search
Back to results

Pharmacokinetics of Benaglutide Injection in Overweight/Obese Adults

Primary Purpose

Overweight/Obese Adults

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Benaglutide Injection
Sponsored by
The Affiliated Hospital of Qingdao University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight/Obese Adults

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Affiliated Hospital of Qingdao University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Benaglutide Injection

Arm Description

All subjects received multiple doses (tid) of 0.06 mg, 0.1 mg, 0.14 mg, and 0.2 mg in sequence, followed by the next dose after completing the previous multiple dosing. The administration time of each dose was 0.06 mg for 3 days, 0.1 mg for 3 days, 0.14 mg for 5 days, and 0.2 mg for 5 days.

Outcomes

Primary Outcome Measures

Peak Plasma Concentration (Cmax)
Evaluation of Peak Plasma Concentration (Cmax)
Area under the plasma concentration versus time curve (AUC)0-t
Evaluation of Area under the plasma concentration versus time curve (AUC)0-t
Area under the plasma concentration versus time curve (AUC)0-∞
Evaluation of Area under the plasma concentration versus time curve (AUC)0-∞
elimination half-life time(T1/2)
Evaluation of elimination half-life time(T1/2)
The total clearance(CL)
Evaluation of the total clearance(CL)

Secondary Outcome Measures

Incidence of Treatment Adverse Events
Collection of adverse events

Full Information

First Posted
January 28, 2022
Last Updated
January 28, 2022
Sponsor
The Affiliated Hospital of Qingdao University
search

1. Study Identification

Unique Protocol Identification Number
NCT05226000
Brief Title
Pharmacokinetics of Benaglutide Injection in Overweight/Obese Adults
Official Title
Pharmacokinetics of Benaglutide Injection in Overweight/Obese Adults
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
July 7, 2020 (Actual)
Primary Completion Date
December 1, 2020 (Actual)
Study Completion Date
May 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Affiliated Hospital of Qingdao University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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 multiple subcutaneous injections. This study will enroll 16 overweight/obese adults, both male and female. The trial was divided into two batches, including 4 subjects who completed all dosing, safety assessment and telephone follow-up, and the remaining 12 subjects who were enrolled for the trial. All subjects received multiple doses (tid) of 0.06 mg, 0.1 mg, 0.14 mg, and 0.2 mg in sequence, followed by the next dose after completing the previous multiple dosing. The administration time of each dose was 0.06 mg for 3 days, 0.1 mg for 3 days, 0.14 mg for 5 days, and 0.2 mg for 5 days. Subjects will be screened at D-14-D-2, and eligible subjects D-2 will be admitted to the phase I clinical trial ward at D-2. D-1 Blank blood samples were collected at different time points before and after breakfast for PK test baseline correction. D1 began by subcutaneously injecting different doses of benaglutide injection 5 minutes before the daily three meals, collecting biological samples at different time points after the first administration of D6, D7, D11, D12 and D16 to evaluate the pharmacokinetic characteristics of Benaglutide. Subjects will be discharged after all samples are collected and safety assessed at D17. Telephone follow-up was performed on the 7th day after discharge (D24±2) to further observe safety.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight/Obese Adults

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Benaglutide Injection
Arm Type
Experimental
Arm Description
All subjects received multiple doses (tid) of 0.06 mg, 0.1 mg, 0.14 mg, and 0.2 mg in sequence, followed by the next dose after completing the previous multiple dosing. The administration time of each dose was 0.06 mg for 3 days, 0.1 mg for 3 days, 0.14 mg for 5 days, and 0.2 mg for 5 days.
Intervention Type
Drug
Intervention Name(s)
Benaglutide Injection
Intervention Description
All subjects received multiple doses (tid) of 0.06 mg, 0.1 mg, 0.14 mg, and 0.2 mg in sequence, followed by the next dose after completing the previous multiple dosing. The administration time of each dose was 0.06 mg for 3 days, 0.1 mg for 3 days, 0.14 mg for 5 days, and 0.2 mg for 5 days.
Primary Outcome Measure Information:
Title
Peak Plasma Concentration (Cmax)
Description
Evaluation of Peak Plasma Concentration (Cmax)
Time Frame
80 days
Title
Area under the plasma concentration versus time curve (AUC)0-t
Description
Evaluation of Area under the plasma concentration versus time curve (AUC)0-t
Time Frame
80 days
Title
Area under the plasma concentration versus time curve (AUC)0-∞
Description
Evaluation of Area under the plasma concentration versus time curve (AUC)0-∞
Time Frame
80 days
Title
elimination half-life time(T1/2)
Description
Evaluation of elimination half-life time(T1/2)
Time Frame
80 days
Title
The total clearance(CL)
Description
Evaluation of the total clearance(CL)
Time Frame
80 days
Secondary Outcome Measure Information:
Title
Incidence of Treatment Adverse Events
Description
Collection of adverse events
Time Frame
80 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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
Facility Information:
Facility Name
The Affiliated Hospital of Qingdao University
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266003
Country
China

12. IPD Sharing Statement

Learn more about this trial

Pharmacokinetics of Benaglutide Injection in Overweight/Obese Adults

We'll reach out to this number within 24 hrs