overweight/obesity
Conditions
Interventions
Continuous subcutaneous beinaglutide infusion(Step 1):Beinaglutide delivered via an insulin pump as a continuous subcutaneous infusion with basal doses
Continuous subcutaneous beinaglutide infusion(Step 2):Beinaglutide delivered via an insulin pump as a continuous subcutaneous infusion with basal dose + premeal doses(using a square-wave bolus)
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Adult male or female aged between 18 and 65 years (inclusive, subject to signing of informed consent form); 2. Body mass index (BMI) 24-35 kg/m2 (inclusive); 3. Undergone physical examination, complete blood count, urine test, blood biochemistry, 12 lead electrocardiogram and other tests during screening and have been determined to have no abnormalities/no clinical significance by the researchers; 4. The subject does not have plans for pregnancy and voluntarily apply effective contraceptive measures within 90 days after the last dose of drug, and does not have plans to donate sperm or eggs; 5. The subject fully understands the purpose/nature/method, and potential adverse reactions of the trial, voluntarily acts as subjects, and sign an informed consent form; 6. Be able to complete the trial according to the requirements of the protocol.
Exclusion criteria
Exclusion criteria: 1. Type 1 diabetes or type 2 diabetes patients with definite diagnosis; 2. Fasting blood glucose = 7 mmol/L or 2h oral glucose tolerance test (OGTT) = 11.1 mmol/L at screening; 3. Fasting blood glucose 5% within 3 months before screening; 5. Treatment with weight loss drugs or diabetes drugs that may affect weight within 4 weeks before screening; 6. Treatment with drugs that may cause significant weight gain within 4 weeks before screening, including systemic glucocorticoid therapy (for more than 1 week); tricyclic antidepressants; antipsychotic or antidepressant drugs; drugs that may interfere with blood sugar regulation function; 7. Treatment with any traditional Chinese medicine or herbal medicine within 14 days before the start of the trial; 8. Clear or suspected history of malignant tumors, including: - Researchers cannot determine or rule out a history of malignant "tumors", such as "XX masses", "XX nodules", "XX masses", etc; - Lack of pathological reports/conclusions confirming the benign and malignant nature of thyroid nodules, or TI-RADS = 3 categories (excluding the history of thyroid nodules without relevant pathological reports and TI-RADS = 2 categories); 9. History of Cushing's syndrome, hypothyroidism, polycystic ovary disease, or other genetic endocrine diseases; 10. History of weight loss surgery; 11. History or family history of type 2 multiple endocrine neoplasia (MEN-2) or medullary thyroid carcinoma (MTC); 12. History of acute and chronic pancreatitis; 13. Moderate to severe gastrointestinal diseases with gastrointestinal motility disorders or obstructive bowel diseases; 14. History of mental illness, such as schizophrenia, bipolar disorder, or a PHQ-9 questionnaire with a score of = 15 at screening; 15. Recent history of cardiovascular disease (myocardial infarction or stroke within the past 6 months), severe congestive heart failure (NYHA III, IV), or second degree or more severe heart conduction block; other preexisting cardiovascular system diseases, which the researchers believe may pose risks or interfere with the interpretation of the data; 16. Systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg; 17. Active liver disease, or liver function such as alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin > 1.5 times upper limit of normal (ULN) at screening; 18. Blood amylase and/or lipase levels > 1.2 times ULN; 19. Renal function (serum creatinine level) > 1.2 times ULN; 20. Severe lipid metabolism disorder, with low density lipoprotein (LDL) = 4.40mmol/L or triglycerides (TG) = 5.65mmol/L; 21. Positive infection screening results (hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), AIDS virus antibody (Anti-HIV), treponema pallidum antibody (TP-Ab)); 22. Participation in any clinical trials involving drugs or medical devices within 90 days before screening; 23. Undergone elective hospitalization or surgery within 30 days before screening; 24. History of drug use/abuse or positive urine drug screening results; 25. History of alcohol consumption exceeding 14 units per week (1 unit = 360 mL of beer [5% vol] or 45 mL of spirits [40% vol] or 150 mL of wine [12% vol]) within the 180 days before screening, or those who are unable to abstain from alcohol from 48 hours before enrollment until discharge; 26. Smoke more than 5 cigarettes per day or habitually use nico
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters of continuous subcutaneous beinaglutide infusion ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety profiles of continuous subcutaneous beinaglutide infusion ; | — |
Countries
China
Contacts
Public ContactFang Yì
Peking University People's Hospital
Outcome results
None listed