ObesityCOPENCT07358052
Current Status of Cardiovascular Diseases in Chinese Overweight/ Obesity Population: An Epidemiological Study (COPE）
An observational study of Obesity and Overweight, run by Novo Nordisk A/S at 2 sites in China.
Trial summary
This study is testing how overweight and obesity affect cardiovascular disease (CVD) prevalence, risk factors, and mortality among Chinese adults using nationally representative CCDRFS (China Chronic Disease and Risk Factor Surveillance) data. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- No treatment given
- How many people
- 551,931 participants
- Where
- 2 sitesChina
- Study dates
- 8 Dec 2025to 12 Dec 2025
- 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: The subjects in this study are permanent residents aged 18 years and older who participated in the CCDRFS in 2013, 2018, and 2023. Eligible participants were permanent residents (residing ≥6 months) of the survey sites, which included 298 counties/districts across all 31 provinces, autonomous regions, and municipalities of mainland China.
Who may be able to join
- Signed 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 above or equal to 18 years at the time of signing informed consent.
- Permanent residents (residing in the survey counties/cities/districts for ≥6 months) from the 2013, 2018, and 2023 CCDRFS surveys; With complete information from physical examinations, blood biochemical tests, and questionnaires, including:
- Demographic information (age, sex, urban/rural classification, etc.);
- Height, weight, waist circumference, blood pressure;
- Blood biochemical indicators (fasting/2-hour postprandial blood glucose, glycated hemoglobin, lipid panel: high density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglycerides, total cholesterol, serum creatinine, etc.);
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- Routine urine indicators: urine protein (or urine microalbumin); self-reported prevalence of CVD and major chronic diseases (e.g., hypertension, diabetes, dyslipidemia, etc.);
- Major behavioral risk factors (smoking, alcohol consumption, physical activity, dietary patterns, etc.);
- Information on concomitant medication use.
Who cannot join
- Exclusion criteria include missing core baseline or follow-up data relevant to each part. The medical conditions under investigation include overweight and obesity, along with their comorbidity with CVD and associated risk factors.
Trial locations and contacts
2 sites in 1 country.
China2 sites
National Center for Chronic and Noncommunicable Disease Control and Prevention, Chinese CDC
Beijing, Beijing Municipality, 102206
Novonordisk Facility
Beijing
About this study
This study is testing how overweight and obesity affect cardiovascular disease (CVD) prevalence, risk factors, and mortality among Chinese adults using nationally representative CCDRFS (China Chronic Disease and Risk Factor Surveillance) data. The purpose of the study is to characterize trends and determinants of CVD in adults with overweight or obesity and to quantify the excess mortality and population burden attributable to overweight/obesity. Participants will not receive any study medicine as this is an observational analysis of existing survey and mortality data. The study does not involve a new investigational drug; it analyses health and outcome data collected in routine practice and national surveys. The study will last for the duration needed to analyse the CCDRFS datasets and linked mortality follow-up.
- Conditions
- Obesity, Overweight
- Being tested
- No treatment given
- Medical subject headings
- Obesity, Overweight
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 |
|---|---|---|
| Part 1 | Using CCDRFS data from 2013, 2018, and 2023, we will examine trends in CVD and key risk factors (hypertension, dyslipidemia, hyperglycemia, CKD) among overweight/obese adults, comparing prevalence by sex, urban/rural residence, and age to assess the impact of overweight/obesity on cardiovascular health for public health planning. Receives: Other: No treatment given | |
| Part 2 | Using CCDRFS 2023 data, we will perform a cross-sectional analysis to identify CVD risk factors in overweight and obese Chinese adults. We will: (1) compare characteristics of overweight/obese individuals with and without CVD, and (2) compare CVD patients who are overweight/obese versus normal weight. Odds ratios will be estimated to assess associations between risk factors and CVD within the overweight/obese group and to compare these associations against the normal-weight group. Subgroup and sensitivity analyses will be conducted to examine heterogeneity and robustness. Receives: Other: No treatment given | |
| Part 3 | We will link CCDRFS baseline data from 2013 and 2018 to the 2023 mortality follow-up database to estimate all-cause and cardiovascular mortality, population attributable fractions (PAF), and years of life lost (YLL) associated with overweight/obesity using Cox proportional hazards models. Receives: Other: No treatment given |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary End point
Primary outcome: prevalence of cardiovascular disease (CVD), defined as the proportion of participants reporting a physician diagnosis or self-reported history of coronary heart disease, stroke, heart failure, or peripheral artery disease. We will summarize how common CVD and related conditions are in the study population. Categorical variables (e.g., overweight/obesity, central obesity, prior diagnoses) will be reported as counts and percentages. Continuous variables (e.g., BMI, waist circumference) will be reported as n, mean, and SD. For each survey year (2013, 2018, 2023) we will compute crude and age-standardized, population-weighted prevalence estimates. Trends over time will be assessed using Joinpoint regression to estimate the Average Annual Percent Change (AAPC) with 95% confidence intervals.
