NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

NCT07559136

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