Long-term Efficacy and Safety of HRS-7535 Tablets in Obese Subjects

November 13, 2025 updated by: Shandong Suncadia Medicine Co., Ltd.

HRS-7535-202 Follow-up Study: A Long-term Evaluation of Safety, Tolerability, and Efficacy in Obese Subjects (Open-label, Extension Trial)

The Objective of this trial is to evaluate the long-term safety, tolerability, weight loss efficacy and metabolic benefits of HRS-7535 tablets inobesity.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

81

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male or female subjects, 18-65 years of age at the time of signing informed consent;
  2. Subjects who have completed the entire 36-week treatment course of the HRS-7535-202 trial.
  3. Subjects who have a full understanding of the trial content, processes, and possible adverse reactions, and are capable and willing to comply with the protocol requirements to complete this study.

Exclusion Criteria:

  1. Participants with poor compliance during the 36-week open-label extension treatment of the HRS-7535-202 trial;
  2. Pregnant, lactating, planning to conceive during the trial period, or fertile subjects unwilling to take effective contraceptive measures during the trial period.
  3. Any other conditions deemed unsuitable for participation in this clinical trial by the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Subjects will receive escalated dose of HRS-7535 or maximum tolerated dose orally
Drug: HRS-7535
HRS-7535
Experimental: Group B
Subjects will receive escalated dose of HRS-7535 or maximum tolerated dose orally
Drug: HRS-7535
HRS-7535
Experimental: Group C
Subjects will receive escalated dose of HRS-7535 or maximum tolerated dose orally
Drug: HRS-7535
HRS-7535
Experimental: Group D
Subjects will receive escalated dose of HRS-7535 or maximum tolerated dose orally
Drug: HRS-7535
HRS-7535

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with Treatment-emergent Adverse Event(AE)
Time Frame: During the 32-week open-label extension treatment period
During the 32-week open-label extension treatment period

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage change in body weight from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;
Time Frame: from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;
from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;
Proportion of subjects with ≥5%, ≥10%, and ≥15% weight reduction from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;
Time Frame: from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;
from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;
Changes in weight from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;
Time Frame: from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;
from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;
Changes in waist circumference from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;
Time Frame: from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;
from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;
Changes in body mass index (BMI) from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;
Time Frame: from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;
from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong Suncadia Medicine Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2024

Primary Completion (Actual)

August 15, 2025

Study Completion (Actual)

September 28, 2025

Study Registration Dates

First Submitted

October 23, 2024

First Submitted That Met QC Criteria

November 1, 2024

First Posted (Actual)

November 4, 2024

Study Record Updates

Last Update Posted (Actual)

November 17, 2025

Last Update Submitted That Met QC Criteria

November 13, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • HRS-7535-202-Extension

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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