Efficacy and Safety of HRS9531 Injection in Obese Subjects Without Diabetes

April 29, 2025 updated by: Fujian Shengdi Pharmaceutical Co., Ltd.

A Multicenter, Randomized, Double-blind, Placebo- Parallel Controlled, Phase II Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Obese Subjects Without Diabetes

To evaluate the efficacy and dose-response relationship of HRS9531 injection compared with placebo in reducing body weight in obese subjects without diabetes after 24 weeks of treatment.

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.
249

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 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 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 Contact Backup

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230601
        • The Second Affiliated Hospital of Anhui Medical University
    • Beijing
      • Beijing, Beijing, China, 100191
        • Peking University Third Hospital
    • Chongqing
      • Chongqing, Chongqing, China, 400010
        • The Second Affiliated Hospital of Chongqing Medical University
    • Guangdong
      • Guangzhou, Guangdong, China, 510800
        • Huadu District People's Hospital of Guangzhou
      • Shenzhen, Guangdong, China, 518110
        • The people's hospital of Longhua.Shenzhen
    • Guangxi
      • Nanning, Guangxi, China, 530007
        • Department of Endocrinology，Sencond Affiliated Hospital of Guangxi Medical University
    • Hainan
      • Haikou, Hainan, China, 570102
        • The First Affiliated Hospital of Hainan Medical University
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150001
        • The Fourth Affiliated Hospital of Harbin Medical University
    • Henan
      • Luoyang, Henan, China, 471000
        • The First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and Technology
      • Nanyang, Henan, China, 473000
        • The First Affiliated Hospital of Nanyang Medical College
    • Hubei
      • Huangshi, Hubei, China, 435000
        • The Central Hospital Of Huangshi
      • Wuhan, Hubei, China, 430000
        • The Third People's Hospital of Hubei Province
    • Inner Mongolia
      • Baotou, Inner Mongolia, China, 014040
        • Baotou Central Hospital
    • Jiangsu
      • Lianyungang, Jiangsu, China, 222002
        • The first people's hospital of Lianyungang
      • Lianyungang, Jiangsu, China, 222001
        • Lianyungang Hospital of TCM
      • Xuzhou, Jiangsu, China, 221004
        • The Affiliated Hospital of Xuzhou Medical University
      • Yangzhou, Jiangsu, China, 225001
        • North Jiangsu People's Hospital
    • Jilin
      • Changchun, Jilin, China, 130022
        • The Second Hospital of Jilin University
    • Liaoning
      • Shenyang, Liaoning, China, 110004
        • Shengjing Hospital of China Medical University
    • Shanghai
      • Shanghai, Shanghai, China, 200030
        • Zhongshan hospital, Fudan university
      • Shanghai, Shanghai, China, 20032
        • Zhongshan Hospital Affiliated to Fudan University
    • Shanxi
      • Taiyuan, Shanxi, China, 030000
        • Second hospttoal of Shanxi medical University
    • Sichuan
      • Chengdu, Sichuan, China, 610000
        • Chengdu second people's hospital
    • Xian
      • Xian, Xian, China, 710000
        • The First Affiliated Hospital of Xi'an Medical College
    • Yunnan
      • Kunming, Yunnan, China, 650032
        • First Affiliated Hospital of Kunming Medical University
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310006
        • The First People's Hospital of Hangzhou

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, 18-65 years of age at the time of signing informed consent;
  3. At screening visit, 28.0 ≤BMI≤ 40.0 kg/m2;
  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.

Exclusion Criteria:

  1. Presence of - clinically significant lab or ECG results that may affect the evaluation of the efficacy or safety of the study drug 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 and in-situ cancer of the cervix;
  9. Confirmed or suspected depression, bipolar disorder, suicidal tendencies, schizophrenia, or other serious mental illness;
  10. History of alcohol and/or substance abuse or drug abuse within 1 year prior to screening;
  11. Use of any medication or treatment that may have caused significant weight change within 3 months;
  12. History of bariatric surgery;
  13. Known or suspected hypersensitivity to trial product(s) or related products;
  14. Participation in other clinical trials for any weight-loss indication within 3 months prior to screening, or participation in other clinical trials for any drug or medical device within 1 month prior to screening;
  15. history of blood donation or blood loss in the 3 months before screening, or blood transfusion in the 2 months before screening;
  16. Surgery is planned during the trial;
  17. Mentally incapacitated or speech-impaired;
  18. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method;
  19. Researchers and relevant staff of the research Centre or other people directly involved in the implementation of the programme, and their immediate family members.

