Phase Ib Clinical Study of HDM1005 Injection

Exclusion Criteria

• •Subjects who meet any of the following criteria will be excluded:
• •Within 3 months before screening, subjects' body weight changed by ≥5%
• •Previously diagnosed with type 1, type 2, or another type of diabetes
• •Diagnosis of overweight or obesity due to other diseases or medications
• •History or family history of medullary thyroid carcinoma, thyroid C-cell hyperplasia, or multiple endocrine adenomatosis type 2
• •As determined by the investigator, the subjects have co-existing diseases or conditions that affect gastric emptying or gastrointestinal nutrient absorption.
• •Cardiovascular and cerebrovascular diseases, gastrointestinal diseases, diabetes mellitus, medullary thyroid cancer, thyroid C cell hyperplasia, multiple endocrine adenomatosis type 2, chronic pancreatitis, and malignant tumors with obvious clinical significance were present; And any respiratory, neurological, urogenital, hematological, or endocrine disorders that may affect the safety of the subject or the findings of the study
• •Any malignancy within 5 years prior to signing the ICF (except for basal cell carcinoma that has received curative treatment and is considered cured)
• •Patients who have undergone major surgery within 3 months before signing the ICF, or who plan to undergo surgery during the study period
• •Previous or combined depression or other mental disorders
• •Known intolerance or allergy to any component of the investigational drug or GLP-1 receptor (GLP-1R) agonists; Or have a history of severe drug allergies
• •Use of GLP-1R agonists within 6 months before signing the ICF
• •Drugs that have been used within 3 months before signing ICF and have been determined by researchers to significantly affect weight and glucose
• •For subjects taking lipid-lowering drugs, the dose of lipid-lowering drugs was not stable within 30 days before signing the ICF
• •Participated in any clinical trial within 30 days prior to randomization or within 5 half-lives (whichever is older) after the last administration of the investigational drug in the clinical trial (except those who signed ICF and did not receive drug or device intervention)
• •Any of the auxiliary test indicators during the screening period meets the following criteria:
• •a) Hemoglobin \<100g/L for women and \< 110g/L for men; b) ALT\>2.0x upper limit of normal (ULN), or AST\>2.0x ULN, or ALP\>1.5x ULN, or TBIL\>1.5x ULN (Subjects with Gilbert's syndrome can participate in this study if DBIL≤ULN); c) HbA1c≥6.5%, or fasting blood glucose ≥7.0 mmol/L or ≤3.9 mmol/L; d) Triglyceride \>5.6 mmol/L; e) calcitonin ≥20 ng/L; f) Thyroid stimulating hormone \>6.0 mIU/L or \<0.4 mIU/L g) blood amylase or lipase \>ULN; h)eGFR \< 90 mL/min/1.73m2; i) QTcF Male \>450ms, female \>470ms
• •People tested positive for infectious diseases
• •Habitual smokers, alcoholics and drug abusers
• •Blood donors within 3 months prior to randomization
• •Pregnant or lactating women
• •The Investigator considers that the subject is not suitable to participate in any other circumstances of the trial