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

Korábbi kezelés

• Previous or known history of acute or chronic pancreatitis, pancreatic injury; Patients with a history of acute cholecystitis or symptomatic/treatment-inducing gallbladder disease
• Previous or known history or family history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia type 2 (MEN2).
• Severe infection, severe trauma, or large and medium-sized surgery within 1 month prior to screening
• History of severe cardiovascular and cerebrovascular diseases within the previous 6 months
• Use of medications or treatments that may result in significant weight gain or loss within the previous 3 months
• Received, or planned to undergo bariatric surgery or endoscopic and/or medical device-based bariatric therapy during the study, etc
• Those who have a known or suspected allergy to the same or related products of the investigational drug and their excipients
• Previous discontinuation of this class for safety/tolerability reasons
• Participation in a clinical trial of any drug or medical device within 3 months prior to screening
• Those who have donated or lost ≥ 400 mL of blood within the previous 3 months, or have received blood transfusions
• Surgery is planned for the duration of the trial

Más betegség

• Presence or history of endocrine disorders that may significantly affect body weight
• History of diabetes mellitus
• Those who have had any previous disease or history that affects gastric emptying, or who have undergone gastrointestinal surgery
• Malignancy of any organ system within 5 years
• Presence or suspicion of depression, bipolar disorder, suicidal tendencies, People with schizophrenia or other more serious mental illness
• Known or suspected history of alcohol and/or drug abuse or drug abuse
• Presence of a history of acute or chronic hepatitis or other serious liver disease other than non-alcoholic fatty liver disease
• Presence of autoimmune disease with planned use of systemic glucocorticoids or immunosuppressive therapy during the study
• Subjects who are mentally incapacitated or have language impairment who are unable to fully understand or participate in the trial process
• 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

Laborértékek

• Presence of any hematologic disorder that may interfere with HbA1c detection

Egyéb

• Those with abnormal relevant examinations at screening;
• ECG results are abnormal and may affect the safety of the subject
• Poor blood pressure control
• The PHQ-9 score ≥ 15 points

• 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;
• Age ≥ 18 years old on the day of signing the informed consent, regardless of gender;
• obesity
• Self-reported diet and exercise control for 3 months or more before screening, and weight change of ≤ 5 kg in the past 3 months.
• 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.