ObesityNCT03479762

In Market Utilisation of Liraglutide Used for Weight Management in the UK: a Study in the CPRD Primary Care Database

An observational study of Obesity and Overweight, run by Novo Nordisk A/S at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study is conducted in Europe. The aim of this study is to investigate the usage of liraglutide for weight management in clinical practice using the CPRD (Clinical Practice Research Datalink) primary care database. Read more about this study

Who is it for?: Any age
Conditions the study is for: Obesity, Overweight
What is being tested?: Liraglutide
How many people: 105 participants
Where: 1 siteDenmark
Study dates: 20 Apr 2018to 12 Sep 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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Patients in the CPRD primary care database who have been prescribed liraglutide after the UK launch of Saxenda® (and have no liraglutide prescriptions in the previous 12 months)

Who may be able to join

-New initiators of liraglutide (unbranded, or branded prescription, i.e. Saxenda® or Victoza®), who have no liraglutide prescriptions in the twelve months prior to index date (time of first prescription). Patients must be research standard (registered as "acceptable" in the database) with at least one year of up-to-standard registration prior to their index date

Who cannot join

-Not applicable

Trial locations and contacts

1 site in 1 country.

Denmark1 site

Novo Nordisk Investigational Site
Soeborg, 2860

Other trials in Denmark

About this study

Conditions: Obesity, Overweight
Being tested: Liraglutide
Medical subject headings: Obesity, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LiraglutideDrug
No treatment given

Study groups in NCT03479762
Study group	Role	What they receive
Liraglutide		Patients in the CPRD primary care database who have been prescribed liraglutide after the UK launch of Saxenda® (and have no liraglutide prescriptions in the previous 12 months) Receives: Drug: Liraglutide

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of patients with a BMI above or equal to 30 kg/m^2 (Saxenda® only)
Number
Measured: Less than 6 months before the date of the first prescription
Number of patients with a BMI above or equal to 27 kg/m^2 and below 30 kg/m^2 and 1 or more comorbidities (Saxenda® only)
With at least 1 relevant comorbidity: (Dysglycaemia, hypertension, dyslipidaemia, obstructive sleep apnoea and/or other weight related comorbidities)
Measured: Less than 6 months before the date of the first prescription
Number of patients with a BMI above or equal to 27 kg/m^2 and less than 30 kg/m^2 and no comorbidities (Saxenda® only)
None of the relevant comorbidities: (Dysglycaemia, hypertension, dyslipidaemia, obstructive sleep apnoea and/or other weight related comorbidities)
Measured: Less than 6 months before the first prescription
Number of patients with BMI below 27 kg/m^2 (Saxenda® only)
Number
Measured: Less than 6 months before the first prescription
Number of patients with less than 5% weight loss and continuing treatment (Saxenda® only)
Number
Measured: Week 0 (first prescription) to week 16; week 24
Mean weight loss in patients not treated according to stopping rule (Saxenda® only)
Measured: Week 0 (first prescription) to week 16; week 24
Number of patients with a BMI not measured (Saxenda® only)
Number
Measured: Less than 6 months before the first prescription
Number of patients with at least 5% weight loss and continuing treatment (Saxenda® only)
Number
Measured: Week 16 - week 24

Secondary outcomes (12)

Number of patients fulfilling at least one of the following: 1) a prescription interval corresponding to a daily dose of 3.0 mg, 2) dose information of 3.0 mg per day, or 3) indication of weight management (Victoza® only)
Number of patients with Victoza® prescriptions
Measured: Within 4-12 weeks from the date of the first prescription
Number of initiators with other GLP-1 receptor agonists prescribed during continued treatment with Saxenda® (Saxenda® only)
Continued treatment is defined as no gaps of more than 30 days between assumed prescription end and the subsequent prescription date
Measured: From date of first prescription until 24 months
Number of initiators with other products for weight management prescribed during continued treatment with Saxenda® (Saxenda® only)
Continued treatment is defined as no gaps of more than 30 days between assumed prescription end and the subsequent prescription date
Measured: From date of first prescription until 24 months
Number of patients who have reached 3.0 mg (Saxenda® only)
Number
Measured: 12 weeks from time of first prescription
Number of patients with a treatment duration of 0-6 months (Saxenda® only)
Number
Measured: Month 6
Number of patients with a treatment duration of 7-12 months (Saxenda® only)
Number
Measured: Month 12
Number of patients with a treatment duration of 13-18 months (Saxenda® only)
Number
Measured: Month 18
Number of patients with a treatment duration of 19-24 months (Saxenda® only)
Number
Measured: Month 24
Number of patients with a treatment duration of 25-36 months (Saxenda® only)
Number
Measured: Month 36
Number of patients with a treatment duration of 37-48 months (Saxenda® only)
Number
Measured: Month 48
Number of patients with a treatment duration of 49-60 months (Saxenda® only)
Number
Measured: Month 60
Number of patients with ongoing treatment (current users) (Saxenda® only)
Number
Measured: Month 60

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Apr 201812 Sep 2022

First posted27 Mar 2018
Study start20 Apr 2018
Primary completion12 Sep 2022
Study completion12 Sep 2022

