Obesity Type 2 Diabetes MellitusNCT07525037
Chinese, Overweight or Obesity, Real-World Registry Study
An observational study of Obesity Type 2 Diabetes Mellitus, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
This study will enroll 10,000 patients with obesity, with the participation of approximately 50 medical institutions nationwide. At baseline, demographic data, physical examinations, multiple laboratory tests (including complete blood count, urinalysis, liver/renal function, electrolytes, thyroid function panel [3… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Obesity Type 2 Diabetes Mellitus
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 30 May 2026to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 1. Male or female patients over 18 years old 2. Diagnosed as overweight or obese, with a BMI of ≥ 24 kg/m² 3. Willing and able to use weight management apps 4. Willing and able to provide a written informed consent for participating in the study 5. Patients who meet the instructions for weight loss medication and have no contraindications to medication
Who may be able to join
- According to local regulations, the subjects included in the study should meet the following criteria:
- Male or female patients aged 18 years or above
- Diagnosed with overweight or obesity, with a BMI of ≥ 24 kg/m²
- Willing and able to use weight management apps
- Willing and able to provide a written informed consent for participating in the study
- Patients who meet the instructions for weight loss medication and have no contraindications to non-pharmacological treatments -
Who cannot join
- Having life-threatening comorbidities, with an expected lifespan of less than one year.
- Participating in an interventional trial that requires informed consent.
- Engaging in other organized weight loss programs or other clinical trials.
- Researchers identify any situation that may endanger the safety or compliance of the subjects.
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Chinese PLA General Hospital
Haidian, Being, 100039
ChenKang, 010-55499401, cycon_ck@yeah.net
About this study
Official title: Chinese Registry of Overweight or Obesity, a Multicenter Real-World Registry Study on Clinical Management - CROWN Study
This study will enroll 10,000 patients with obesity, with the participation of approximately 50 medical institutions nationwide. At baseline, demographic data, physical examinations, multiple laboratory tests (including complete blood count, urinalysis, liver/renal function, electrolytes, thyroid function panel [3 items], urine albumin/creatinine ratio, fasting glucose, fasting C-peptide, fasting insulin, HbA1c, blood lipids, etc.) and hepatic elasticity ultrasound will be performed. Patients will receive weight-loss therapy in routine clinical practice. Data on clinic visits, adverse events, and changes in therapeutic regimens will be centrally collected by investigators or their authorized representatives at Week 26 and Week 52.
Read the detailed description
This is a prospective, multicenter registry study designed to investigate the clinical characteristics and prognosis of obese patients in China, which may provide insights and opportunities to narrow the gaps in obesity-related clinical practice and improve clinical practice standards in China. The study will recruit 10,000 subjects from weight management clinics or endocrinology departments of 50 tertiary or higher-level medical institutions nationwide and follow them up for one year.
Researchers will obtain informed consent for study participation from obese patients during routine clinical visits, after which patients will be enrolled and registered.
Subsequently, subjects will undergo a baseline visit and be invited to participate in this 1 year observational registry study. They will receive clinical evaluations and the treatment regimens prescribed by their treating physicians.
Following the scheduled baseline visit, subjects will continue to be followed up for 1 year through routine clinical care as part of this observational study, and all collected data will be uploaded to the registry center.
- Conditions
- Obesity Type 2 Diabetes Mellitus
- Keywords
- Real world study, Obesity Type 2 Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
The treatment model for overweight and obese individuals in China at present.
Measured: 1 year
Secondary outcomes (7)
Observe the changes in liver fat content and liver stiffness in Chinese overweight and obese patients after 6 months and 12 months of follow-up: Liver stiffness measurement (LSM) and control attenuation index (Cap)
Measured: 6 months and 12 months
Observe the changes in body weight after 6 months and 12 months of follow-up: BMI
Measured: 6 months and 12 months
Evaluation of risk factors related to fatty liver disease in obesity combined with metabolic dysfunction
Measured: 6 months and 12 months
Observe the changes in related metabolic indicators over 6 months and 12 months, including changes in indicators such as blood lipids, blood pressure, and blood sugar.
Measured: 6 months and 12 months
Conduct a subset analysis for patients undergoing weight loss treatment with Mazdutide, analyzing related indicators including weight, metabolic indicators, cardiovascular and renal outcomes, and adverse reactions.
Measured: 6 months and 12 months
Observe the social demographic and clinical characteristics of obese and overweight patients
- Describe different social demographic characteristics (age, gender, race, education level, marital status, family history, physical activity, smoking history, alcohol consumption.
- Describe different clinical characteristics (body mass index [BMI], body fat percentage, waist circumference, waist-to-hip ratio, waist-to-height ratio, duration of obesity, duration of fatty liver disease, the number, type, and prevalence of other obesity-related comorbidities: especially non-alcoholic fatty liver disease, polycystic ovary syndrome, sleep apnea syndrome, etc.)
