Obesity or OverweightNCT05153590

A Research Study About Weight Loss and Treatment Patterns With the Use of Saxenda® in Adults in Real-life Settings in Switzerland

An observational study of Obesity or 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

The study is investigating weight loss and treatment patterns associated with the use of Saxenda® in adult patients. The aim of the study is to assess the weight loss associated with Saxenda® in patients with obesity or overweight. Saxenda® was prescribed to participants by study doctor independently of this study. Read more about this study

Who is it for?: Ages 18 to 74 years
Conditions the study is for: Obesity or Overweight
What is being tested?: Saxenda®
How many people: 269 participants
Where: 1 siteDenmark
Study dates: 3 Dec 2021to 15 Apr 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 to 74 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: The study population will consist of male or female adults who have been prescribed Saxenda® for weight management in 2 cohorts reimbursed and non reimbursed

Who may be able to join

Signed consent (general consent for research or study-specific informed consent) obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
Male or female, aged 18 to 74 years (both inclusive) at the time of Saxenda® initiation.
Have been prescribed Saxenda® for weight management.
For the reimbursed cohort, per the Swiss reimbursement criteria: BMI greater than or equal to 35 kg/m^2 or a BMIgreater than or equal to 28 and below 35 kg/m^2 with additional weight related comorbidities (pre diabetes or T2D (Type 2 Diabetes Mellitus), hypertension, dyslipidaemia), prior to receiving the Saxenda® treatment.
For the non-reimbursed cohort, BMI greater than or equal to 30 kg/m^2 or a BMI greater than or equal to 28 kg/m^2 with additional weight related comorbidities (pre diabetes or T2D, arterial hypertension, dyslipidaemia), prior to receiving the Saxenda® treatment.
The decision to initiate treatment with commercially available Saxenda® has been made by the patient/legally acceptable representative (LAR) and the treating physician before and independently from the decision to include the patient in this study.
Baseline weight measurement within 3 months of Saxenda® initiation/prescription.
At least one weight assessment post-Saxenda® initiation/prescription.

Who cannot join

Previous participation in this study. Participation is defined as having given informed consent in this study.
Treatment with any investigational drug within 30 days of Saxenda® prescription/initiation.
Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
Concomitant treatment of Saxenda® with other GLP 1 (Glucagon-like peptide-1) receptor agonists, or orlistat.
Concomitant treatment with sodium/glucose cotransporter-2 inhibitors (SGLT 2i), dipeptidyl peptidase-4 (DPP 4i), or insulin for the reimbursed cohort only.
Patients who have been treated with any obesity medication for last 12 weeks prior to initiation of Saxenda® treatment.

Show all 9Show fewer

Patients who have previously been treated with a GLP 1 receptor agonist for the reimbursed cohort only.
Patients who have undergone bariatric surgery at any time before starting Saxenda® treatment.
Patients initiating Saxenda® treatment after 31 October 2020.

Trial locations and contacts

1 site in 1 country.

Denmark1 site

Novo Nordisk Investigational Site
Soeborg, 2860

Other trials in Denmark

About this study

Official title: Weight Loss and Treatment Patterns in a Real World Population of Adults Receiving Saxenda® for Weight Management in Routine Clinical Practice in Switzerland

The study is investigating weight loss and treatment patterns associated with the use of Saxenda® in adult patients.

The aim of the study is to assess the weight loss associated with Saxenda® in patients with obesity or overweight. Saxenda® was prescribed to participants by study doctor independently of this study.

The study will last for about 4 months, where the data will be collected from the available medical records.

There will be no additional activities expected from participants in the scope of study because it is a chart-review study.

Conditions: Obesity or Overweight
Being tested: Saxenda®
Medical subject headings: Obesity, Overweight

What participants receive

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

Saxenda®Drug
Patients will be treated with commercially available Saxenda® according to local label and to routine clinical practice at the discretion of the treating physician.
The indication is for adults who need help managing their weight based on two different body mass index (BMI) groups.

