Obesity
Conditions
Brief 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
Interventions
HRS9531 injection
Semaglutide Injection
Sponsors
Fujian Shengdi Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage change from baseline in body weight after 52 weeks of treatment | 52 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects with target reduction from baseline in body weight after 52 weeks of treatment | 52 weeks |
| Change from baseline in waist circumference,after 52 weeks of treatment | 52 weeks |
| Change from baseline in body weight after 52 weeks of treatment | 52 weeks |
| Change from baseline in body mass index (BMI) after 52 weeks of treatmentChange from baseline in blood pressure,after 52 weeks of treatment | 52 weeks |
| Change from baseline in fasting plasma glucose (FPG)after 52 weeks of treatment | 52 weeks |
| Change from baseline in glycosylated haemoglobin (HbA1c) after 52 weeks of treatment | 52 weeks |
| Change from baseline in liver enzymes after 52 weeks of treatment | 52 weeks |
| Change from baseline in fasting serum insulin after 52 weeks of treatment | 52 weeks |
| Change from baseline in lipid parameters after 52 weeks of treatment | 52 weeks |
| Number of AEs during the trial. | 52 weeks |
Countries
China
Outcome results
None listed