Efficacy and Safety of HDM1005 in Chinese Obesity or Overweight Patients Without Diabetes

Prior treatment

• Use of GLP-1 receptor (GLP-1R) agonists or GLP-1R/GCGR agonists or GIPR/GLP-1R agonists or GIPR/GLP-1R/GCGR agonists within 3 months prior to screening.
• Use of hypoglycemic drugs within 3 months prior to screening.
• Previous history of acute and chronic pancreatitis, acute gallbladder disease history (except cholecystectomy) history.
• Uncontrolled hypertension prior to screening, defined as: systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg (stable for 1 month if using antihypertensive drugs).

Other illness

• Have type 1 diabetes mellitus (T1DM) or T2DM.
• Have obesity induced by other endocrinologic disorders (for example, Cushing syndrome) or by other medicine.
• History of thyroid C-cell carcinoma, multiple endocrine neoplasia (MEN) 2A or 2B or relevant family history.
• Have had a history of moderate to severe depression; Or have a history of severe mental illness in the past.
• History of malignancy (except cured basal cell carcinoma) in the past 5 years or at the time of screening.
• History of severe cardiovascular or cerebrovascular diseases within the past six months.
• History of alcohol and drug abuse at screening.
• The participant may be allergic to ingredients in the study drug or drugs of the same class.

Lab values

• Have HbA1c≥6.5% or fasting serum glucose (FSG)≥7.0 mmol/L at Visit 1.

Other

• PHQ questionnaire ≥ 15 points at screening or randomization.
• Pregnant or lactating females, males or females of childbearing potential not willing to use contraception throughout the study.
• The subject has any other factors that may affect the efficacy or safety evaluation of this study, and is not suitable for participation in this study in the opinion of the investigator.

• Male or female, aged ≥18 years at the time of signing informed consent.
• BMI≥28 kg/m2 or ≥24 kg/m2 and previously diagnosed with at least one of the following weight related comorbidities: hypertension, dyslipidemia, pre-diabetes, obstructive sleep apnea, fatty liver, weight-bearing joint pain.
• A self-reported change in body weight no more than 5% within 90 days before screening.
• Able to understand the procedures and methods of this study, willing to strictly comply with the clinical trial protocol to complete this trial, and voluntarily sign the informed consent form.