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

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: Not yet recruiting
• Conditions: T2DM
• Intervention / Treatment: Drug: HRS9531 Tablet; Drug: HRS9531 Tablet; Drug: HRS9531 Tablet; Drug: HRS9531 Tablet placebo; Drug: HRS9531 Tablet; Drug: HRS9531 Tablet

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Junmeng Shi; Phone Number: 17721288226; Email: junmeng.shi.js12@hengrui.com

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: May 11, 2026
• First Submitted That Met QC Criteria: May 14, 2026
• First Posted (Actual): May 20, 2026

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID 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