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NCT Number: NCT07559136

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

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

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Key information

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location contact

Xiaoping Luo

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HRS9531 injection;Placebo

Drug

Drug: HRS9531 injection; low dose Drug: Placebo

Primary outcomes

  1. Adverse Events (AEs)

    Time frame: up to Week 28

Secondary outcomes

  1. Maximum concentration (Cmax) of HRS9531

    Time frame: up to Week 28

  2. Trough concentration (Ctrough) of HRS9531

    Time frame: up to Week 28

  3. Area under the curve from time zero to end of dosing interval (AUC0-tau)

    Time frame: up to Week 28

  4. Changes from baseline in BMI

    Time frame: up to Week 24

  5. Change from baseline in body weight

    Time frame: up to Week 24

  6. Change from baseline in waist circumference

    Time frame: up to Week 24

  7. Anti-HRS9531 antibodies (ADA)

    Time frame: up to Week 28

Study contacts

Contact information is provided by the study sponsor or research team.

Shujin Cheng

CONTACT

[email protected]

+86-0518-82342973

Sponsors and collaborators

Lead sponsor

Fujian Shengdi Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 30, 2026
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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