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Efficacy and Safety of HRS9531 Injection in Obese Subjects Without Diabetes
A Multicenter, Randomized, Double-blind, Placebo- Parallel Controlled, Phase II Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Obese Subjects Without Diabetes
Lead sponsor
Asset
HRS9531
Subcutaneous · GLP-1 / GIP dual
Listed sites
26
Recruiting sites
—
Enrollment
249
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. At screening visit, 28.0 ≤BMI≤ 40.0 kg/m2;
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. Uncontrollable hypertension;
3. PHQ-9 score ≥15;
4. Medical history or illness that affects your 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 within 6 months prior to screening;
8. Any organ-system malignancies developed within 5 years except for cured local basal cell cancer of the skin and in-situ cancer of the cervix;
9. Confirmed or suspected depression, bipolar disorder, suicidal tendencies, schizophrenia, or other serious mental illness;
10. History of alcohol and/or substance abuse or drug abuse within 1 year prior to screening;
11. Use of any medication or treatment that may have caused significant weight change within 3 months;
12. History of bariatric surgery;
13. Known or suspected hypersensitivity to trial product(s) or related products;
14. Participation in other clinical trials for any weight-loss indication within 3 months prior to screening, or participation in other clinical trials for any drug or medical device within 1 month prior to screening;
15. history of blood donation or blood loss in the 3 months before screening, or blood transfusion in the 2 months before screening;
16. Surgery is planned during the trial;
17. Mentally incapacitated or speech-impaired;
18. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method;
19. Researchers and relevant staff of the research Centre or other people directly involved in the implementation of the programme, and their immediate family members.
Endpoints (21)
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
12 endpointsPercentage change in body weight
Time frame:Week 0, Week 24
Body weight, % change
percent change from baseline, improvement
Proportion of subjects with weight loss of ≥5% from baseline in body weight after 24 weeks of treatment
Time frame:Week 24
≥5% weight-loss responders
threshold achievement, improvement
Proportion of subjects with weight loss of ≥10% from baseline in body weight after 24 weeks of treatment
Time frame:Week 24
≥10% weight-loss responders
threshold achievement, improvement
Change from baseline in body weight after 24 weeks of treatment
Time frame:Week 0, Week 24
Body weight, absolute change (kg)
change from baseline, improvement
Change from baseline in waist circumference after 24 weeks of treatment
Time frame:Week 0, Week 24
Waist circumference, change
change from baseline, improvement
Change from baseline in BMI after 24 weeks of treatment
Time frame:Week 0, Week 24
BMI, change
change from baseline, improvement
Percentage change in body weight
Time frame:Week 0, Week 32
Body weight, % change
percent change from baseline, improvement
Proportion of Subjects with weight loss of ≥5% from baseline in body weight after 32 weeks of treatment
Time frame:Week 32
≥5% weight-loss responders
threshold achievement, improvement
Proportion of Subjects with weight loss of ≥10% from baseline in body weight after 32 weeks of treatment
Time frame:Week 32
≥10% weight-loss responders
threshold achievement, improvement
Change from baseline in body weight after 32 weeks of treatment
Time frame:Week 0, Week 32
Body weight, absolute change (kg)
change from baseline, improvement
Change from baseline in waist circumference after 32 weeks of treatment
Time frame:Week 0, Week 32
Waist circumference, change
change from baseline, improvement
Change from baseline in BMI after 32 weeks of treatment
Time frame:Week 0, Week 32
BMI, change
change from baseline, improvement
Glycemic / diabetes
4 endpointsChange from baseline in fasting plasma glucose (FPG) after 24 weeks of treatment
Time frame:Week 0, Week 24
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Change from baseline in glycosylated haemoglobin (HbA1c) after 24 weeks of treatment
Time frame:Week 0, Week 24
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Change from baseline in fasting plasma glucose (FPG) after 32 weeks of treatment
Time frame:Week 0, Week 32
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Change from baseline in glycosylated haemoglobin (HbA1c) after 32 weeks of treatment
Time frame:Week 0, Week 32
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Cardiometabolic biomarkers
4 endpointsChange from baseline in blood pressure after 24 weeks of treatment
Time frame:Week 0, Week 24
change from baseline, improvement
Change from baseline in total cholesterol after 24 weeks of treatment
Time frame:Week 0, Week 24
Total cholesterol, change
change from baseline, improvement
LOINC 2093-3
Change from baseline in blood pressure after 32 weeks of treatment
Time frame:Week 0, Week 32
change from baseline, improvement
Change from baseline in total cholesterol after 32 weeks of treatment
Time frame:Week 0, Week 32
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 56
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.