Study groups in NCT05153590
Study group	Role	What they receive
Reimbursed		The reimbursed cohort includes only patients who received Saxenda® through mandatory basic insurance Receives: Drug: Saxenda®
Non reimbursed		The non reimbursed cohort includes patients who received Saxenda® through additional private insurance or self-pay Receives: Drug: Saxenda®

What is being measured

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

Relative change in body weight greater than or equal to 5% (lower BMI with weight related comorbidities) or greater than or equal to 7% (higher BMI) in reimbursed setting (yes/no)
Percentage of patients - yes
Measured: From Baseline (Week 0) to Week 16
Relative change in body weight greater than or equal to 5%, conditionally to relative change greater than or equal to 5% or greater than or equal to 7% at Week 16 in reimbursed setting(yes/no)
Percentage of patients - yes
Measured: From Week 16 to Month 10

Secondary outcomes (17)

Reimbursed setting: Absolute change in body weight
messured in kg
Measured: From Baseline (Week 0) to Week 16
Reimbursed setting: Relative change in body weight
messured in percent
Measured: From Baseline (Week 0) to Week 16
Reimbursed setting: Absolute change in body weight
messured in kg
Measured: From Week 16 to Month 10
Reimbursed setting: Relative change in body weight
messured in percent
Measured: From Week 16 to Month 10
Reimbursed setting: Absolute change in body weight
messured in kg
Measured: From Baseline (Week 0) to Month 10
Reimbursed setting: Relative change in body weight
messured in percent
Measured: From Baseline (Week 0) to Month 10
Reimbursed setting: Time on Saxenda®
messured in day
Measured: From Baseline (Week 0) to end of study date
Reimbursed setting: Discontinuation of patient (yes/no)
Percentage of patients - yes/no
Measured: From Baseline (Week 0) to Week 16
Reimbursed setting: Discontinuation of patient (yes/no)
Percentage of patients - yes
Measured: From Week 16 to Month 10
Reimbursed setting: Discontinuation of patient (yes/no)
Percentage of patients - yes
Measured: From Baseline (Week 0) to Month 10
Reimbursed setting: Presence of obesity-related comorbidities identified by authorities (*pre-diabetes, type 2 diabetes, dyslipidaemia and hypertension)
Percentage of patients - yes
Measured: Baseline
Non-reimbursed setting: Time on Saxenda®
messured in Day
Measured: From Baseline (Week 0) to end of study date
Non-reimbursed setting: Discontinuation of patient (yes/no)
Percentage of patients - yes
Measured: From Baseline (Week 0) to Week 16
Non-reimbursed setting: Discontinuation of patient (yes/no)
Percentage of patients - yes
Measured: From Week 16 to Month 10
Non-reimbursed setting:Discontinuation of patient (yes/no)
Percentage of patients - yes
Measured: From Baseline (Week 0) to Month 10
Non-reimbursed setting: Discontinuation of patient (yes/no)
Percentage of patients - yes
Measured: From Baseline (Week 0) to end of study date
Non-reimbursed setting: Presence of obesity-related comorbidities identified by the authorities (pre-diabetes, type 2 diabetes, dyslipidaemia and hypertension)
Percentage of patients - yes
Measured: Baseline

Timeline

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

3 Dec 202115 Apr 2022

First posted10 Dec 2021
Study start3 Dec 2021
Primary completion15 Apr 2022
Study completion15 Apr 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Obesity or OverweightStudies 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: 269 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05153590
Sponsor's protocol ID: NN8022-4823
Other IDs: U1111-1263-5715
Status last verified: Sep 2022
First submitted: 30 Nov 2021
Last updated: 17 Nov 2022
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

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 or Overweight trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Weight Loss and Treatment Patterns in a Real World Population of Adults Receiving Saxenda® for Weight Management in Routine Clinical Practice in Switzerland
ClinicalTrials.gov ID: NCT05153590
Acronym / sponsor ID: NN8022-4823
Conditions: Obesity or Overweight
Study type: Observational
Recruitment status: Completed
Enrolment: 269 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: 3 Dec 2021 (actual)
Primary completion: 15 Apr 2022 (actual)
Study completion: 15 Apr 2022 (actual)
First posted: 10 Dec 2021 (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 weight loss and treatment patterns associated with the use of Saxenda® in adult patients.

The study will last for about 4 months, where the data will be collected from the available medical records.

There will be no additional activities expected from participants in the scope of study because it is a chart-review study.

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
Reimbursed	–	Drug: Saxenda®The reimbursed cohort includes only patients who received Saxenda® through mandatory basic insurance
Non reimbursed	–	Drug: Saxenda®The non reimbursed cohort includes patients who received Saxenda® through additional private insurance or self-pay

Who may qualify

Ages: 18 to 74 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: The study population will consist of male or female adults who have been prescribed Saxenda® for weight management in 2 cohorts reimbursed and non reimbursed

Key inclusion criteria (8 listed)

Signed consent (general consent for research or study-specific informed consent) obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
Male or female, aged 18 to 74 years (both inclusive) at the time of Saxenda® initiation.
Have been prescribed Saxenda® for weight management.
For the reimbursed cohort, per the Swiss reimbursement criteria: BMI greater than or equal to 35 kg/m^2 or a BMIgreater than or equal to 28 and below 35 kg/m^2 with additional weight related comorbidities (pre diabetes or T2D (Type 2 Diabetes Mellitus), hypertension, dyslipidaemia), prior to receiving the Saxenda® treatment.
For the non-reimbursed cohort, BMI greater than or equal to 30 kg/m^2 or a BMI greater than or equal to 28 kg/m^2 with additional weight related comorbidities (pre diabetes or T2D, arterial hypertension, dyslipidaemia), prior to receiving the Saxenda® treatment.

