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Active, not recruiting Phase 3

A Study Comparing the Efficacy and Safety of HRS9531 Injection With Semaglutide Injection in Subjects With Obesity

NCT07285902 · tracked via the Priya Life Science China tracker
Phase
Phase 3
Started
2025-12-25
Last updated
2026-02-27

Condition(s) studied

Obesity

Investigational drug(s) / intervention(s)

HRS9531 injection →Semaglutide Injection →

HRS9531 injection: HRS9531 injection

Semaglutide Injection: Semaglutide Injection

Study summary

This study is a multicenter, randomized, open-label, parallel-controlled, phase III study to compare the efficacy, safety, and tolerability of HRS9531 versus semaglutide once weekly (QW) in adult subjects with obesity

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. With my consent and has signed the informed consent form, I am willing and able to follow the requirements of the trial protocol to complete this study; 2. Age ≥ 18 years old on the day of signing the informed consent, regardless of gender; 3. obesity 4. Self-reported diet and exercise control for 3 months or more before screening, and weight change of ≤ 5 kg in the past 3 months. 5. Male and female subjects of childbearing potential (including partners) who have no fertility plan and agree to take highly effective contraceptive measures within 2 months after signing the informed consent form to the last dose, and female or male subjects of childbearing potential have no plans to donate eggs/sperm; Female subjects of childbearing potential have a negative pregnancy test within 3 days prior to randomization and are not lactating. Exclusion Criteria: 1. Those with abnormal relevant examinations at screening; 2. ECG results are abnormal and may affect the safety of the subject 3. Poor blood pressure control 4. The PHQ-9 score ≥ 15 points 5. Presence or history of endocrine disorders that may significantly affect body weight 6. History of diabetes mellitus 7. Those who have had any previous disease or history that affects gastric emptying, or who have undergone gastrointestinal surgery 8. Previous or known history of acute or chronic pancreatitis, pancreatic injury; Patients with a history of acute cholecystitis or symptomatic/treatment-inducing gallbladder disease 9. Previous or known history or family history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia type 2 (MEN2). 10. Severe infection, severe trauma, or large and medium-sized surgery within 1 month prior to screening 11. History of severe cardiovascular and cerebrovascular diseases within the previous 6 months 12. Malignancy of any organ system within 5 years 13. Presence or suspicion of depression, bipolar disorder, suicidal tendencies, People with schizophrenia or other more serious mental illness 14. Known or suspected history of alcohol and/or drug abuse or drug abuse 15. Presence of a history of acute or chronic hepatitis or other serious liver disease other than non-alcoholic fatty liver disease 16. Presence of any hematologic disorder that may interfere with HbA1c detection 17. Presence of autoimmune disease with planned use of systemic glucocorticoids or immunosuppressive therapy during the study 18. Use of medications or treatments that may result in significant weight gain or loss within the previous 3 months 19. Received, or planned to undergo bariatric surgery or endoscopic and/or medical device-based bariatric therapy during the study, etc 20. Those who have a known or suspected allergy to the same or related products of the investigational drug and their excipients 21. Previous discontinuation of this class for safety/tolerability reasons 22. Participation in a clinical trial of any drug or medical device within 3 months prior to screening 23. Those who have donated or lost ≥ 400 mL of blood within the previous 3 months, or have received blood transfusions 24. Surgery is planned for the duration of the trial 25. Subjects who are mentally incapacitated or have language impairment who are unable to fully understand or participate in the trial process 26. Investigators and relevant staff of the research center or other persons directly involved in the implementation of the program, and their immediate family members; Employees of Hengrui Company; In the judgment of the investigator, there is any condition that affects the safety of the subject or any other interference with the evaluation of the test results

Primary outcome measure(s)

  • Percentage change from baseline in body weight after 52 weeks of treatment — 52 weeks

Trial sites (2)

FacilityCityRegionStatus
Chiness PLA General Hospital Beijing Beijing Municipality
Jiangsu Province Hospital Nanjing Jiangsu
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07285902 on ClinicalTrials.gov ↗ ← All trials in China