To Compare the Efficacy and Safety of HRS9531 and Placebo in Subjects With Overweight or Obese

July 10, 2025 updated by: Fujian Shengdi Pharmaceutical Co., Ltd.

Efficacy and Safety of HRS9531 in Overweight or Obese Participants: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial

The study aims to evaluate the efficacy and safety of HRS9531 in subjects with overweight or obese for 48 weeks.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
567

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Zhongshan Hospital Affiliated to Fudan University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Able and willing to provide a written informed consent.
  2. Male or female subjects, ≥18 years of age at the time of signing informed consent.
  3. At screening visit, BMI≥28.0 Kg/m2, or ≥24 Kg/m2 with at least one weight-related complication, such as prediabetes, hypertension, dyslipidemia, obstructive sleep apnea, and nonalcoholic fatty liver disease.
  4. Diet and exercise control for at least 3 months before screening visit, and less than 5 kg self-reported change within the last 3 months.
  5. Fertile male and female subjects (including partners) have no plans to have children and agree to use effective contraception within 2 months after signing the informed consent form and the last medication, and fertile female or male subjects have no plans to donate eggs/sperm; Fertile female subjects tested negative for regnancy within the first 3 days of randomization and were not lactating.

Exclusion Criteria:

  1. Presence of clinically significant lab results at screening visit;
  2. Uncontrollable hypertension;
  3. PHQ-9 score ≥15;
  4. Medical history or illness that affects your weight;
  5. History of diabetes;
  6. Acute infection, acute trauma, or medium to large surgery within 1 month prior to screening;
  7. History of acute cardiovascular and cerebrovascular diseases within 6 months prior to screening;
  8. Any organ-system malignancies developed within 5 years except for cured local basal cell cancer of the skin、 in-situ cancer of the cervix and in-situ cancer of the prostate;
  9. Confirmed or suspected depression, bipolar disorder, suicidal tendencies, schizophrenia, or other serious mental illness;
  10. Known or suspected history of alcohol and/or substance abuse or drug abuse;
  11. History of acute or chronic hepatitis or other serious liver disease other than alcoholic fatty liver disease.
  12. Have received or plan to have an organ or bone marrow transplant during the study.
  13. The presence of any blood disorders that may interfere with HbA1c testing.
  14. Autoimmune disease is present and systemic glucocorticoid therapy or immunosuppressive therapy is planned during the study.
  15. Use of drugs or treatments that may have caused significant weight gain or loss within the 3 months prior to screening;
  16. Weight loss surgery or endoscopic and/or medical device-based weight loss therapy is planned for or during the study period;
  17. Use of drugs or treatments that may have caused significant weight gain or loss within the 3 months prior to screening;
  18. Patients with blood donation or blood loss ≥400 mL or receiving blood transfusion within 3 months before screening.
  19. Surgery is planned during the tria;
  20. Mentally incapacitated or speech-impaired subjects are unable to fully understand or participate in the test process；
  21. In the investigator's judgment, there are circumstances (medical, psychological, social, or geographical factors, etc.) that affect subject safety or any other conditions that interfere with the evaluation of the test results.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo injection
Drug: Placebo
blank preparation, participants received matching placebo.
Experimental: Treatment group A: HRS9531 injection
Drug: HRS9531 injection
HRS9531 injection; low dose
Drug: HRS9531 injection
HRS9531 injection; medium dose
Drug: HRS9531 injection
HRS9531 injection, high dose
Experimental: Treatment group B: HRS9531 injection
Drug: HRS9531 injection
HRS9531 injection; low dose
Drug: HRS9531 injection
HRS9531 injection; medium dose
Drug: HRS9531 injection
HRS9531 injection, high dose
Experimental: Treatment group C: HRS9531 injection
Drug: HRS9531 injection
HRS9531 injection; low dose
Drug: HRS9531 injection
HRS9531 injection; medium dose
Drug: HRS9531 injection
HRS9531 injection, high dose

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Percentage change from baseline in weight after 48 weeks of treatment
Time Frame: Baseline, Week 48
Baseline, Week 48
Proportion of subjects with weight loss of≥5% from baseline after 48 weeks of treatment
Time Frame: Week 48
Week 48

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Proportion of subjects with weight loss of ≥10% from baseline after 48 weeks of treatment
Time Frame: Week 48
Week 48
Proportion of subjects with weight loss of ≥15% from baseline after 48 weeks of treatment
Time Frame: Week 48
Week 48
Change from baseline in waist circumference after 48 weeks of treatment
Time Frame: Baseline, Week 48
Baseline, Week 48
Change from baseline in weight after 48 weeks of treatment
Time Frame: Baseline, Week 48
Baseline, Week 48
Change from baseline in BMI after 48 weeks of treatment
Time Frame: Baseline, Week 48
Baseline, Week 48
Change from baseline in systolic blood pressure after 48 weeks of treatment
Time Frame: Baseline, Week 48
Baseline, Week 48
Change from baseline in diastolic blood pressure after 48 weeks of treatment
Time Frame: Baseline, Week 48
Baseline, Week 48
Change from baseline in Total Cholesterol after 48 weeks of treatment
Time Frame: Baseline, Week 48
Baseline, Week 48
Change from baseline in Low Density Lipoprotein (LDL) Cholesterol after 48 weeks of treatment
Time Frame: Baseline, Week 48
Baseline, Week 48
Change from baseline in Triglycerides after 48 weeks of treatment
Time Frame: Baseline, Week 48
Baseline, Week 48
Change from baseline in High Density Lipoprotein (HDL) Cholesterol after 48 weeks of treatment
Time Frame: Baseline, Week 48
Baseline, Week 48
Change from baseline in fasting plasma glucose (FPG) after 48 weeks of treatment
Time Frame: Baseline, Week 48
Baseline, Week 48
Change from baseline in glycosylated haemoglobin (HbA1c) after 48 weeks of treatment
Time Frame: Baseline, Week 48
Baseline, Week 48
Change from baseline in fasting serum insulin after 48 weeks of treatment
Time Frame: Baseline, Week 48
Baseline, Week 48
Change in scores of SF-36 V2 from baseline after 48 weeks of treatment
Time Frame: Baseline, Week 48
Baseline, Week 48
Number of AEs during the trial
Time Frame: week 0 to week 52
week 0 to week 52

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fujian Shengdi Pharmaceutical 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 13, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 7, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 7, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 30, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 2, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 11, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HRS9531-301

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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