ObesityExplorEUEastNCT05795166
A Study to Understand the Distribution of Obesity Classes and Obesity Related Diseases in People With Obesity Across Countries in Czech Republic, Hungary and Poland
An observational study of Obesity, run by Novo Nordisk A/S.
Trial summary
The study is intended to understand the distribution of different obesity classes and obesity related diseases (diseases that present along with obesity) in patients with body mass index (BMI) ≥ 30 kg/m^2. Participants will be asked to give information about their health. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- No treatment given
- How many people
- 1,241 participants
- Where
- No sites listed yet
- Study dates
- 27 Apr 2023to 30 Nov 2023
- 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
- Adult, Older adult
Study population: Patients with obesity coming into the clinic as part of routine visit to their treating physician/general practitioner
Who may be able to join
- Signed 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, age greater than or equal to 18 years at the time of inclusion/enrolment in the study.
- BMI greater than or equal to 30 Kg/m^2 as measured at the inclusion in the study
Who cannot join
- Previous participation in this study. Participation is defined as having given informed consent in this study.
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation as judged by physician.
About this study
Official title: A Multicentre, Observational Study to Understand the Distribution of Obesity Classes and Obesity Related Comorbidities (ORCs) in People With Obesity Within a Real World Population in Czech Republic, Hungary and Poland
The study is intended to understand the distribution of different obesity classes and obesity related diseases (diseases that present along with obesity) in patients with body mass index (BMI) ≥ 30 kg/m^2.
Participants will be asked to give information about their health. They will continue their normal way of life and will not get any medication or additional medical test other than those prescribed to you by their doctor. Participation in the study will last for about 1 day.
- Conditions
- Obesity
- Being tested
- No treatment given
- Medical subject headings
- 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 |
|---|---|---|
| People with obesity | Patients with obesity coming into the clinic as part of routine visit to their treating physician/general practitioner Receives: Other: No treatment given |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with at least one obesity related comorbidity of interest for obesity classes I, II and III pooled across all countries
% patients with obesity
Measured: At the time of enrolment (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start27 Apr 2023
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
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
- Cross-sectional
- Enrolment
- 1,241 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
- NCT05795166
- Sponsor's protocol ID
- DAS-7530
- Other IDs
- U1111-1277-8275
- Acronym
- ExplorEUEast
- Status last verified
- Sep 2024
- First submitted
- 21 Mar 2023
- Last updated
- 19 Sep 2024
- 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
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Observational Study to Understand the Distribution of Obesity Classes and Obesity Related Comorbidities (ORCs) in People With Obesity Within a Real World Population in Czech Republic, Hungary and Poland
- ClinicalTrials.gov ID
- NCT05795166
- Acronym / sponsor ID
- ExplorEUEast / DAS-7530
- Conditions
- Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,241 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 27 Apr 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 3 Apr 2023 (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 intended to understand the distribution of different obesity classes and obesity related diseases (diseases that present along with obesity) in patients with body mass index (BMI) ≥ 30 kg/m^2.
Participants will be asked to give information about their health. They will continue their normal way of life and will not get any medication or additional medical test other than those prescribed to you by their doctor. Participation in the study will last for about 1 day.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| People with obesity | – | Other: No treatment givenPatients with obesity coming into the clinic as part of routine visit to their treating physician/general practitioner |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with obesity coming into the clinic as part of routine visit to their treating physician/general practitioner
Key inclusion criteria (3 listed)
- Signed 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, age greater than or equal to 18 years at the time of inclusion/enrolment in the study.
- BMI greater than or equal to 30 Kg/m^2 as measured at the inclusion in the study
Key exclusion criteria (2 listed)
- Previous participation in this study. Participation is defined as having given informed consent in this study.
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation as judged by physician.
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 | People with obesity |
Primary outcome
Percentage of patients with at least one obesity related comorbidity of interest for obesity classes I, II and III pooled across all countries
Time frame: At the time of enrolment (Day 1)
% patients with obesity
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 19 Sep 2024.
- 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
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Novo Nordisk A/S.
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 3 inclusion and 2 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Percentage of patients with at least one obesity related comorbidity of interest for obesity classes I, II and III pooled across all countries (time frame: At the time of enrolment (Day 1)). 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 19 Sep 2024.