overweight and obese people
Conditions
Interventions
Group 1:DA-302168S Tablet/placebo
Group 2:DA-302168S Tablet/placebo
Group 3:DA-302168S Tablet/placebo
Group 4:DA-302168S Tablet/placebo
Sponsors
The Second Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1.Age 18~60 years old (including the threshold), male or female;2.Body weight: male = 50 kg, female = 45 kg, body mass index (BMI) within 24.0-35.0 kg/m2 (inclusive boundary value);3.Stable weight (self-reported weight change of less than 5%) in the 3 months prior to screening;4.The subject and his/her spouse or partner do not have a planned pregnancy or sperm donation between 14 days prior to screening and 3 months after the last dose,egg donation programme and agree to use at least one acceptable and effective method of contraception (see Appendix 2 for contraceptive methods);5.Subjects who are able to communicate well with the investigator, fully understand the purpose and requirements of the trial, volunteer to participate in the clinical trial and sign a written ICF.
Exclusion criteria
Exclusion criteria: 1.The presence of secondary obesity, such as that caused by metabolic disorders (e.g., Cushing's syndrome, decreased thyroid function, etc.) or pharmacological obesity (e.g., glucocorticoids, tricyclic antidepressants, atypical antipsychotics, etc.);2.Comorbidity with clinically significant cardiovascular disease, including, but not limited to, a history of angina pectoris, myocardial infarction, stroke, or severe peripheral arterial circulatory disturbances, or transient ischaemic attack within 1 year prior to signing up for an ICF; risk factors for tip-twisting ventricular tachycardia; untreated severe arrhythmia such as sinusitis, second- or third-degree atrioventricular block; and New York Heart Association Heart Failure in cardiac class II - IV (see Appendix 3); Translated with www.DeepL.com/Translator (free version);3.Previous or family history of medullary thyroid carcinoma, thyroid C-cell hyperplasia, or multiple endocrine adenomatosis type 2;4.Individuals who have had an episode of acute pancreatitis, an episode of acute cholecystitis within 3 months prior to signing the ICF, or who have previous chronic pancreatitis, a history of symptomatic gallbladder disease (e.g., multiple gallbladder stones, etc.), or a history of pancreatic injury, which may lead to high-risk factors for pancreatitis;5.Any malignancy (except cured basal cell carcinoma of the skin or carcinoma in situ of the cervix) within 5 years prior to signing the ICF;6.The presence of concomitant medical conditions, including but not limited to respiratory, gastrointestinal, neurological, genitourinary, haematological, and endocrine disorders, as determined by the Investigator, that may affect the safety of the subject or the determination of the results of the study;7.The presence of concomitant medical conditions, including but not limited to respiratory, gastrointestinal, neurological, genitourinary, haematological, and endocrine disorders, as determined by the Investigator, that may affect the safety of the subject or the determination of the results of the study;8.The presence of concomitant medical conditions, including but not limited to respiratory, gastrointestinal, neurological, genitourinary, haematological, and endocrine disorders, as determined by the Investigator, that may affect the safety of the subject or the determination of the results of the study;9.History of specific allergies (asthma, urticaria, eczema, etc.) or sensitivities, or hypersensitivity to any of the components of the test drug or preparation or to other GLP-1RA analogues or drugs with an agonist mechanism at the GLP-1 receptor;10.Those with HbA1c =6.5% at screening, or fasting blood glucose =7.0 mmol/L or =3.9 mmol/L, or with a previous diagnosis of type 1 diabetes, type 2 diabetes, or other specific type of diabetes (according to the criteria for diagnosis and classification of diabetes issued by the World Health Organisation [WHO] in 2019;11.History of abnormal thyroid function and continued need for medication at screening, or abnormal and clinically significant thyroid function results at screening;12.Past history of moderate to severe depression, anxiety disorders, or history of severe mental illness, e.g., schizophrenia, bipolar disorder, etc.; or past suicidal ideation or suicidal behaviour;13.Past history of moderate to severe depression, anxiety disorders, or history of severe mental illness, e.g., schizophrenia, bipolar disorder, etc.; or past suicidal ideation or suicidal
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability outcome; | — |
Secondary
| Measure | Time frame |
|---|---|
| PK outcome;PD outcome; | — |
Countries
China
Contacts
Public ContactHu wei
The Second Affiliated Hospital Of AnHui Medical University
Outcome results
None listed