Sign in

NCT07559136Active, not recruitingPhase 1

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

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

Source: ClinicalTrials.gov · Last updated 28 Sept 2026

Brief summary (registry, in English)

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

Status (registry)
Active, not recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
48 (actual)
First submitted
23 Apr 2026
Start date
12 Jun 2026
Primary completion date
28 Feb 2027
Lead sponsor
Fujian Shengdi Pharmaceutical Co., Ltd.
Diseases
Obesity
NCT number
NCT07559136

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 48
  • From 12 Jun 2026 to the primary completion date, 28 Feb 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Acute infection, acute trauma, or medium to large surgery within 1 month prior to screening;
  • Use of drugs or treatments that may have caused significant weight gain or loss within the 3 months prior to screening;
  • Patients with blood donation or blood loss ≥400 mL or receiving blood transfusion within 3 months before screening.
  • Surgery is planned during the tria;

Other illness

  • Uncontrollable hypertension;
  • Medical history or illness that affects your weight;
  • History of diabetes;
  • Confirmed or suspected depression, bipolar disorder, suicidal tendencies, schizophrenia, or other serious mental illness;
  • 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.

Other

  • Presence of clinically significant lab results at screening visit;
  • Pre-adolescent participants (Tanner phase I);
  • Mentally incapacitated or speech-impaired subjects are unable to fully understand or participate in the test process;

Who the study is looking for

  • 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);

Age in the registry: 12 years to 18 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Coordinator of this site? Confirm its status
WuhanChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.