ObesityNCT06288399
Prevalence and Economic Burden of Obesity-related Comorbidities in the Gulf Region: A Retrospective, Observational Study
An observational study of Obesity, run by Novo Nordisk A/S at 7 sites in 3 countries.
Trial summary
The aim of this study is to assess the annual prevalence of ORCs among adult people with obesity in the real-world clinical setting across the Gulf region. In addition, the study will describe the annual HCRU and associated costs of obesity and ORCs, describe the demographics and clinical characteristics of adult… 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
- 1,316 participants
- Where
- 7 sitesin 3 countries
- Study dates
- 21 Dec 2023to 30 Sep 2024
- 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: Adults with diagnosis of obesity and obesity-related comorbidities
Who may be able to join
- Local national (male or female) of Arab ethnicity, age above or equal to 18 years at index date
- Primary or secondary diagnosis of obesity (BMI above or equal to 30 kg/m2) at index date
- Minimum of 1 visit with BMI recorded between months 1 and 6 following index date, and minimum of 1 visit with BMI recorded between months 7 and 12 following index date.
- There should be a minimum time gap of 3 months between the BMI records and the BMI must be above or equal 30 kg/m2 at each visit. If there are multiple visits during the 12-month observation period, then a mean BMI above or equal 30 kg/m2 must be maintained during the observation period.
Who cannot join
- Previous participation in this study. Participation is defined as having collected data of the participants in this study already.
- Participation in an interventional trial during the 12-month observation period
- Conditions associated with unintentional weight change
- Participants who underwent bariatric surgery within 18 months prior to the index date
- Participants with non-ambulatory disability diagnosis
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
Kuwait3 sites
Farwaniya Hospital
Farwaniya, 85000
Al-Adan Hospital
Hadiya, 52700
Al-Amiri Hospital
Kuwait City, 13001
Oman2 sites
National Diabetes and Endocrine Center
Muscat, 113
Samail Polyclinic
Samail, 620
About this study
The aim of this study is to assess the annual prevalence of ORCs among adult people with obesity in the real-world clinical setting across the Gulf region. In addition, the study will describe the annual HCRU and associated costs of obesity and ORCs, describe the demographics and clinical characteristics of adult people with obesity, as well as estimate the annual incidence and point prevalence of the ORCs among adult people with obesity.
- 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 |
|---|---|---|
| Obesity Group | Adults with diagnosis of obesity and obesity-related comorbidities Receives: Other: No treatment given |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Obesity Related Comorbidities (ORC, existing/newly diagnosed) among adult people with obesity (BMI above or equal to 30 kg/m2) over a period of 12 months across the Gulf region in primary and secondary hospitals as well as obesity clinics
Percentage (and 95% CI)
ORC: Dyslipidaemia, Hypertensive diseases, Type 2 diabetes mellitus, Non-alcoholic fatty liver disease, Coronary artery disease
Measured: 12-month observation period from the index date (Day 1) to Month 12 after the index date (+12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start21 Dec 2023
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
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
- 1,316 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06288399
- Sponsor's protocol ID
- DAS-7688
- Other IDs
- U1111-1292-7248
- Status last verified
- Oct 2025
- First submitted
- 23 Feb 2024
- Last updated
- 15 Oct 2025
- 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 15 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Economic Burden of Obesity-related Comorbidities in the Gulf Region: A Retrospective, Observational Study
- ClinicalTrials.gov ID
- NCT06288399
- Acronym / sponsor ID
- DAS-7688
- Conditions
- Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,316 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 21 Dec 2023 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 1 Mar 2024 (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 aim of this study is to assess the annual prevalence of ORCs among adult people with obesity in the real-world clinical setting across the Gulf region. In addition, the study will describe the annual HCRU and associated costs of obesity and ORCs, describe the demographics and clinical characteristics of adult people with obesity, as well as estimate the annual incidence and point prevalence of the ORCs among adult people with obesity.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obesity Group | – | Other: No treatment givenAdults with diagnosis of obesity and obesity-related comorbidities |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with diagnosis of obesity and obesity-related comorbidities
Key inclusion criteria (4 listed)
- Local national (male or female) of Arab ethnicity, age above or equal to 18 years at index date
- Primary or secondary diagnosis of obesity (BMI above or equal to 30 kg/m2) at index date
- Minimum of 1 visit with BMI recorded between months 1 and 6 following index date, and minimum of 1 visit with BMI recorded between months 7 and 12 following index date.
- There should be a minimum time gap of 3 months between the BMI records and the BMI must be above or equal 30 kg/m2 at each visit. If there are multiple visits during the 12-month observation period, then a mean BMI above or equal 30 kg/m2 must be maintained during the observation period.
Key exclusion criteria (5 listed)
- Previous participation in this study. Participation is defined as having collected data of the participants in this study already.
- Participation in an interventional trial during the 12-month observation period
- Conditions associated with unintentional weight change
- Participants who underwent bariatric surgery within 18 months prior to the index date
- Participants with non-ambulatory disability diagnosis
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 | Obesity Group |
Primary outcome
Proportion of Obesity Related Comorbidities (ORC, existing/newly diagnosed) among adult people with obesity (BMI above or equal to 30 kg/m2) over a period of 12 months across the Gulf region in primary and secondary hospitals as well as obesity clinics
Time frame: 12-month observation period from the index date (Day 1) to Month 12 after the index date (+12 months)
Percentage (and 95% CI) ORC: Dyslipidaemia, Hypertensive diseases, Type 2 diabetes mellitus, Non-alcoholic fatty liver disease, Coronary artery disease
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 15 Oct 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 3 countries: 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 7 sites in 3 countries.
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 4 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: finished, as of the sponsor's last update on 15 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Kuwait, Oman, Qatar. 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?
Proportion of Obesity Related Comorbidities (ORC, existing/newly diagnosed) among adult people with obesity (BMI above or equal to 30 kg/m2) over a period of 12 months across the Gulf region in primary and secondary hospitals as well as obesity clinics (time frame: 12-month observation period from the index date (Day 1) to Month 12 after the index date (+12 months)). 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 15 Oct 2025.