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the Efficacy and Safety of HRS9531 Injection in Subjects With Type 2 Diabetes, Inadequately Controlled With Diet and Exercise Alone
A Multicenter, Randomized, Double-blind, Placebo- Parallel Controlled, Phase III Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Subjects With Type 2 Diabetes, Inadequately Controlled With Diet and Exercise Alone
Lead sponsor
Asset
HRS9531
Subcutaneous · GLP-1 / GIP dual
Listed sites
1
Recruiting sites
—
Enrollment
218
actual
Study population
Type 2 diabetes
Key I/E criterion
•HbA1c ≤10%
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. Males and females, Age ≥18 years at the time of signing informed consent.
2. Diagnosed with type 2 diabetes mellitus (T2DM) for at least 90 days prior to day of screening.
3. Treatment with Diet and Exercise alone at least 90 days prior to day of screening.
4. 7.5% ≤ HbA1c ≤10.0% at screening.
Exclusion criteria
1. Uncontrollable hypertension(with or without antihypertensive treatment) : systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg at screening.
2. Diagnosed or suspected with type 1 diabetes mellitus, special types of diabetes or secondary diabetes.
3. History of significant hematological disorders (e.g., sickle cell disease, hemolytic anemia, myelodysplastic syndrome, etc.) or other conditions causing hemolysis or instability of red blood cells (e.g., malaria, hypersplenism, etc.).
4. Presence of an endocrine disorder or history that may significantly affect bady weight(e.g., Cushing's syndrome, hypothyroidism or hyperthyroidism, except hypothyroidism if thyroid hormone replacement dose has been stable for at least 6 months) ;
5. Severe infection, severe trauma, or moderate-to-major surgery within 1 month before screening.
6. Participated in clinical trials of any drug or medical device within 3 months prior to screening, and participation in clinical trials is defined as signing informed consent and using investigational drugs (including placebo) or investigational medical devices; Or is still in the trial drug within 5 half-lives (whichever is Longer).
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
Weight & body composition
1 endpointChange in body weight
Time frame:from baseline to 36 weeks treatment
Body weight, absolute change (kg)
change from baseline, improvement
Glycemic / diabetes
4 endpointsChange in HbA1c
Time frame:from baseline to 36 weeks treatment
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Proportion of subjects with HbA1c<7.0% and ≤6.5%
Time frame:from baseline to 36 weeks treatment
HbA1c <7.0% achievement
threshold achievement, improvement
LOINC 4548-4
Change in FPG
Time frame:from baseline to 36 weeks treatment
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Proportion of subjects with HbA1c<7.0% and weight loss ≥5%
Time frame:from baseline to 36 weeks treatment
threshold achievement, improvement
componentsHbA1c <7.0% achievement, ≥5% weight-loss responders
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.