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

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age12-18
SponsorFujian Shengdi Pharmaceutical Co., Ltd.

About this trial

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 criteria

Qualifiers

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);

Disqualifiers

Presence of clinically significant lab results at screening visit;

Uncontrollable hypertension;

Medical history or illness that affects your weight;

History of diabetes;

Trial design

Treatments tested in this trial

  • HRS9531 injection;Placebo
  • HRS9531 injection;Placebo
  • HRS9531 injection;Placebo

Treatment groups

48 Participants
are divided into 3 treatment groups