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A Study of HRS-7535 Compared With Dapagliflozin in Adult Participants With Type 2 Diabetes and Inadequately Controlled With Metformin
A Phase 3, Randomized, Double-blinded Study to Evaluate the Efficacy and Safety of HRS-7535 Compared With Dapagliflozin in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin (OUTSTAND-2)
Lead sponsor
Asset
KAI-7535 / HRS-7535
Oral · GLP-1 agonist
Listed sites
1
Recruiting sites
1
Enrollment
800
estimated
Study population
Type 2 diabetes
Key I/E criterion
•HbA1c 7.5-11%
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, 18-75 age years, both inclusive;
2. Type 2 diabetes mellitus diagnosed for at least 3 months before the screening visit;
3. HbA1c 7.5-11.0% (both inclusive) at screening;
4. Treated with conventional lifestyle intervention and stable treatment with metformin (≥1500 mg/day) at least 8 weeks prior to screening.
Exclusion criteria
1. Known or suspected allergy to the investigational drug or its components or excipients.
2. Diagnosed or suspected with type 1 diabetes mellitus, special types of diabetes or secondary diabetes.
3. Have a history of acute complications of diabetes (diabetic ketoacidosis, lactic acidosis, hyperglycaemic hyperosmolar state, etc.) within 6 months prior to screening.
4. Proliferative retinopathy, maculopathy, painful diabetic neuropathy, diabetic foot ulcer or intermittent claudication requiring acute treatment;
5. Pregnancy, breast-feeding, intention of becoming pregnant during the trial; or women of childbearing potential (WOCBP) or male subject not using adequate contraceptive measures.
Endpoints (7)
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
3 endpointsPercentage Change from Baseline in Body Weight, from Baseline to Week 32
Time frame:at 32 weeks
percent change from baseline, improvement
Change from Baseline in Body Weight, from Baseline to Week 32
Time frame:at 32 weeks
change from baseline, improvement
Change from Baseline in Waist Circumference, from Baseline to Week 32
Time frame:at 32 weeks
change from baseline, improvement
Glycemic / diabetes
4 endpointsChange from baseline in HbA1c at 32 weeks of treatment
Time frame:at 32 weeks
change from baseline, improvement
Percentage of Participants Who Achieved HbA1c <7.0% at Week 32
Time frame:at 32 weeks
threshold achievement, improvement
Percentage of Participants Who Achieved HbA1c ≤6.5% at Week 32
Time frame:at 32 weeks
threshold achievement, improvement
Change from Baseline in Fasting Serum Glucose, from Baseline to Week 32
Time frame:at 32 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.