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Efficacy and Safety of HRS9531 Injection in Type 2 Diabetes Subjects
A Multi-center, Randomized, Double-blind, Placebo- Parallel Controlled, Phase II Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Type 2 Diabetes Subjects
Lead sponsor
Asset
HRS9531
GLP-1 / GIP dual
Listed sites
1
Recruiting sites
—
Enrollment
199
actual
Study population
Type 2 diabetes
Key I/E criterion
•HbA1c 7.5-10.5%
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 subjects ,18-65 years of age, agreed and signed the informed consent
2. Type 2 diabetes mellitus diagnosed for at least 6 months before the screening visit.
3. Treated with conventional lifestyle intervention and stable treatment with metformin (≥1000 mg/day) at least 8 weeks prior to screening.
4. HbA1c 7.5-10.5% (both inclusive) at screening visit.
Exclusion criteria
1. Presence of any clinically significant results in examination at screening visit.
2. Uncontrollable hypertension.
3. A history of type 1 diabetes, specific diabetes, or secondary diabetes.
4. Acute diabetic complications or severe hypoglycemia events within 12 months prior to screening.
5. History of acute cardiovascular and cerebrovascular diseases within 6 months prior to screening.
6. Any organ-system malignancies developed within 5 years except for cured local basal cell carcinoma of the skin and carcinoma in situ of the cervix.
7. Present or suspected depression, bipolar disorder, suicidal tendencies, schizophrenia, or other more serious mental illness.
8. Surgery is planned during the trial.
9. Mentally incapacitated or speech-impaired.
10. Pregnant or lactating woman.
11. In the investigator's judgment, there were circumstances that affected subject safety or otherwise interfered with the evaluation of results.
Endpoints (10)
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
2 endpointsChange from baseline body Weight and waist circumference after 20 weeks of treatment
Time frame:Week 0 to Week 20
change from baseline, improvement
componentsBody weight, absolute change (kg), Waist circumference, change
Change from baseline in body Weight and waist circumference after 32 weeks of treatment
Time frame:Week 0 to Week 32
change from baseline, improvement
componentsBody weight, absolute change (kg), Waist circumference, change
Glycemic / diabetes
6 endpointsChange From Baseline in HbA1c after 20 weeks of treatment
Time frame:Week 0 to Week 20
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Proportion of subjects reaching HbA1c targets (HbA1c<7.0%) after 20 weeks of treatment
Time frame:Week 0 to Week 20
HbA1c <7.0% achievement
threshold achievement, improvement
LOINC 4548-4
Proportion of subjects reaching HbA1c targets (HbA1c<7.0%) after 32 weeks of treatment
Time frame:Week 0 to Week 32
HbA1c <7.0% achievement
threshold achievement, improvement
LOINC 4548-4
Change From Baseline in HbA1c after 32 weeks
Time frame:Week 0 to Week 32
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Change from baseline in fasting plasma glucose (FPG), serum insulin and C-peptide after 20 weeks of treatment
Time frame:Week 0 to Week 20
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Change from baseline in fasting plasma glucose (FPG), serum insulin and C-peptide after 32 weeks of treatment
Time frame:Week 0 to Week 32
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Safety / tolerability / PK
2 endpointsNumber of Participants With Anti-HRS9531 Antibody
Time frame:Week 0 to Week 36
Immunogenicity (ADA)
threshold achievement, event
Number of AEs During the Trial
Time frame:Week 0 to Week 36
Treatment-emergent AEs (any)
event count, event
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.