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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.
Lead sponsor
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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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 endpointsChange in HbA1c
Time frame:from baseline to Week 40
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Proportion of subjects reaching HbA1<7.0%
Time frame:from baseline to Week 40
HbA1c <7.0% achievement
threshold achievement, improvement
LOINC 4548-4
Proportion of subjects reaching HbA1≤6.5%
Time frame:from baseline to Week 40
HbA1c <6.5% achievement
threshold achievement, improvement
LOINC 4548-4
Change in FPG
Time frame:from baseline to Week 40
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Patient-reported / QoL
1 endpointChange in Diabetes Treatment Satisfaction Questionnaire (DTSQ) Score
Time frame:From baseline to Week 40
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.