Status:
COMPLETED
Pharmacokinetics of Benaglutide Injection in Overweight/Obese Adults
Lead Sponsor:
The Affiliated Hospital of Qingdao University
Conditions:
Overweight/Obese Adults
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
This study is a open and multiple dose escalation phase I clinical study, aiming to evaluate the pharmacokinetic characteristics and safety of Benaglutide Injection in overweight/obese adults after mu...
Eligibility Criteria
Inclusion
- Male or female aged between 18 and 70 years old (including the critical value).
- BMI meets the following requirements (a or b):
- BMI\>28 kg/m2;
- 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
- 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
Key Trial Info
Start Date :
July 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 20 2021
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT05226000
Start Date
July 7 2020
End Date
May 20 2021
Last Update
February 7 2022
Active Locations (1)
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1
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China, 266003