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HRS9531 Controls Weight Regain in Obese Subjects
A Single-center, Double-blinded, Randomized, Placebo-controlled Trial to Evaluate the Effectiveness and Safety of Low-frequency Injection of HRS9531 in Control of Weight Regain in Obese Subjects With and Without Diabetes
Lead sponsor
Asset
HRS9531
Subcutaneous · GLP-1 / GIP dual
Listed sites
1
Recruiting sites
—
Enrollment
72
estimated
Study population
Obesity / overweight
Key I/E criteria
•BMI 30-40•HbA1c 7-10%
Primary endpoint
•Body weight, % 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. 30-60 years old, female and male.
2. BMI:30-40kg/m2.
3. Non diabetes or type 2 diabetes with HbA1c between 7-10%.
Exclusion criteria
1. Weight change ≤5 kg within 3 months.
2. Hb<110g/L.
3. Serum triglycerides 5.7 mmol/L.
4. Impaired liver function ：ALT or AST≥3×ULN，TB≥2×ULN.
5. Impaired renal function：eGFT < 45 ml/min.
6. Hemodiastase or Serum lipase≥3×ULN.
7. TSH>6.0 mIU/L or<0.4 mIU/L.
8. Systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg.
9. lth Questionnaire-9 (PHQ-9) score ≥15.
10. Type 1 diabetes.
11. Proliferative diabetic retinopathy, ketoacidosis or hyperglycemia hypertonic state within 3 months.
12. In the investigator's judgment, there were circumstances that affected subject safety or otherwise interfered with the evaluation of results.
Endpoints (17)
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
4 endpointsPercent Change in Body Weight from 24 weeks
Time frame:36 weeks
Body weight, % change
percent change from baseline, improvement
Body fat rate change from 24 weeks
Time frame:24-36 weeks
Total fat mass
change from baseline, improvement
Percent Change in Body Weight at 24 weeks
Time frame:24 weeks
Body weight, % change
percent change from baseline, improvement
Change of body weight at 24 weeksl from baseline
Time frame:24 weeks
Body weight, absolute change (kg)
change from baseline, improvement
Cardiometabolic biomarkers
4 endpointsSystolic blood pressure and diastolic blood pressure change from 24 weeks
Time frame:24-36 weeks
change from baseline, improvement
componentsSystolic BP, change, Diastolic BP, change
Serum total cholesterol change from 24 weeks
Time frame:24-36 weeks
Total cholesterol, change
change from baseline, improvement
LOINC 2093-3
Triglyceride change from 24 weeks
Time frame:24-36 weeks
Triglycerides, change
change from baseline, improvement
LOINC 2571-8
Nonestesterified fatty acid change from 24 weeks
Time frame:24-36 weeks
Free fatty acids, change
change from baseline, improvement
Patient-reported / QoL
2 endpointsAppetite at baseline (assessed by Visual Analogue Scale subjective rating scale)
Time frame:0 weeks
descriptive
Appetite at 24 weeks (assessed by Visual Analogue Scale subjective rating scale)
Time frame:24 weeks
change from baseline, improvement
Other (unclassified)
7 endpointsEnergy intake change from 24 weeks
Time frame:24-36 weeks
change from baseline, improvement
Energy expenditure change from 24 weeks
Time frame:24-36 weeks
change from baseline, descriptive
Metabolic adaptation from 24 weeks
Time frame:24-36 weeks
change from baseline, improvement
Energy intake at baseline
Time frame:0 weeks
descriptive
Energy expenditure at baseline
Time frame:0 weeks
descriptive
Energy expenditure at 24 weeks
Time frame:24 weeks
change from baseline, descriptive
Energy intake at 24 weeks
Time frame:24 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.