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

Phase 3

Recruiting

• Conditions: Overweight; Obesity
• Interventions: Drug: HRS-7535 Tablets; Drug: HRS-7535 Placebo Tablets

• Registration Number: NCT06904105
• Lead Sponsor: Shandong Suncadia Medicine Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-25
• Study First Submitted QC: 2025-03-25
• Status Verified: 2025-04
• Study First Posted: 2025-04-01
• Study Start: 2025-04-09
• Last Update Submitted: 2025-04-20
• Last Update Posted: 2025-04-22
• Primary Completion: 2026-04
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 550

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HRS-7535 Group	HRS-7535 Tablets	-
HRS-7535 Placebo Group	HRS-7535 Placebo Tablets	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China