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

Fujian Shengdi Pharmaceutical

Status and phase: Enrolling; Phase 3

Conditions: Obesity

Treatments: Drug: Semaglutide Injection; Drug: HRS9531 injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT07285902

HRS9531-308

Details and patient eligibility

About

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

Enrollment: 750 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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750 participants in 2 patient groups

Treatment group A: HRS9531 injection

Experimental group

Treatment:

Drug: HRS9531 injection

Treatment group B: Semaglutide Injection

Active Comparator group

Treatment:

Drug: Semaglutide Injection