Measured: 2013-2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start8 Dec 2025
- Primary completion12 Dec 2025
- Study completion12 Dec 2025
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
- 551,931 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
- NCT07358052
- Sponsor's protocol ID
- DAS-8633
- Other IDs
- U1111-1325-5282
- Acronym
- COPE
- Status last verified
- Jan 2026
- First submitted
- 24 Nov 2025
- Last updated
- 22 Jan 2026
- 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 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Current Status of Cardiovascular Diseases in Chinese Overweight/ Obesity Population: An Epidemiological Study (COPE）
- ClinicalTrials.gov ID
- NCT07358052
- Acronym / sponsor ID
- COPE / DAS-8633
- Conditions
- Obesity, Overweight
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 551,931 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 8 Dec 2025 (actual)
- Primary completion
- 12 Dec 2025 (actual)
- Study completion
- 12 Dec 2025 (actual)
- First posted
- 22 Jan 2026 (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.
This study is testing how overweight and obesity affect cardiovascular disease (CVD) prevalence, risk factors, and mortality among Chinese adults using nationally representative CCDRFS (China Chronic Disease and Risk Factor Surveillance) data. The purpose of the study is to characterize trends and determinants of CVD in adults with overweight or obesity and to quantify the excess mortality and population burden attributable to overweight/obesity. Participants will not receive any study medicine as this is an observational analysis of existing survey and mortality data. The study does not involve a new investigational drug; it analyses health and outcome data collected in routine practice and national surveys. The study will last for the duration needed to analyse the CCDRFS datasets and linked mortality follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1 | – | Other: No treatment givenUsing CCDRFS data from 2013, 2018, and 2023, we will examine trends in CVD and key risk factors (hypertension, dyslipidemia, hyperglycemia, CKD) among overweight/obese adults, comparing prevalence by sex, urban/rural residence, and age to assess the impact of overweight/obesity on cardiovascular health for public health planning. |
| Part 2 | – | Other: No treatment givenUsing CCDRFS 2023 data, we will perform a cross-sectional analysis to identify CVD risk factors in overweight and obese Chinese adults. We will: (1) compare characteristics of overweight/obese individuals with and without CVD, and (2) compare CVD patients who are overweight/obese versus normal weight. Odds ratios will be estimated to assess associations between risk factors and CVD within the overweight/obese group and to compare these associations against the normal-weight group. Subgroup and sensitivity analyses will be conducted to examine heterogeneity and robustness. |
| Part 3 | – | Other: No treatment givenWe will link CCDRFS baseline data from 2013 and 2018 to the 2023 mortality follow-up database to estimate all-cause and cardiovascular mortality, population attributable fractions (PAF), and years of life lost (YLL) associated with overweight/obesity using Cox proportional hazards models. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The subjects in this study are permanent residents aged 18 years and older who participated in the CCDRFS in 2013, 2018, and 2023. Eligible participants were permanent residents (residing ≥6 months) of the survey sites, which included 298 counties/districts across all 31 provinces, autonomous regions, and municipalities of mainland China.
Key inclusion criteria (9 listed)
- Signed 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 above or equal to 18 years at the time of signing informed consent.
- Permanent residents (residing in the survey counties/cities/districts for ≥6 months) from the 2013, 2018, and 2023 CCDRFS surveys; With complete information from physical examinations, blood biochemical tests, and questionnaires, including:
- Demographic information (age, sex, urban/rural classification, etc.);
- Height, weight, waist circumference, blood pressure;
Key exclusion criteria (1 listed)
- Exclusion criteria include missing core baseline or follow-up data relevant to each part. The medical conditions under investigation include overweight and obesity, along with their comorbidity with CVD and associated risk factors.
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 | Part 1, Part 2, Part 3 |
Primary outcome
Primary End point
Time frame: 2013-2023
Primary outcome: prevalence of cardiovascular disease (CVD), defined as the proportion of participants reporting a physician diagnosis or self-reported history of coronary heart disease, stroke, heart failure, or peripheral artery disease. We will summarize how common CVD and related conditions are in the study population. Categorical variables (e.g., overweight/obesity, central obesity, prior diagnoses) will be reported as counts and percentages. Continuous variables (e.g., BMI, waist circumference) will be reported as n, mean, and SD. For each survey year (2013, 2018, 2023) we will compute crude and age-standardized, population-weighted prevalence estimates. Trends over time will be assessed using Joinpoint regression to estimate the Average Annual Percent Change (AAPC) with 95% confidence intervals.
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 22 Jan 2026.
- 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
2 sites 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 2 sites in China.
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 9 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 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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?
Primary End point (time frame: 2013-2023). 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 22 Jan 2026.