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

NCT07559136 | Not Yet Recruiting Phase 1

• 1 other identifier: HRS9531-111
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Overweight and Obesity

Outcome Measures

Primary Outcomes (1)

• Adverse Events (AEs)

  up to Week 28

Secondary Outcomes (7)

• 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

Study Arms (3)

Treatment group A: HRS9531 injection or Placebo

EXPERIMENTAL

Drug: HRS9531 injection；Placebo

Treatment group B: HRS9531 injection or Placebo

EXPERIMENTAL

Drug: HRS9531 injection；Placebo

Treatment group C: HRS9531 injection or Placebo

EXPERIMENTAL

Drug: HRS9531 injection；Placebo

Interventions

HRS9531 injection；Placebo DRUG

Drug: HRS9531 injection; low dose Drug: Placebo

Treatment group A: HRS9531 injection or Placebo

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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);

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fujian Shengdi Pharmaceutical Co., Ltd.: lead

Study Sites (1)

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

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Shujin Cheng

CONTACT

+86-0518-82342973; shujin.cheng@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2026
• First Posted: April 30, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

CN (1)