Key exclusion criteria (9 listed)

Previous participation in this study. Participation is defined as having given informed consent in this study.
Treatment with any investigational drug within 30 days of Saxenda® prescription/initiation.
Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
Concomitant treatment of Saxenda® with other GLP 1 (Glucagon-like peptide-1) receptor agonists, or orlistat.
Concomitant treatment with sodium/glucose cotransporter-2 inhibitors (SGLT 2i), dipeptidyl peptidase-4 (DPP 4i), or insulin for the reimbursed cohort only.

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
Saxenda®Patients will be treated with commercially available Saxenda® according to local label and to routine clinical practice at the discretion of the treating physician. The indication is for adults who need help managing their weight based on two different body mass index (BMI) groups.	Drug	Non reimbursed, Reimbursed

Primary outcome

Relative change in body weight greater than or equal to 5% (lower BMI with weight related comorbidities) or greater than or equal to 7% (higher BMI) in reimbursed setting (yes/no)
Time frame: From Baseline (Week 0) to Week 16
Percentage of patients - yes
Relative change in body weight greater than or equal to 5%, conditionally to relative change greater than or equal to 5% or greater than or equal to 7% at Week 16 in reimbursed setting(yes/no)
Time frame: From Week 16 to Month 10
Percentage of patients - yes

17 secondary outcomes

Reimbursed setting: Absolute change in body weight
Time frame: From Baseline (Week 0) to Week 16
Reimbursed setting: Relative change in body weight
Time frame: From Baseline (Week 0) to Week 16
Reimbursed setting: Absolute change in body weight
Time frame: From Week 16 to Month 10
Reimbursed setting: Relative change in body weight
Time frame: From Week 16 to Month 10
Reimbursed setting: Absolute change in body weight
Time frame: From Baseline (Week 0) to Month 10
Reimbursed setting: Relative change in body weight
Time frame: From Baseline (Week 0) to Month 10
Reimbursed setting: Time on Saxenda®
Time frame: From Baseline (Week 0) to end of study date
Reimbursed setting: Discontinuation of patient (yes/no)
Time frame: From Baseline (Week 0) to Week 16
Reimbursed setting: Discontinuation of patient (yes/no)
Time frame: From Week 16 to Month 10
Reimbursed setting: Discontinuation of patient (yes/no)
Time frame: From Baseline (Week 0) to Month 10
Reimbursed setting: Presence of obesity-related comorbidities identified by authorities (*pre-diabetes, type 2 diabetes, dyslipidaemia and hypertension)
Time frame: Baseline
Non-reimbursed setting: Time on Saxenda®
Time frame: From Baseline (Week 0) to end of study date
Non-reimbursed setting: Discontinuation of patient (yes/no)
Time frame: From Baseline (Week 0) to Week 16
Non-reimbursed setting: Discontinuation of patient (yes/no)
Time frame: From Week 16 to Month 10
Non-reimbursed setting:Discontinuation of patient (yes/no)
Time frame: From Baseline (Week 0) to Month 10
Non-reimbursed setting: Discontinuation of patient (yes/no)
Time frame: From Baseline (Week 0) to end of study date
Non-reimbursed setting: Presence of obesity-related comorbidities identified by the authorities (pre-diabetes, type 2 diabetes, dyslipidaemia and hypertension)
Time frame: Baseline

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 17 Nov 2022.
Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Related trials for Obesity or Overweight

RecruitingPhase 3
Maridebart Cafraglutide in Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity
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A Study of Safety of SUN-0864 and How it is Processed by and Affects the Body in Healthy Adults and Healthy Adults Who Are Overweight or Obese.
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Active, not recruitingPhase 3
Evaluating the Impact of Maridebart Cafraglutide on Cardiovascular Outcomes in Participants With Atherosclerotic Cardiovascular Disease and Overweight or Obesity
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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. 1452) 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 or 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 8 inclusion and 9 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 17 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?

Relative change in body weight greater than or equal to 5% (lower BMI with weight related comorbidities) or greater than or equal to 7% (higher BMI) in reimbursed setting (yes/no) (time frame: From Baseline (Week 0) to Week 16). The study lists 2 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 NCT05153590.

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 17 Nov 2022.