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Efficacy and Safety of HRS9531 Injections in Overweight or Obese Subjects
A Multicenter, Randomized, Double-blind, Placebo-parallel-controlled, Phase II Clinical Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Overweight or Obese Subjects
Lead sponsor
Asset
HRS9531
GLP-1 / GIP dual
Listed sites
4
Recruiting sites
—
Enrollment
61
actual
Study population
Obesity / overweight
Key I/E criterion
•BMI ≤40
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. Able and willing to provide a written informed consent.
2. Male or female subjects, 18-65 years of age at the time of signing informed consent.
3. 28.0 ≤BMI≤ 40.0 kg/m2 or 24 ≤BMI< 28.0 kg/m2 with at least 1 weight-related comorbidity at screening visit.
4. Diet and exercise control for at least 3 months before screening visit, and less than 5 kg self-reported change within the last 3 months.
Exclusion criteria
1. Presence of - clinically significant lab or ECG results that may affect the evaluation of the efficacy or safety of the study drug at screening visit.
2. poor-controlled hypertension.
3. PHQ-9 score ≥15.
4. Medical history of illness that affects weight.
5. History of diabetes.
6. Acute infection, acute trauma, or medium to large surgery within 1 month prior to screening.
7. History of acute cardiovascular and cerebrovascular diseases.
8. Any organ-system malignancies developed within 5 years except cured local basal cell carcinoma of skin and cervical carcinoma in situ.
9. Confirmed or suspected depression, bipolar disorder, suicidal tendency, schizophrenia, or other serious mental illness.
10. History of alcohol , medication or drug abuse within 1 year prior to screening.
11. Use of any medication or treatment that may cause significant weight change within 3 months.
12. History of bariatric surgery.
13. Subjects participating in QT/QTc studies need to comply with relevant examinations.
14. Known or suspected hypersensitivity to trial product(s) or related products.
15. Participation in other clinical trials within 3 month prior to screening.
16. History of blood donation or blood loss in the 3 months before screening, or blood transfusion in the 2 months before screening
17. Surgery is planned during the trial.
18. Mentally incapacitated or speech-impaired.
19. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method.
20. Researchers and relevant staff of the research Centre or other people directly involved in the implementation of the programme, and their immediate family members.
21. In the judgment of the investigator, there are circumstances that affect the safety of the subject or any other interference with the evaluation of the test results.
Endpoints (12)
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
7 endpointsPercentage change in body weight
Time frame:Week 0, Week 36
Body weight, % change
percent change from baseline, improvement
Proportion of Subjects with weight loss of ≥5% from baseline in body weight after 36 weeks of treatment
Time frame:Week 36
≥5% weight-loss responders
threshold achievement, improvement
Proportion of Subjects with weight loss of ≥10% from baseline in body weight after 36 weeks of treatment
Time frame:Week 36
≥10% weight-loss responders
threshold achievement, improvement
Proportion of Subjects with weight loss of ≥15% from baseline in body weight after 36 weeks of treatment
Time frame:Week 36
≥15% weight-loss responders
threshold achievement, improvement
Change from baseline in body weight after 36 weeks of treatment
Time frame:Week 0, Week 36
Body weight, absolute change (kg)
change from baseline, improvement
Change from baseline in waist circumference after 36 weeks of treatment
Time frame:Week 0, Week 36
Waist circumference, change
change from baseline, improvement
Change from baseline in BMI after 36 weeks of treatment
Time frame:Week 0, Week 36
BMI, change
change from baseline, improvement
Glycemic / diabetes
2 endpointsChange from baseline in fasting plasma glucose (FPG) after 36 weeks of treatment
Time frame:Week 0, Week36
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Change from baseline in glycosylated haemoglobin (HbA1c) after 36 weeks of treatment
Time frame:Week 0, Week 36
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Cardiometabolic biomarkers
2 endpointsChange from baseline in blood pressure after 36 weeks of treatment
Time frame:Week 0, Week 36
change from baseline, improvement
Change from baseline in total cholesterol after 36 weeks of treatment
Time frame:Week 0, Week 36
Total cholesterol, change
change from baseline, improvement
LOINC 2093-3
Safety / tolerability / PK
1 endpointNumber 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.