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: Triple

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.
Experimental: Treatment group A
HRS9531 injection
Drug: HRS9531 injection
HRS9531 injection: dose level 2
Drug: HRS9531 injection
HRS9531 injection: dose level 3
Drug: HRS9531 injection
HRS9531 injection: dose level 4
Drug: HRS9531 injection
HRS9531 injection: dose level 1 for 32 weeks、level 2 for 20 weeks
Experimental: Treatment group B
HRS9531 injection
Drug: HRS9531 injection
HRS9531 injection: dose level 2
Drug: HRS9531 injection
HRS9531 injection: dose level 3
Drug: HRS9531 injection
HRS9531 injection: dose level 4
Drug: HRS9531 injection
HRS9531 injection: dose level 1 for 32 weeks、level 2 for 20 weeks
Experimental: Treatment group C
HRS9531 injection
Drug: HRS9531 injection
HRS9531 injection: dose level 2
Drug: HRS9531 injection
HRS9531 injection: dose level 3
Drug: HRS9531 injection
HRS9531 injection: dose level 4
Drug: HRS9531 injection
HRS9531 injection: dose level 1 for 32 weeks、level 2 for 20 weeks
Experimental: Treatment group D
HRS9531 injection
Drug: HRS9531 injection
HRS9531 injection: dose level 2
Drug: HRS9531 injection
HRS9531 injection: dose level 3
Drug: HRS9531 injection
HRS9531 injection: dose level 4
Drug: HRS9531 injection
HRS9531 injection: dose level 1 for 32 weeks、level 2 for 20 weeks
Placebo Comparator: Treatment group E
HRS9531 injection Placebo
Drug: HRS9531 injection Placebo
Placebo arm matching active arm HRS9531 injection dose level 1 for 32 weeks、HRS9531 injection level 2 for 20 weeks
Drug: HRS9531 injection Placebo
Placebo arm matching active arm HRS9531 injection dose level 2 for 32 weeks、HRS9531 injection level 2 for 20 weeks
Drug: HRS9531 injection Placebo
Placebo arm matching active arm HRS9531 injection dose level 3 for 32 weeks、HRS9531 injection level 2 for 20 weeks
Drug: HRS9531 injection Placebo
Placebo arm matching active arm HRS9531 injection dose level 4 for 32 weeks、HRS9531 injection level 2 for 20 weeks
Placebo Comparator: Treatment group F
HRS9531 injection Placebo
Drug: HRS9531 injection Placebo
Placebo arm matching active arm HRS9531 injection dose level 1 for 32 weeks、HRS9531 injection level 2 for 20 weeks
Drug: HRS9531 injection Placebo
Placebo arm matching active arm HRS9531 injection dose level 2 for 32 weeks、HRS9531 injection level 2 for 20 weeks
Drug: HRS9531 injection Placebo
Placebo arm matching active arm HRS9531 injection dose level 3 for 32 weeks、HRS9531 injection level 2 for 20 weeks
Drug: HRS9531 injection Placebo
Placebo arm matching active arm HRS9531 injection dose level 4 for 32 weeks、HRS9531 injection level 2 for 20 weeks
Placebo Comparator: Treatment group G
HRS9531 injection Placebo
Drug: HRS9531 injection Placebo
Placebo arm matching active arm HRS9531 injection dose level 1 for 32 weeks、HRS9531 injection level 2 for 20 weeks
Drug: HRS9531 injection Placebo
Placebo arm matching active arm HRS9531 injection dose level 2 for 32 weeks、HRS9531 injection level 2 for 20 weeks
Drug: HRS9531 injection Placebo
Placebo arm matching active arm HRS9531 injection dose level 3 for 32 weeks、HRS9531 injection level 2 for 20 weeks
Drug: HRS9531 injection Placebo
Placebo arm matching active arm HRS9531 injection dose level 4 for 32 weeks、HRS9531 injection level 2 for 20 weeks
Placebo Comparator: Treatment group H
HRS9531 injection Placebo
Drug: HRS9531 injection Placebo
Placebo arm matching active arm HRS9531 injection dose level 1 for 32 weeks、HRS9531 injection level 2 for 20 weeks
Drug: HRS9531 injection Placebo
Placebo arm matching active arm HRS9531 injection dose level 2 for 32 weeks、HRS9531 injection level 2 for 20 weeks
Drug: HRS9531 injection Placebo
Placebo arm matching active arm HRS9531 injection dose level 3 for 32 weeks、HRS9531 injection level 2 for 20 weeks
Drug: HRS9531 injection Placebo
Placebo arm matching active arm HRS9531 injection dose level 4 for 32 weeks、HRS9531 injection level 2 for 20 weeks

