Overweight, Obesity
Conditions
Brief summary
The study is being conducted to evaluate the efficacy and safety of HRS-7535 in subjects with overweight or obesity.
Interventions
DRUGHRS-7535 Tablets
HRS-7535 tablets.
DRUGHRS-7535 Placebo Tablets
HRS-7535 placebo tablets.
Sponsors
Shandong Suncadia Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. On the day of signing the informed consent form, the age should be between 18 and 75 years old. 2. 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. 3. 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%. 4. 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 criteria
1. At the screening period, relevant laboratory test results are abnormal. 2. Electrocardiogram (ECG) results at the screening period show clinically significant abnormalities. 3. Uncontrolled severe hypertension at the screening period. 4. Presence of endocrine diseases that may significantly affect the body weight. 5. History of acute or chronic pancreatitis. 6. History of significant gastrointestinal diseases. 7. Severe infections, significant trauma, or major surgery within 30 days prior to screening, as judged by the investigator. 8. Use of medications or treatments that may cause significant weight gain or loss within 90 days prior to screening. 9. Known or suspected abuse of alcohol or narcotics. 10. Any condition deemed by the investigator to be unsuitable for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage change in body weight relative to the baseline. | The 50th week after administration. |
| The proportion of participants with a body weight reduction of ≥ 5% relative to the baseline. | The 50th week after administration. |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of participants with a body weight reduction of ≥ 10% relative to the baseline. | The 50th week after administration. |
| Adverse events (AEs). | About 52 weeks. |
Countries
China
Outcome results
None listed