HRS9531 tablets for adults with type 2 diabetes not controlled by lifestyle or metformin

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2 interventional study comparing HRS9531 tablets to placebo over about 20 weeks in adults with type 2 diabetes. Eligible participants have had diabetes for at least 6 months, an HbA1c between 7.5% and 10.5%, and stable lifestyle or metformin therapy for at least 8 weeks. The study will evaluate the safety and efficacy of daily HRS9531 tablet dosing in addition to current background care. The trial is conducted at two sites in China and uses a parallel-group design with randomization to HRS9531 or placebo. Primary outcomes focus on glycemic control and safety signals relevant to this population.

Why it matters

Who can join: the full rules

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.

Where it's running

• Beijing Chaoyang Hospital, Capital Medical University
  Beijing, Beijing Municipality, China Recruiting
• Qilu Hospital of Shandong University
  Jinan, Shandong, China Recruiting

Study contacts

• Study coordinator: Junmeng Shi
• Email: junmeng.shi.js12@hengrui.com
• Phone: 17721288226

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.