Chinese, Overweight or Obesity, Real-World Registry Study

NCT07525037 | Not Yet Recruiting

• 1 other identifier: S2025-730-02
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief 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 \[3 items\], 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.

Conditions

Obesity Type 2 Diabetes Mellitus

Keywords

Real world study; Obesity Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

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

  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)

  6 months and 12 months

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

  6 months and 12 months

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

  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.

  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.

  6 months and 12 months

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.

  1 year

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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 -

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese PLA General Hospital

Haidian, Being, 100039, China

Location

Central Study Contacts

MuYiming

CONTACT

86+13910580089; muyiming@301hospital.com.cn

ChenKang

CONTACT

010-55499401; cycon_ck@yeah.net

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of the Endocrinology Department

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: April 13, 2026
• Study Start: May 30, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-03

Locations

CN (1)