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RecruitingPhase 3

Efficacy and Safety of HRS9531 in Participants With Type 2 Diabetes Treated With Basal Insulin

A Phase III, Multicenter, Randomized, Double Blinded, Parallel-controlled Study Comparing the Efficacy and Safety of HRS9531 Versus Placebo in Subjects With Type 2 Diabetes Mellitus Inadequately Controlled With Basal Insulin.

Asset

HRS9531

GLP-1 / GIP dual

Listed sites

1

Recruiting sites

1

Enrollment

300

estimated

Study population

Type 2 diabetes

Key I/E criterion

BMI ≥22

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 IDNCT07060456
Org study IDHRS9531-305

Timeline

Milestones

Study first posted2025-07-11actual
Study start2025-07-25actual
Last update posted2026-01-02actual
Primary completion2027-02estimated (month precision)
Study completion2027-03estimated (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Male or female, able and willing to provide a written informed consent

2. Diagnosed with type 2 diabetes ≥ 90 days;

3. On stable once-daily dose of basal insulin alone or in combination with metformin and/or SGLT2 inhibitor ≥ 90 days;

4. HbA1c was 7.5%~11.0% (both inclusive);

5. Body Mass Index (BMI) ≥22 kg/m2 at screening.

Exclusion criteria

1. A history of type 1 diabetes, specific diabetes, or secondary diabetes;

2. Have a history of severe hypoglycemia within t180 days prior to screening;

3. History of acute cardiovascular and cerebrovascular diseases within 180 days prior to screening;

4. Have a history of malignancy within 5 years;

5. Known or suspected allergy or intolerance to the investigational medicinal products or related products;

6. Participation in any clinical trial of an approved or non-approved investigational product/treatment within the last 90 days;

7. Any conditions that the Investigator judges might not be suitable to participate in the trial.

Endpoints (5)

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
4
Patient-reported / QoL
1

Glycemic / diabetes

4 endpoints
Primary/protocol endpoint

Change in HbA1c

Time frame:from baseline to Week 40

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Proportion of subjects reaching HbA1<7.0%

Time frame:from baseline to Week 40

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Proportion of subjects reaching HbA1≤6.5%

Time frame:from baseline to Week 40

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in FPG

Time frame:from baseline to Week 40

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Patient-reported / QoL

1 endpoint
Secondary/protocol endpoint

Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) Score

Time frame:From baseline to Week 40

change from baseline, improvement

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.