- Compare the differences in demographic and clinical characteristics among different groups of patients with different regions, different degrees of obesity, etc.
Measured: 6 months and 12 months
Observe the impact of different weight management methods on cardiovascular and renal outcomes and their risk factors.
- Observe the changes in weight-related indicators and metabolic-related
- Compare the differences in cardiovascular and renal outcomes among different populations.
Measured: 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start30 May 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yiming Mu, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07525037
- Sponsor's protocol ID
- S2025-730-02
- Status last verified
- Mar 2026
- First submitted
- 18 Mar 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chinese Registry of Overweight or Obesity, a Multicenter Real-World Registry Study on Clinical Management - CROWN Study
- ClinicalTrials.gov ID
- NCT07525037
- Acronym / sponsor ID
- S2025-730-02
- Conditions
- Obesity Type 2 Diabetes Mellitus
- Keywords
- Real world study, Obesity Type 2 Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 30 May 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 13 Apr 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 will enroll 10,000 patients with obesity, with the participation of approximately 50 medical institutions nationwide. At baseline, demographic data, physical examinations, multiple laboratory tests (including complete blood count, urinalysis, liver/renal function, electrolytes, thyroid function panel [3 items], urine albumin/creatinine ratio, fasting glucose, fasting C-peptide, fasting insulin, HbA1c, blood lipids, etc.) and hepatic elasticity ultrasound will be performed. Patients will receive weight-loss therapy in routine clinical practice. Data on clinic visits, adverse events, and changes in therapeutic regimens will be centrally collected by investigators or their authorized representatives at Week 26 and Week 52.
Detailed description
This is a prospective, multicenter registry study designed to investigate the clinical characteristics and prognosis of obese patients in China, which may provide insights and opportunities to narrow the gaps in obesity-related clinical practice and improve clinical practice standards in China. The study will recruit 10,000 subjects from weight management clinics or endocrinology departments of 50 tertiary or higher-level medical institutions nationwide and follow them up for one year.
Researchers will obtain informed consent for study participation from obese patients during routine clinical visits, after which patients will be enrolled and registered.
Subsequently, subjects will undergo a baseline visit and be invited to participate in this 1 year observational registry study. They will receive clinical evaluations and the treatment regimens prescribed by their treating physicians.
Following the scheduled baseline visit, subjects will continue to be followed up for 1 year through routine clinical care as part of this observational study, and all collected data will be uploaded to the registry center.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 1. Male or female patients over 18 years old 2. Diagnosed as overweight or obese, with a BMI of ≥ 24 kg/m² 3. Willing and able to use weight management apps 4. Willing and able to provide a written informed consent for participating in the study 5. Patients who meet the instructions for weight loss medication and have no contraindications to medication
Key inclusion criteria (6 listed)
- According to local regulations, the subjects included in the study should meet the following criteria:
- Male or female patients aged 18 years or above
- Diagnosed with overweight or obesity, with a BMI of ≥ 24 kg/m²
- Willing and able to use weight management apps
- Willing and able to provide a written informed consent for participating in the study
Key exclusion criteria (5 listed)
- Having life-threatening comorbidities, with an expected lifespan of less than one year.
- Participating in an interventional trial that requires informed consent.
- Engaging in other organized weight loss programs or other clinical trials.
- Researchers identify any situation that may endanger the safety or compliance of the subjects.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The treatment model for overweight and obese individuals in China at present.
Time frame: 1 year
7 secondary outcomes
Observe the changes in liver fat content and liver stiffness in Chinese overweight and obese patients after 6 months and 12 months of follow-up: Liver stiffness measurement (LSM) and control attenuation index (Cap)
Time frame: 6 months and 12 months
Observe the changes in body weight after 6 months and 12 months of follow-up: BMI
Time frame: 6 months and 12 months
Evaluation of risk factors related to fatty liver disease in obesity combined with metabolic dysfunction
Time frame: 6 months and 12 months
Observe the changes in related metabolic indicators over 6 months and 12 months, including changes in indicators such as blood lipids, blood pressure, and blood sugar.
Time frame: 6 months and 12 months
Conduct a subset analysis for patients undergoing weight loss treatment with Mazdutide, analyzing related indicators including weight, metabolic indicators, cardiovascular and renal outcomes, and adverse reactions.
Time frame: 6 months and 12 months
Observe the social demographic and clinical characteristics of obese and overweight patients
Time frame: 6 months and 12 months
Observe the impact of different weight management methods on cardiovascular and renal outcomes and their risk factors.
Time frame: 6 months and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
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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.
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 Type 2 Diabetes Mellitus, run by Chinese PLA General Hospital at 1 site 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 6 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: opening soon, as of the sponsor's last update on 13 Apr 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact MuYiming (86+13910580089, muyiming@301hospital.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The treatment model for overweight and obese individuals in China at present. (time frame: 1 year). 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 13 Apr 2026.