treatment initiation
Absolute body weight change
Time frame: At 16th week after treatment initiation
Absolute body weight change
Time frame: At 26th week after treatment initiation
Absolute body weight change
Time frame: At 52th week after treatment initiation
Achievement of greater than or equal to 5% weight loss
Time frame: At 52th week after treatment initiation
Achievement of greater than or equal to 10% weight loss
Time frame: At 52th week after treatment initiation
Achievement of greater than or equal to 5% and greater than or equal to 10% weight loss
Time frame: At 26th week after treatment initiation
Mean dose of Saxenda®
Time frame: At 16th week after treatment initiation
Mean dose of Saxenda®
Time frame: At 26th week after treatment initiation
Mean dose of Saxenda®
Time frame: At 52nd week after treatment initiation
Participants who have discontinued Saxenda®
Time frame: At 16th week after treatment initiation
Participants who have discontinued Saxenda®
Time frame: At 26th week after treatment initiation
Participants who have discontinued Saxenda®
Time frame: At 52nd week after treatment initiation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Transparency (dept. 2834) study director
Novo Nordisk A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Novo Nordisk A/S at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative change in body weight (time frame: At 52th week after treatment initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2023.