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CompletedPhase 2

Efficacy and Safety of HRS-7535 Tablets in T2DM Subjects Poorly Controlled With Metformin and SGLT2i.

A Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel-group Phase ⅡStudy to Evaluate the Efficacy and Safety of HRS-7535 in T2DM Subjects Poorly Controlled With Metformin and SGLT2i.

Asset

KAI-7535 / HRS-7535

Oral · GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

155

actual

Study population

Type 2 diabetes

Key I/E criteria

BMI ≤35HbA1c ≤11%

Primary endpoint

HbA1c

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 IDNCT06393348
Org study IDHRS-7535-205

Timeline

Milestones

Study first posted2024-05-01actual
Study start2024-05-17actual
Primary completion2024-11-15actual
Study completion2025-03-13actual
Last update posted2025-12-05actual

Assets

Investigational agents

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Male or female subjects, 18-75 years of age at the time of signing informed consent;

2. Have T2DM (based on the 2020 Chinese Diabetes Society [CDS] diagnostic criteria)

3. HbA1c为7.5%≤HbA1c≤11.0% at the screening visit;

4. FPG≤15 mmol/L at the screening visit;

5. Have been treated with an SGLT2i with metformin, for at least 8 weeks;

6. At screening and random visit, 20.0 ≤BMI≤ 35.0 kg/m2;

7. Able and willing to provide a written informed consent

Exclusion criteria

1. Have type 1 diabetesmellitus;

2. History of acute cardiovascular and cerebrovascular diseases within 6 months prior to screening;

3. Any organ-system malignancies developed within 5 years except for cured local basal cell cancer of the skin and in-situ cancer of the cervix;

4. history of blood donation or blood loss in the 3 months before screening, or blood transfusion in the 2 months before screening;

5. Surgery is planned during the trial;

6. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method;

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
4
Weight & body composition
1
Other (unclassified)
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

The change in in body weight from baseline to 16 weeks

Time frame:16 weeks

change from baseline, improvement

Glycemic / diabetes

4 endpoints
Primary/protocol endpoint

Change in HbA1c from baseline at Week 16

Time frame:Week 16

change from baseline, improvement

Secondary/protocol endpoint

Proportion of subjects achieving HbA1c target of <7.0% at 16 weeks

Time frame:16 weeks

threshold achievement, improvement

Secondary/protocol endpoint

Proportion of subjects achieving HbA1c target of ≤6.5% at 16 weeks

Time frame:16 weeks

threshold achievement, improvement

Secondary/protocol endpoint

The change in fasting blood glucose from baseline to 16 weeks

Time frame:16 weeks

change from baseline, improvement

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

The change in 7-point SMBG profile from baseline to 16 weeks

Time frame:16 weeks

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.