Overweight and Obesity
Conditions
Brief summary
The aim of this trial is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS9531 injection compared with placebo in adolescents with obesity
Interventions
DRUGHRS9531 injection；Placebo
Drug: HRS9531 injection; low dose Drug: Placebo
Sponsors
Fujian Shengdi Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Events (AEs) | up to Week 28 |
Secondary
| Measure | Time frame |
|---|---|
| Maximum concentration (Cmax) of HRS9531 | up to Week 28 |
| Trough concentration (Ctrough) of HRS9531 | up to Week 28 |
| Area under the curve from time zero to end of dosing interval (AUC0-tau) | up to Week 28 |
| Changes from baseline in BMI | up to Week 24 |
| Change from baseline in body weight | up to Week 24 |
| Change from baseline in waist circumference | up to Week 24 |
| Anti-HRS9531 antibodies (ADA) | up to Week 28 |
Countries
China
Contacts
CONTACTShujin Cheng
Outcome results
None listed