Pharmacokinetics of Benaglutide Injection in Overweight/Obese Adults

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.

Study Overview

• Status: Completed
• Conditions: Overweight/Obese Adults
• Intervention / Treatment: Drug: Benaglutide Injection

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shandong
    • Qingdao, Shandong, China, 266003
      • The Affiliated Hospital of Qingdao University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Benaglutide Injection; 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.	Drug: Benaglutide Injection; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the plasma concentration versus time curve (AUC)0-t	Evaluation of Area under the plasma concentration versus time curve (AUC)0-t	80 days
Peak Plasma Concentration (Cmax)	Evaluation of Peak Plasma Concentration (Cmax)	80 days
Area under the plasma concentration versus time curve (AUC)0-∞	Evaluation of Area under the plasma concentration versus time curve (AUC)0-∞	80 days
elimination half-life time(T1/2)	Evaluation of elimination half-life time(T1/2)	80 days
The total clearance(CL)	Evaluation of the total clearance(CL)	80 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment Adverse Events	Collection of adverse events	80 days

Collaborators and Investigators

• Sponsor: The Affiliated Hospital of Qingdao University

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2020
• Primary Completion (Actual): December 1, 2020
• Study Completion (Actual): May 20, 2021

Study Registration Dates

• First Submitted: January 28, 2022
• First Submitted That Met QC Criteria: January 28, 2022
• First Posted (Actual): February 7, 2022

Study Record Updates

• Last Update Posted (Actual): February 7, 2022
• Last Update Submitted That Met QC Criteria: January 28, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: RH-RCT-IS-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No