A Research Study to Investigate the Efficacy and Safety of HRS9531 Tablets in Participants With Type 2 Diabetes Mellitus

July 21, 2026 updated by: Fujian Shengdi Pharmaceutical Co., Ltd.

A Multicenter, Randomized, Double Blind, Placebo Controlled, Parallel Group Phase 2 Study to Evaluate the Efficacy and Safety of HRS9531 Tablets in Participants With Type 2 Diabetes Mellitus.

The aim of the trial is to investigate the efficacy and safety of HRS9531 tablets versus placebo in participants with type 2 diabetes mellitus who failed to achieve adequate glycemic control on lifestyle intervention alone or on a stable dose of metformin. This study will last 20 weeks.

Study Overview

Status

Status

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

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 (Estimated)

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.
240

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 Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100020
        • Recruiting
        • Beijing Chaoyang Hospital, Capital Medical University
        • Principal Investigator:
          • Guang Wang
    • Shandong
      • Jinan, Shandong, China, 250012
        • Recruiting
        • Qilu Hospital of Shandong University
        • Principal Investigator:
          • Xinguo Hou

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. Male or female, aged 18 to 70 years on the day of signing the informed consent form;
  2. Have a documented history of type 2 diabetes mellitus for at least 6 months at screening, diagnosed according to the criteria in Guidelines for the Prevention and Treatment of Type 2 Diabetes in China (2024 Edition);
  3. HbA1c between 7.5% and 10.5% at screening;
  4. Have received lifestyle intervention alone for at least 8 weeks, or stable metformin monotherapy for at least 8 weeks prior to screening. Stable treatment is defined as no change in daily drug dosage, with no planned modifications to the regimen during the entire trial period;
  5. Fasting plasma glucose ≤ 15 mmol/L;
  6. Body mass index (BMI) between 20.0 kg/m² and 40.0 kg/m² at screening;
  7. Voluntarily sign the informed consent form before the trial, fully understand the trial content, procedures and potential adverse reactions, and be able and willing to comply with protocol requirements to complete the study;
  8. Have no fertility plans from the signing of the informed consent form until 2 months after the last dose, and agree to use highly effective contraceptive measures as specified in the protocol.methods.

Exclusion Criteria:

  1. Participants with relevant abnormal test results at screening.
  2. Participants with clinically significant abnormal findings on electrocardiogram (ECG) that, in the investigator's opinion, may compromise subject safety.
  3. Participants with poorly controlled blood pressure.
  4. Participants diagnosed with or suspected of having type 1 diabetes, specific types of diabetes, or secondary diabetes.
  5. Participants who experienced acute diabetic complications within 6 months prior to screening.
  6. Participants who experienced severe hypoglycemic events or recurrent hypoglycemic events within 6 months prior to screening.
  7. Participants with severe chronic diabetic complications at screening, or non-proliferative diabetic retinopathy requiring treatment during the trial.
  8. Participants with a past or known history or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2).
  9. Participants with a past or known history of acute or chronic pancreatitis, pancreatic injury, acute cholecystitis, or symptomatic/treatment requiring gallbladder disease.
  10. Participants with a past history of significant gastrointestinal diseases (such as severe diabetic gastroparesis, gastric outlet obstruction, inflammatory bowel disease, active ulcer, etc.), or who have undergone gastrointestinal surgery (excluding gastrointestinal polypectomy and appendectomy), or who are taking long-term medications that directly affect gastrointestinal motility.
  11. Participants with a history of severe cardiovascular or cerebrovascular diseases within 6 months prior to screening.
  12. Participants with known or suspected depression, bipolar disorder, suicidal ideation, schizophrenia, or other severe psychiatric disorders; or participants who are mentally incompetent, have language barriers, are unable to fully understand the trial protocol, or are unwilling to cooperate with study site staff.
  13. Participants with a history of malignant tumor within 5 years prior to screening, except for cured localized cancers such as localized basal cell carcinoma of the skin, cervical carcinoma in situ, and prostate carcinoma in situ.
  14. Female participants who are pregnant, breastfeeding, or planning to become pregnant during the trial.
  15. Any other conditions that, in the investigator's judgment, render the subject unsuitable for participation in this clinical trial.

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 Tablet
Drug: HRS9531 Tablet
HRS9531 Tablet dose 1
Drug: HRS9531 Tablet
HRS9531 Tablet dose 2
Drug: HRS9531 Tablet
HRS9531 Tablet dose 3
Drug: HRS9531 Tablet
HRS9531 Tablet dose 4
Drug: HRS9531 Tablet
HRS9531 Tablet dose 5
Experimental: Treatment group B: HRS9531 Tablet
Drug: HRS9531 Tablet
HRS9531 Tablet dose 1
Drug: HRS9531 Tablet
HRS9531 Tablet dose 2
Drug: HRS9531 Tablet
HRS9531 Tablet dose 3
Drug: HRS9531 Tablet
HRS9531 Tablet dose 4
Drug: HRS9531 Tablet
HRS9531 Tablet dose 5
Experimental: Treatment group C: HRS9531 Tablet
Drug: HRS9531 Tablet
HRS9531 Tablet dose 1
Drug: HRS9531 Tablet
HRS9531 Tablet dose 2
Drug: HRS9531 Tablet
HRS9531 Tablet dose 3
Drug: HRS9531 Tablet
HRS9531 Tablet dose 4
Drug: HRS9531 Tablet
HRS9531 Tablet dose 5
Experimental: Treatment group D: HRS9531 Tablet
Drug: HRS9531 Tablet
HRS9531 Tablet dose 1
Drug: HRS9531 Tablet
HRS9531 Tablet dose 2
Drug: HRS9531 Tablet
HRS9531 Tablet dose 3
Drug: HRS9531 Tablet
HRS9531 Tablet dose 4
Drug: HRS9531 Tablet
HRS9531 Tablet dose 5
Experimental: Treatment group E: HRS9531 Tablet
Drug: HRS9531 Tablet
HRS9531 Tablet dose 1
Drug: HRS9531 Tablet
HRS9531 Tablet dose 2
Drug: HRS9531 Tablet
HRS9531 Tablet dose 3
Drug: HRS9531 Tablet
HRS9531 Tablet dose 4
Drug: HRS9531 Tablet
HRS9531 Tablet dose 5
Placebo Comparator: Treatment group F:Placebo
Drug: HRS9531 Tablet placebo
HRS9531 Tablet placebo

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
Change in glycated hemoglobin (HbA1c) relative to baseline
Time Frame: Week 20.
Week 20.

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
Percentage of participants achieving HbA1c < 7.0%
Time Frame: Week 20
Week 20
Percentage change in fasting body weight relative to baseline
Time Frame: Week 20
Week 20
Change in fasting plasma glucose (FPG) relative to baseline
Time Frame: Week 20
Week 20
Incidence of hypoglycemic events across all groups
Time Frame: Week 20
Week 20
Incidence of adverse events (AEs) across all groups
Time Frame: Week 20
Week 20

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.
July 14, 2026

Primary Completion (Estimated)

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.
May 1, 2027

Study Completion (Estimated)

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 1, 2027

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 11, 2026

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 14, 2026

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 20, 2026

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 23, 2026

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 21, 2026

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, 2026

More Information

Terms related to this study

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-T-202

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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