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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Overweight and Obesity
• Intervention / Treatment: Drug: HRS9531 injection；Placebo; Drug: HRS9531 injection；Placebo; Drug: HRS9531 injection；Placebo

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group A: HRS9531 injection or Placebo	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
Experimental: Treatment group B: HRS9531 injection or Placebo	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
Experimental: Treatment group C: HRS9531 injection or Placebo	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Adverse Events (AEs)	up to Week 28

Secondary Outcome Measures

Outcome Measure	Time Frame
Maximum concentration (Cmax) of HRS9531	up to Week 28
Trough concentration (Ctrough) of HRS9531	up to Week 28
Area under the curve from time zero to end of dosing interval (AUC0-tau)	up to Week 28
Changes from baseline in BMI	up to Week 24
Change from baseline in body weight	up to Week 24
Change from baseline in waist circumference	up to Week 24
Anti-HRS9531 antibodies (ADA)	up to Week 28

Collaborators and Investigators

• Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: April 23, 2026
• First Submitted That Met QC Criteria: April 23, 2026
• First Posted (Actual): April 30, 2026

Study Record Updates

• Last Update Posted (Actual): September 28, 2026
• Last Update Submitted That Met QC Criteria: September 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity
• Other Study ID Numbers: HRS9531-111

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No