A Trial of HRS-7535 Tablets in Subjects With Overweight or Obesity

NCT ID: NCT06904105

Last Updated: 2025-06-22

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 556 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-09
• Study Completion Date: 2026-05-31

Brief Summary

The study is being conducted to evaluate the efficacy and safety of HRS-7535 in subjects with overweight or obesity.

Conditions

Overweight; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

HRS-7535 Group

Group Type: EXPERIMENTAL

HRS-7535 Tablets

Intervention Type: DRUG

HRS-7535 tablets.

HRS-7535 Placebo Group

Group Type: PLACEBO_COMPARATOR

HRS-7535 Placebo Tablets

Intervention Type: DRUG

HRS-7535 placebo tablets.

Interventions

HRS-7535 Tablets

HRS-7535 tablets.

Intervention Type: DRUG

HRS-7535 Placebo Tablets

HRS-7535 placebo tablets.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shandong Suncadia Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

HRS-7535-303

Identifier Type: -

Identifier Source: org_study_id