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Not yet recruitingPhase 2

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.

Asset

HRS9531

Oral · GLP-1 / GIP dual

Listed sites

2

Recruiting sites

Enrollment

240

estimated

Study population

Type 2 diabetes

Key I/E criterion

HbA1c 7.5-10.5%

Primary endpoint

HbA1c, % change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07599410
Org study IDHRS9531-T-202

Timeline

Milestones

Study first posted2026-05-20actual
Last update posted2026-05-20actual
Study start2026-07estimated (month precision)
Primary completion2027-05estimated (month precision)
Study completion2027-07estimated (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age70 Years
SexAll
Healthy volunteersNot accepted

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.

Endpoints (6)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes
3
Safety / tolerability / PK
2
Weight & body composition
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Percentage change in fasting body weight relative to baseline

Time frame:Week 20

Body weight, % change

percent change from baseline, improvement

Glycemic / diabetes

3 endpoints
Primary/protocol endpoint

Change in glycated hemoglobin (HbA1c) relative to baseline

Time frame:Week 20.

HbA1c, % change

percent change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of participants achieving HbA1c < 7.0%

Time frame:Week 20

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in fasting plasma glucose (FPG) relative to baseline

Time frame:Week 20

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Safety / tolerability / PK

2 endpoints
Secondary/protocol endpoint

Incidence of hypoglycemic events across all groups

Time frame:Week 20

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Incidence of adverse events (AEs) across all groups

Time frame:Week 20

Treatment-emergent AEs (any)

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.