Pharmacokinetics of Benaglutide Injection in Overweight/Obese Adults

Inclusion Criteria:

• Male or female aged between 18 and 70 years old (including the critical value).

• BMI meets the following requirements (a or b):

  1. BMI>28 kg/m2;
  2. BMI>24 kg/m2 with at least one of the following symptoms:

Vigorous appetite, hunger before meals unbearable, each meal into more food. Combined with hyperglycemia, hypertension, dyslipidemia, fatty liver in one or several.

Combined with weight-bearing joint pain. Obesity causes dyspnea or obstructive sleep apnea syndrome.

• The following examination show that the indicators are normal or abnormal without clinical significance. The examination including: Vital signs, physical examination, blood routine, blood biochemistry, urinalysis, pregnancy test for female, serological tests for hepatitis B virus, hepatitis C virus, human immunodeficiency virus (HIV), and syphilis virus, 12 lead ECG.
• The subjects have no family planning within 3 months and could select contraceptive method.
• Before the study, all subjects have been informed of the study's purpose, protocal, benefits, and risks, and signed the informed consent voluntarily.

Exclusion Criteria:

• Patients with type 1 diabetes or type 2 diabetes with a clear diagnosis;
• Fasting intravenous blood glucose ≥7 mmol/L or 75g during screening. Oral glucose tolerance test (OGTT) two hours after glucose load;
• Fasting venous blood glucose <2.8 mmol/L at screening, and/or those with a history of hypoglycemia;
• Those who complained of a weight change of >5% within 3 months before screening;
• Have used weight loss drugs or hypoglycemic drugs that may affect body weight within 4 weeks before screening;
• Drugs used within 4 weeks before screening that may cause significant weight gain: including systemic glucocorticoid therapy (lasting more than 1 week); tricyclic antidepressants; antipsychotic or antidepressant drugs; may interfere with blood sugar regulation Functional medicine; all proprietary Chinese medicines and Chinese herbal medicines;
• Those who have a clear history of malignant tumors,
• People with Cushing's syndrome, hypothyroidism, polycystic ovary disease or other genetic endocrine diseases or medical history;
• Those who have a history of bariatric surgery;
• Have a history of multiple endocrine tumors or a family history; have a history of medullary thyroid carcinoma or other tumors, a family history;
• History of acute and chronic pancreatitis;
• Moderate to severe gastrointestinal diseases with additional gastrointestinal motility disorders or obstructive enteropathy;
• Have a clear history of mental illness