Status:
ACTIVE_NOT_RECRUITING
A Trial of HRS-7535 Tablets in Subjects With Overweight or Obesity
Lead Sponsor:
Shandong Suncadia Medicine Co., Ltd.
Conditions:
Overweight
Obesity
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The study is being conducted to evaluate the efficacy and safety of HRS-7535 in subjects with overweight or obesity.
Eligibility Criteria
Inclusion
- On the day of signing the informed consent form, the age should be between 18 and 75 years old.
- At the screening period, the Body Mass Index (BMI) should meet the criteria of ≥ 28.0 kg/m², or ≥ 24.0 kg/m² with at least one weight-related comorbidity, such as hyperglycemia, hypertension, dyslipidemia, obstructive sleep apnea, or non-alcoholic fatty liver disease.
- The participant should have controlled their diet and exercise for 3 months or more prior to screening and randomization, and the weight change in the past 3 months should not exceed 5%.
- Before the trial, the participants must voluntarily sign the informed consent form, fully understand the trial content, procedures and potential adverse reactions, and have the ability and willingness to comply with the protocol requirements to complete this study.
Exclusion
- At the screening period, relevant laboratory test results are abnormal.
- Electrocardiogram (ECG) results at the screening period show clinically significant abnormalities.
- Uncontrolled severe hypertension at the screening period.
- Presence of endocrine diseases that may significantly affect the body weight.
- History of acute or chronic pancreatitis.
- History of significant gastrointestinal diseases.
- Severe infections, significant trauma, or major surgery within 30 days prior to screening, as judged by the investigator.
- Use of medications or treatments that may cause significant weight gain or loss within 90 days prior to screening.
- Known or suspected abuse of alcohol or narcotics.
- Any condition deemed by the investigator to be unsuitable for participation in this clinical trial.
Key Trial Info
Start Date :
April 9 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2026
Estimated Enrollment :
556 Patients enrolled
Trial Details
Trial ID
NCT06904105
Start Date
April 9 2025
End Date
May 1 2026
Last Update
June 22 2025
Active Locations (1)
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1
Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100039