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Recruiting NCT07559136

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

Phase I Interventional Overweight and Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HRS9531 injection；Placebo, HRS9531 injection；Placebo, HRS9531 injection；Placebo.
Who it may be relevant to
Registry conditions: Overweight and Obesity. Basic parameters: 12 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Randomised, Double-blind, Placebo-controlled Trial to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Dosing of HRS9531 Injection in Chinese Adolescents With Obesity

Overview

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

Interventions

  • Drug HRS9531 injection；Placebo
    Drug: HRS9531 injection; low dose Drug: Placebo
  • Drug HRS9531 injection；Placebo
    Drug: HRS9531 injection; medium dose Drug: Placebo
  • Drug HRS9531 injection；Placebo
    Drug: HRS9531 injection; high dose Drug: Placebo

Primary outcome measures

  • Adverse Events (AEs) [Time frame: up to Week 28]
Secondary outcome measures (7)
  • Maximum concentration (Cmax) of HRS9531 [Time frame: up to Week 28]
  • Trough concentration (Ctrough) of HRS9531 [Time frame: up to Week 28]
  • Area under the curve from time zero to end of dosing interval (AUC0-tau) [Time frame: up to Week 28]
  • Changes from baseline in BMI [Time frame: up to Week 24]
  • Change from baseline in body weight [Time frame: up to Week 24]
  • Change from baseline in waist circumference [Time frame: up to Week 24]
  • Anti-HRS9531 antibodies (ADA) [Time frame: up to Week 28]

Eligibility criteria

Inclusion criteria

  • 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);

Exclusion criteria

  • Presence of clinically significant lab results at screening visit;
  • Uncontrollable hypertension;
  • Medical history or illness that affects your weight;
  • History of diabetes;
  • Acute infection, acute trauma, or medium to large surgery within 1 month prior to screening;
  • Confirmed or suspected depression, bipolar disorder, suicidal tendencies, schizophrenia, or other serious mental illness;
  • Use of drugs or treatments that may have caused significant weight gain or loss within the 3 months prior to screening;
  • Pre-adolescent participants (Tanner phase I);
  • Patients with blood donation or blood loss ≥400 mL or receiving blood transfusion within 3 months before screening.
  • Surgery is planned during the tria;
  • Mentally incapacitated or speech-impaired subjects are unable to fully understand or participate in the test process；
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan

Identifiers

NCT: NCT07559136 · HRS9531-111

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