HDM1002 Tablets in Chinese Overweight and Obese Adult Subjects

Exclusion Criteria

• •Selection criteria:
• •Subjects meeting either of the following criteria will be excluded:
• •1. 5% self-reported or documented body weight change within 3 months prior to randomization;
• •2. Previous diagnosis of type 1, type 2 or any other type of diabetes; or using hypoglycemic drugs; or HbA1c 6.5% at screening or fasting glucose 7.0 mmol/L; or fasting glucose \<3.9 mmol / L;
• •3. Diagnosis of overweight or obesity caused by other diseases or drugs;
• •4. History or family history of medullary thyroid carcinoma, thyroid C cell hyperplasia, or multiple endocrine adenomatosis type 2;
• •5. History of chronic pancreatitis or onset of acute pancreatitis within 3 months before signing an ICF;
• •6. History of acute gallbladder disease within 3 months before signing the ICF;
• •7. Any malignant tumor within 5 years before signing the ICF (except for basal cell carcinoma that has received curative treatment and is considered cured);
• •8. Combination of cardiovascular and cerebrovascular diseases with obvious clinical significance, including but not limited to angina pectoris, MI, stroke or severe peripheral artery circulation disorder within 1 year before signing ICF; presence of risk factors of torsade ventricular tachycardia; presence of untreated serious arrhythmia, such as sick sinus syndrome, second or third degree atrioventricular block; or screening systolic blood pressure 160 mmHg, or diastolic blood pressure 100 mmHg;
• •9. In the judgment of the investigator, the subjects had some diseases or conditions that may affect drug absorption, such as active inflammatory bowel disease, gastrectomy resection, any intestinal area resection, etc.;
• •10. Those who had major surgery within 3 months prior to signing the ICF or who performed surgery during the planned study;
• •11. According to the investigator, the presence of concomitant diseases, including but not limited to the respiratory system, digestive system, nervous system, urogenital system, blood system, endocrine system and other diseases;
• •12. Known intolerance or hypersensitivity to a GLP-1 receptor (GLP-1R) agonist;
• •13. Within 3 months prior to ICF signing, the following drugs were used and significantly weight, including but not limited to: a. Drugs or products with weight loss effects, such as GLP-1R agonists (liraglutide, selmeaglutide, benallutide, etc.), orlistat, naltrexone / bupropion, etc.; b. Drugs or products that increase body weight, such as systemic corticosteroids, psychiatric medication (e. g., tricyclic antidepressants, paroxetine, olanzapine, clozapine, mirtazapine, valproic acid and its derivatives, etc.); c. Any Chinese patent medicine or Chinese herbal medicine that may affect the body weight;
• •14. Any drug used within 14 days or may affect the pharmacokinetics of HDM1002 tablets (whichever is older) (see Section 6.4.2 and Section 6.4.3), including prescription drugs, over-the-counter drugs, Chinese herbal medicines, proprietary Chinese medicines, or nutritional supplements;
• •15. Subjects taking lipid-lowering drugs within 30 days before signing ICF;
• •16. Have participated in any clinical trial within 30 days before randomization or within 5 half-lives after the last dose (whichever is older) (except for signed ICF with no drug or device intervention);
• •17. Any of the laboratory indicators during the screening period met the following criteria:
• •1. \<110 g / L for women and \<120 g / L for men;
• •2. glutamate aminotransferase\> 2.0 upper limit of normal (ULN), or aminotransferase\> 2.0 ULN, or alkaline phosphatase\> 1.5 x ULN, or total bilirubin\> 1.5 ULN (subjects with Gil bert's syndrome can participate in this study with direct bilirubin ULN);
• •3. Triglycerides\> 5.6 mmol / L;
• •4. Calcitonin: 35 ng/L;
• •5. Thyroid-stimulating hormone\> 6.0 mIU / L or \<0.4 mIU / L;
• •6. Blood amylase or lipase\> ULN;
• •7. Estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73m, calculated from the Cooperative Epidemiological Study of Chronic Kidney Disease (CKD-EPI) formula2；
• •18. The following ECG abnormalities were present during the screening period: QTcF\> 450 ms, or heart rate \<50 beats / min or\> 100 beats / min;
• •19. Positive test results for hepatitis B virus surface antigen, hepatitis C virus antibody or treponema pallidum antibody, or non-negative for human immunodeficiency virus;
• •20. More than 5 cigarettes per day in the 3 months before signing the ICF;
• •21. Those who had drunk alcohol abuse within 1 year before signing the ICF (i. e., drinking more than 14 standard units per week for men, women drinking more than 7 standard units per week, 1 standard unit containing 14 g alcohol, such as 360 ml beer or 150 ml alcohol of 40 ml), or prerandomized alcohol breath test or blood alcohol test positive;
• •22. History of addictive drug abuse within 1 year before signing the ICF, or positive urine drug test before randomization;
• •23. Within 7 days prior to randomization, subjects reported having consumed grapefruit or products containing grapefruit;
• •24. Pregnancy (blood human chorionic gonadotropin 5 mIU / ml or positive urine pregnancy test) or lactating women;
• •25. The subject is the investigator or other relevant investigator of the project;
• •26. In the opinion of the investigator, the subject was not fit to participate in any other condition of the trial.