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A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS9531 Injection in Adolescents With Obesity
A Randomised, Double-blind, Placebo-controlled Trial to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Dosing of HRS9531 Injection in Chinese Adolescents With Obesity
Lead sponsor
Asset
HRS9531
GLP-1 / GIP dual
Listed sites
1
Recruiting sites
—
Enrollment
48
estimated
Study population
Obesity / overweight
Key I/E criterion
•BMI 586-2018
Primary endpoint
•Treatment-emergent AEs (any)
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 who are aged ≥12 years and <18 years at the time of signing the informed consent;
2. At screening, the BMI meets the obesity criteria according to "WS/T586-2018 Screening Criteria for Overweight and Obesity in School-age Children and Adolescents";
3. Subjects who have maintained a controlled diet and exercise for at least 12 weeks prior to screening, with no more than a 5% decrease in BMI (as reported by the subject, parent, or legal guardian);
Exclusion criteria
1. Presence of clinically significant lab results at screening visit;
2. Uncontrollable hypertension;
3. Medical history or illness that affects your weight;
4. History of diabetes;
5. Acute infection, acute trauma, or medium to large surgery within 1 month prior to screening;
6. Confirmed or suspected depression, bipolar disorder, suicidal tendencies, schizophrenia, or other serious mental illness;
7. Use of drugs or treatments that may have caused significant weight gain or loss within the 3 months prior to screening;
8. Pre-adolescent participants (Tanner phase I);
9. Patients with blood donation or blood loss ≥400 mL or receiving blood transfusion within 3 months before screening.
10. Surgery is planned during the tria;
11. Mentally incapacitated or speech-impaired subjects are unable to fully understand or participate in the test process;
12. In the investigator's judgment, there are circumstances that affect subject safety or any other conditions that interfere with the evaluation of the test results.
Endpoints (8)
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
3 endpointsChanges from baseline in BMI
Time frame:up to Week 24
BMI, change
change from baseline, improvement
Change from baseline in body weight
Time frame:up to Week 24
Body weight, absolute change (kg)
change from baseline, improvement
Change from baseline in waist circumference
Time frame:up to Week 24
Waist circumference, change
change from baseline, improvement
Safety / tolerability / PK
5 endpointsAdverse Events (AEs)
Time frame:up to Week 28
Treatment-emergent AEs (any)
descriptive, event
Maximum concentration (Cmax) of HRS9531
Time frame:up to Week 28
Cmax
concentration, descriptive
Trough concentration (Ctrough) of HRS9531
Time frame:up to Week 28
Plasma concentration (steady state)
concentration, descriptive
Area under the curve from time zero to end of dosing interval (AUC0-tau)
Time frame:up to Week 28
AUC₀–∞
concentration, descriptive
Anti-HRS9531 antibodies (ADA)
Time frame:up to Week 28
Immunogenicity (ADA)
descriptive
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.