A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS9531 Injection in Adolescents With Obesity

Korábbi kezelés

• Acute infection, acute trauma, or medium to large surgery within 1 month prior to screening;
• Use of drugs or treatments that may have caused significant weight gain or loss within the 3 months prior to screening;
• Patients with blood donation or blood loss ≥400 mL or receiving blood transfusion within 3 months before screening.
• Surgery is planned during the tria;

Más betegség

• Uncontrollable hypertension;
• Medical history or illness that affects your weight;
• History of diabetes;
• Confirmed or suspected depression, bipolar disorder, suicidal tendencies, schizophrenia, or other serious mental illness;
• 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.

Egyéb

• Presence of clinically significant lab results at screening visit;
• Pre-adolescent participants (Tanner phase I);
• Mentally incapacitated or speech-impaired subjects are unable to fully understand or participate in the test process；

• Male or female subjects who are aged ≥12 years and \<18 years at the time of signing the informed consent;
• 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";
• 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);