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: 105 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03479762
Sponsor's protocol ID: NN8022-4246
Other IDs: U1111-1185-3276, EUPAS23369
Status last verified: Nov 2022
First submitted: 21 Mar 2018
Last updated: 25 Nov 2022
Results posted: No
Data monitoring committee: No
FDA-regulated device: No
Individual data sharing: Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Obesity trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: In Market Utilisation of Liraglutide Used for Weight Management in the UK: a Study in the CPRD Primary Care Database
ClinicalTrials.gov ID: NCT03479762
Acronym / sponsor ID: NN8022-4246
Conditions: Obesity, Overweight
Study type: Observational
Recruitment status: Completed
Enrolment: 105 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: 20 Apr 2018 (actual)
Primary completion: 12 Sep 2022 (actual)
Study completion: 12 Sep 2022 (actual)
First posted: 27 Mar 2018 (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.

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 1

Arm	Type	Receives
Liraglutide	–	Drug: LiraglutidePatients in the CPRD primary care database who have been prescribed liraglutide after the UK launch of Saxenda® (and have no liraglutide prescriptions in the previous 12 months)

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Patients in the CPRD primary care database who have been prescribed liraglutide after the UK launch of Saxenda® (and have no liraglutide prescriptions in the previous 12 months)

Key inclusion criteria (1 listed)

-New initiators of liraglutide (unbranded, or branded prescription, i.e. Saxenda® or Victoza®), who have no liraglutide prescriptions in the twelve months prior to index date (time of first prescription). Patients must be research standard (registered as "acceptable" in the database) with at least one year of up-to-standard registration prior to their index date

Key exclusion criteria (1 listed)

-Not applicable

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
LiraglutideNo treatment given	Drug	Liraglutide

Primary outcome

Number of patients with a BMI above or equal to 30 kg/m^2 (Saxenda® only)
Time frame: Less than 6 months before the date of the first prescription
Number
Number of patients with a BMI above or equal to 27 kg/m^2 and below 30 kg/m^2 and 1 or more comorbidities (Saxenda® only)
Time frame: Less than 6 months before the date of the first prescription
With at least 1 relevant comorbidity: (Dysglycaemia, hypertension, dyslipidaemia, obstructive sleep apnoea and/or other weight related comorbidities)
Number of patients with a BMI above or equal to 27 kg/m^2 and less than 30 kg/m^2 and no comorbidities (Saxenda® only)
Time frame: Less than 6 months before the first prescription
None of the relevant comorbidities: (Dysglycaemia, hypertension, dyslipidaemia, obstructive sleep apnoea and/or other weight related comorbidities)
Number of patients with BMI below 27 kg/m^2 (Saxenda® only)
Time frame: Less than 6 months before the first prescription
Number
Number of patients with less than 5% weight loss and continuing treatment (Saxenda® only)
Time frame: Week 0 (first prescription) to week 16; week 24
Number
Mean weight loss in patients not treated according to stopping rule (Saxenda® only)
Time frame: Week 0 (first prescription) to week 16; week 24
Number of patients with a BMI not measured (Saxenda® only)
Time frame: Less than 6 months before the first prescription
Number
Number of patients with at least 5% weight loss and continuing treatment (Saxenda® only)
Time frame: Week 16 - week 24
Number

12 secondary outcomes

Number of patients fulfilling at least one of the following: 1) a prescription interval corresponding to a daily dose of 3.0 mg, 2) dose information of 3.0 mg per day, or 3) indication of weight management (Victoza® only)
Time frame: Within 4-12 weeks from the date of the first prescription
Number of initiators with other GLP-1 receptor agonists prescribed during continued treatment with Saxenda® (Saxenda® only)
Time frame: From date of first prescription until 24 months
Number of initiators with other products for weight management prescribed during continued treatment with Saxenda® (Saxenda® only)
Time frame: From date of first prescription until 24 months
Number of patients who have reached 3.0 mg (Saxenda® only)
Time frame: 12 weeks from time of first prescription
Number of patients with a treatment duration of 0-6 months (Saxenda® only)
Time frame: Month 6
Number of patients with a treatment duration of 7-12 months (Saxenda® only)
Time frame: Month 12
Number of patients with a treatment duration of 13-18 months (Saxenda® only)
Time frame: Month 18
Number of patients with a treatment duration of 19-24 months (Saxenda® only)
Time frame: Month 24
Number of patients with a treatment duration of 25-36 months (Saxenda® only)
Time frame: Month 36
Number of patients with a treatment duration of 37-48 months (Saxenda® only)
Time frame: Month 48
Number of patients with a treatment duration of 49-60 months (Saxenda® only)
Time frame: Month 60
Number of patients with ongoing treatment (current users) (Saxenda® only)
Time frame: Month 60

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2022.
Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Related trials for Obesity

RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)

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 Reporting Office (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 and Overweight, run by Novo Nordisk A/S at 1 site in Denmark.

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 1 inclusion and 1 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: finished, as of the sponsor's last update on 25 Nov 2022. 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 Denmark. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Number of patients with a BMI above or equal to 30 kg/m^2 (Saxenda® only) (time frame: Less than 6 months before the date of the first prescription). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03479762.

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 Nov 2022.