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NCT Number: NCT07525037

Chinese, Overweight or Obesity, Real-World Registry 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.

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Key information

Conditions

Obesity Type 2 Diabetes Mellitus

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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 -

Exclusion criteria

  • 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.

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Treatment and study plan

Primary outcomes

  1. The treatment model for overweight and obese individuals in China at present.

    Time frame: 1 year

Secondary outcomes

  1. 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

  2. Observe the changes in body weight after 6 months and 12 months of follow-up: BMI

    Time frame: 6 months and 12 months

  3. Evaluation of risk factors related to fatty liver disease in obesity combined with metabolic dysfunction

    Time frame: 6 months and 12 months

  4. 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

  5. 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

  6. Observe the social demographic and clinical characteristics of obese and overweight patients

    Time frame: 6 months and 12 months

    • 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.

  7. Observe the impact of different weight management methods on cardiovascular and renal outcomes and their risk factors.

    Time frame: 6 months and 12 months

    • Observe the changes in weight-related indicators and metabolic-related
    • Compare the differences in cardiovascular and renal outcomes among different populations.

Other outcomes

  1. Analyze the impact of the frequency of patient usage and the use of different items (such as weight recording, body fat recording, recipe registration, exercise registration, etc.) on the outcome of the patient's weight management.

    Time frame: 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

ChenKang

CONTACT

[email protected]

010-55499401

MuYiming

CONTACT

[email protected]

86+13910580089

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Registry information

Official study title

Chinese Registry of Overweight or Obesity, a Multicenter Real-World Registry Study on Clinical Management - CROWN Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 13, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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