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

A Phase 3 Clinical Study to Evaluate the Efficacy and Safety of HRS-7535 Tablets in Subjects With Overweight or Obesity

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

Study Overview

• Status: Active, not recruiting
• Conditions: Obesity; Overweight
• Intervention / Treatment: Drug: HRS-7535 Tablets; Drug: HRS-7535 Placebo Tablets

• Study Type: Interventional
• Enrollment (Actual): 556
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100039
      • Chinese PLA General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HRS-7535 Group	Drug: HRS-7535 Tablets; HRS-7535 tablets.
Placebo Comparator: HRS-7535 Placebo Group	Drug: HRS-7535 Placebo Tablets; HRS-7535 placebo tablets.

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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.

Collaborators and Investigators

• Sponsor: Shandong Suncadia Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2025
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: March 25, 2025
• First Submitted That Met QC Criteria: March 25, 2025
• First Posted (Actual): April 1, 2025

Study Record Updates

• Last Update Posted (Actual): June 22, 2025
• Last Update Submitted That Met QC Criteria: June 19, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity
• Other Study ID Numbers: HRS-7535-303

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No