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A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS9531 Injection in Adolescents With Obesity
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS9531 Injection in Adolescents With Obesity
RecruitingPhase 1
Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.
Conditions: Overweight and Obesity
Interventions: HRS9531 injection;Placebo, HRS9531 injection;Placebo, HRS9531 injection;Placebo
Countries: China
The aim of this trial is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS9531 injection compared with placebo in adolescents with obesity
Eligibility overview
Sex: ALL
Age: 12 Years to 18 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
Eligibility criteria
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.
Locations (1)
- Wuhan, Hubei, China