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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.
Lead sponsor
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 ≤35•HbA1c ≤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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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
Weight & body composition
1 endpointThe change in in body weight from baseline to 16 weeks
Time frame:16 weeks
change from baseline, improvement
Glycemic / diabetes
4 endpointsChange in HbA1c from baseline at Week 16
Time frame:Week 16
change from baseline, improvement
Proportion of subjects achieving HbA1c target of <7.0% at 16 weeks
Time frame:16 weeks
threshold achievement, improvement
Proportion of subjects achieving HbA1c target of ≤6.5% at 16 weeks
Time frame:16 weeks
threshold achievement, improvement
The change in fasting blood glucose from baseline to 16 weeks
Time frame:16 weeks
change from baseline, improvement
Other (unclassified)
1 endpointThe change in 7-point SMBG profile from baseline to 16 weeks
Time frame:16 weeks
change from baseline, improvement
Provenance
Sources
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.