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
Measure Description
Time Frame
Percentage change in body weight
Time Frame: Week 0, Week 24
Percentage Change from baseline in body weight after 24 weeks of treatment
Week 0, Week 24

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 ≥5% from baseline in body weight after 24 weeks of treatment
Time Frame: Week 24
Week 24
Proportion of subjects with weight loss of ≥10% from baseline in body weight after 24 weeks of treatment
Time Frame: Week 24
Week 24
Change from baseline in body weight after 24 weeks of treatment
Time Frame: Week 0, Week 24
Week 0, Week 24
Change from baseline in waist circumference after 24 weeks of treatment
Time Frame: Week 0, Week 24
Week 0, Week 24
Change from baseline in BMI after 24 weeks of treatment
Time Frame: Week 0, Week 24
Week 0, Week 24
Change from baseline in blood pressure after 24 weeks of treatment
Time Frame: Week 0, Week 24
Week 0, Week 24
Change from baseline in total cholesterol after 24 weeks of treatment
Time Frame: Week 0, Week 24
Week 0, Week 24
Change from baseline in fasting plasma glucose (FPG) after 24 weeks of treatment
Time Frame: Week 0, Week 24
Week 0, Week 24
Change from baseline in glycosylated haemoglobin (HbA1c) after 24 weeks of treatment
Time Frame: Week 0, Week 24
Week 0, Week 24
Number of AEs During the Trial
Time Frame: Week 0 to Week 56
Week 0 to Week 56
Percentage change in body weight
Time Frame: Week 0, Week 32
Week 0, Week 32
Proportion of Subjects with weight loss of ≥5% from baseline in body weight after 32 weeks of treatment
Time Frame: Week 32
Week 32
Proportion of Subjects with weight loss of ≥10% from baseline in body weight after 32 weeks of treatment
Time Frame: Week 32
Week 32
Change from baseline in body weight after 32 weeks of treatment
Time Frame: Week 0, Week 32
Week 0, Week 32
Change from baseline in waist circumference after 32 weeks of treatment
Time Frame: Week 0, Week 32
Week 0, Week 32
Change from baseline in BMI after 32 weeks of treatment
Time Frame: Week 0, Week 32
Week 0, Week 32
Change from baseline in blood pressure after 32 weeks of treatment
Time Frame: Week 0, Week 32
Week 0, Week 32
Change from baseline in total cholesterol after 32 weeks of treatment
Time Frame: Week 0, Week 32
Week 0, Week 32
Change from baseline in fasting plasma glucose (FPG) after 32 weeks of treatment
Time Frame: Week 0, Week 32
Week 0, Week 32
Change from baseline in glycosylated haemoglobin (HbA1c) after 32 weeks of treatment
Time Frame: Week 0, Week 32
Week 0, Week 32

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.
June 13, 2023

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.
October 13, 2024

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.
October 13, 2024

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).
May 17, 2023

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.
May 29, 2023

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 31, 2023

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.
April 30, 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.
April 29, 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.
April 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.
  • HRS9531-201

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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