Clinical trial

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

Recruiting now · Phase 1 · 1 countries · Registry ID NCT07559136

Recruiting nowPhase 1Interventional

What this study is about

The aim of this trial is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS9531 injection compared with placebo in adolescents with obesity

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age12 Years to 18 Years
SexAll
Healthy volunteersNot accepted
ConditionOverweight and Obesity

Full registry 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.

Treatments and study arms

HRS9531 injection;Placebo

Drug

Drug: HRS9531 injection; low dose Drug: Placebo

HRS9531 injection;Placebo

Drug

Drug: HRS9531 injection; medium dose Drug: Placebo

HRS9531 injection;Placebo

Drug

Drug: HRS9531 injection; high dose Drug: Placebo

Primary outcomes

Adverse Events (AEs)up to Week 28

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology🇨🇳 Wuhan, Hubei, China
Xiaoping LuoPrincipal Investigator