Overweight, ObesityNCT06805539
A Study Collecting Remote Data in People With an Overweight Condition or Obesity on a Weight Management Program
An observational study of Overweight, Obesity, run by Novo Nordisk A/S at 1 site in Denmark.
Trial summary
The purpose of this study is to collect health data related from participants living with an overweight condition in a decentralised clinical study set-up. All data will be collected remotely using an app downloaded on your personal smartphone and devices (watch and scale). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- No treatment given
- How many people
- 146 participants
- Where
- 1 siteDenmark
- Study dates
- 14 Apr 2025to 20 Apr 2026
- 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 an overweight condition or obesity undergoing weight management prescribed by a general practitioner
Who may be able to join
- Informed electronic consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
- Willingness to consent via the e-consent process before any study-related activities (study- related activities are any procedure related to recording of data according to the protocol)
- Male or female, age above or equal to 18 years at the time of signing informed consent
- Body mass index (BMI) above or equal to 25 kg/m^2 self-reported in the Confirmation of Eligibility Questionnaire
- About to initiate/has initiated at least one of the following weight management program(s) :
- Diet regime aimed at losing weight and/or
Show all 12Show fewer
- Exercise regime aimed at losing weight and/or
- Prescription of any approved anti-obesity medication (according to standard practice) as prescribed by the participant's treating physician
- Willingness to follow study procedures
- Willingness to, and capable of using the study devices and app
- Fluent in oral and written Danish language
- In possession of a compatible smartphone (minimum Android 10 and iOS14) throughout the study that has a reliable internet connection, regular connection to 4G/5G network, or Wi-Fi and that has the capability of downloading the study app and connecting with the smartwatch, the body composition scale and the data hub)
Who cannot join
- Previous participation in this study. Participation is defined as having given informed consent in this study
- Participation in any study investigating an overweight condition or obesity
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
- Type 1 or type 2 diabetes
- Currently under treatment with any GLP-1 RA with the indication of improving glycaemic control
- Currently using a pacemaker, an implantable cardioverter-defibrillator (ICD) or cardiac resynchronisation therapy (CRT) due to the electrical effects of the body composition scale
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an effective contraceptive method during the study duration
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Aarhus Universitetshospital, Steno Diabetes Center Aarhus
Aarhus, 8200
About this study
Official title: Decentralised Observational Disease Area Study Exploring Remote Collection of Data in Adult Participants With Overweight Condition or Obesity Undergoing Weight Management Program
The purpose of this study is to collect health data related from participants living with an overweight condition in a decentralised clinical study set-up. All data will be collected remotely using an app downloaded on your personal smartphone and devices (watch and scale).
Participants will participate in this study for 24 weeks. The study does not include any study medicine.
- Conditions
- Overweight, Obesity
- Being tested
- No treatment given
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No treatment givenOther
No treatment given
| Study group | Role | What they receive |
|---|---|---|
| Consent video | Participants watching a pre-recorded consent video. Receives: Other: No treatment given | |
| Video call | Participants obtaining the information regarding the study at a video call from the study staff. Receives: Other: No treatment given |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of the electronic informed consent process (e-consent)
Count
Measured: Week -2 to week 0
Body weight measurements recorded
Count
Measured: From week 0 (device set-up date) to the week 24 (end of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start14 Apr 2025
- Primary completion20 Apr 2026
- Study completion20 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight, 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
- Prospective
- Enrolment
- 146 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
- NCT06805539
- Sponsor's protocol ID
- NN9536-7632
- Other IDs
- U1111-1301-4301
- Status last verified
- Apr 2026
- First submitted
- 28 Jan 2025
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk committment on novonordisk-trials.com
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decentralised Observational Disease Area Study Exploring Remote Collection of Data in Adult Participants With Overweight Condition or Obesity Undergoing Weight Management Program
- ClinicalTrials.gov ID
- NCT06805539
- Acronym / sponsor ID
- NN9536-7632
- Conditions
- Overweight, Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 14 Apr 2025 (actual)
- Primary completion
- 20 Apr 2026 (actual)
- Study completion
- 20 Apr 2026 (actual)
- First posted
- 3 Feb 2025 (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 purpose of this study is to collect health data related from participants living with an overweight condition in a decentralised clinical study set-up. All data will be collected remotely using an app downloaded on your personal smartphone and devices (watch and scale).
Participants will participate in this study for 24 weeks. The study does not include any study medicine.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Consent video | – | Other: No treatment givenParticipants watching a pre-recorded consent video. |
| Video call | – | Other: No treatment givenParticipants obtaining the information regarding the study at a video call from the study staff. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with an overweight condition or obesity undergoing weight management prescribed by a general practitioner
Key inclusion criteria (12 listed)
- Informed electronic consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
- Willingness to consent via the e-consent process before any study-related activities (study- related activities are any procedure related to recording of data according to the protocol)
- Male or female, age above or equal to 18 years at the time of signing informed consent
- Body mass index (BMI) above or equal to 25 kg/m^2 self-reported in the Confirmation of Eligibility Questionnaire
- About to initiate/has initiated at least one of the following weight management program(s) :
Key exclusion criteria (7 listed)
- Previous participation in this study. Participation is defined as having given informed consent in this study
- Participation in any study investigating an overweight condition or obesity
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
- Type 1 or type 2 diabetes
- Currently under treatment with any GLP-1 RA with the indication of improving glycaemic control
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 |
|---|---|---|
| No treatment givenNo treatment given | Other | Consent video, Video call |
Primary outcome
Completion of the electronic informed consent process (e-consent)
Time frame: Week -2 to week 0
Count
Body weight measurements recorded
Time frame: From week 0 (device set-up date) to the week 24 (end of study)
Count
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 4 May 2026.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk committment 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 Overweight, Obesity, 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 12 inclusion and 7 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 4 May 2026. 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?
Completion of the electronic informed consent process (e-consent) (time frame: Week -2 to week 0). 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?
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 4 May 2026.