← Trials/Trial dossier/NCT07559136

Not yet recruitingPhase 1

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

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

NCT IDNCT07559136
Org study IDHRS9531-111

Timeline

Milestones

Study first posted2026-04-30actual
Last update posted2026-04-30actual
Study start2026-05estimated (month precision)
Primary completion2027-01estimated (month precision)
Study completion2027-02estimated (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age12 Years
Maximum age18 Years
SexAll
Healthy volunteersNot accepted

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

Safety / tolerability / PK
5
Weight & body composition
3

Weight & body composition

3 endpoints
Secondary/protocol endpoint

Changes from baseline in BMI

Time frame:up to Week 24

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in body weight

Time frame:up to Week 24

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in waist circumference

Time frame:up to Week 24

Waist circumference, change

change from baseline, improvement

Safety / tolerability / PK

5 endpoints
Primary/protocol endpoint

Adverse Events (AEs)

Time frame:up to Week 28

Treatment-emergent AEs (any)

descriptive, event

Secondary/protocol endpoint

Maximum concentration (Cmax) of HRS9531

Time frame:up to Week 28

Cmax

concentration, descriptive

Secondary/protocol endpoint

Trough concentration (Ctrough) of HRS9531

Time frame:up to Week 28

Plasma concentration (steady state)

concentration, descriptive

Secondary/protocol endpoint

Area under the curve from time zero to end of dosing interval (AUC0-tau)

Time frame:up to Week 28

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Anti-HRS9531 antibodies (ADA)

Time frame:up to Week 28

Immunogenicity (ADA)

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.