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出境医 / 临床实验 / Effects of Benaglutide on Weight and Gut Microbiota in Obese Patients

Effects of Benaglutide on Weight and Gut Microbiota in Obese Patients

Study Description
Brief Summary:
The purpose of this studay is to evaluate the effects of Benaglutide on the treatment of subjects with obesity.

Condition or disease Intervention/treatment Phase
Obesity Drug: Benaglutide Drug: Liraglutide Phase 3

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Benaglutide on Weight and Gut Microbiota in Obese Patients
Actual Study Start Date : December 1, 2019
Estimated Primary Completion Date : December 23, 2021
Estimated Study Completion Date : December 23, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: Benaglutide
Benaglutide will be administered three times a day by subcutaneous injection (under the skin) in the abdomen, thigh, or upper arm. It will be given 10 minutes before each meal.
Drug: Benaglutide
The treatment of Benaglutide lasted three months.During the first week: 0.1mg per day;During the second week: 0.14mg per day; From third week onwards, 0.2mg per day.
Other Name: rhGLP-1(7-36)

Active Comparator: Liraglutide
Liraglutide will be administered once a day by subcutaneous injection (under the skin) in the abdomen, thigh, or upper arm. It will be given independently of meals and preferably at the same each day.
Drug: Liraglutide
The treatment of Liraglutide lasted three months.During the first week: 0.6mg per day;During the second week: 1.2mg per day; From third week onwards, 1.8mg per day.
Other Name: Victoza

Outcome Measures
Primary Outcome Measures :
  1. Weight Change at 3 months [ Time Frame: baseline and 3 months ]
    Measured in kilograms

  2. Gut microbiota composition [ Time Frame: 3 months ]
    Gut microbiota composition is assessed by 16S rRNA pyrosequencing. This analysis allows to obtain the relative abundance (%) of the different bacterial taxa and OTUs (operational taxonomic units).


Secondary Outcome Measures :
  1. Change in waist circumference [ Time Frame: baseline and 3 months ]
    Measured in cm

  2. Change in systolic blood pressure [ Time Frame: baseline and 3 months ]
    Measured in mmHg

  3. Change in diastolic blood pressure [ Time Frame: baseline and 3 months ]
    Measured in mmHg

  4. Change in HbA1c [ Time Frame: baseline and 3 months ]
    Measured in %

  5. Change in plasma glucose [ Time Frame: baseline and 3 months ]
    Measured in mmol/l

  6. Change in insulin [ Time Frame: baseline and 3 months ]
    Measured in μU/ml

  7. Change in lipids-total cholesterol [ Time Frame: baseline and 3 months ]
    Measured in mmol/l

  8. Change in lipids-low density lipoprotein cholesterol [ Time Frame: baseline and 3 months ]
    Measured in mmol/l

  9. Change in lipids-high density lipoprotein cholesterol [ Time Frame: baseline and 3 months ]
    Measured in mmol/l

  10. Change in lipids-triglycerides [ Time Frame: baseline and 3 months ]
    Measured in mmol/l

  11. Change in lipids-free fatty acids [ Time Frame: baseline and 3 months ]
    Measured in μmol/l

  12. Change in Uric Acid [ Time Frame: baseline and 3 months ]
    Measured in mmol/l

  13. Change in interleukin-10 [ Time Frame: baseline and 3 months ]
    Measured in mmol/l

  14. Change in tumor necrosis factor [ Time Frame: baseline and 3 months ]
    Measured in mmol/l


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients aged 18 to 65 years (to the date of screening);
  2. The newly diagnosed obese patients (BMI greater than 28 kg/m2) or abdominal obesity (male waist circumference is greater than 90cm, female waist is greater than 85cm).
  3. Nearly a month have not used weight-related drugs,including various weight-loss drugs,GLP-1 analogs or agonists,metformin, acarbose,insulin,anti hyperthyroid drugs,etc;Or recently used weight-related drugs but the stable dose was more than 1 month,and the drug dose remained constant or decreased during the trial.
  4. Weight stable for more than 3 months (weight fluctuations <5%).

Exclusion Criteria:

  1. pregnant female.
  2. Secondary diseases caused by other diseases: including hypothyroidism, increased cortisol, hypothalamic and pituitary lesions caused by obesity, all kinds of drug-induced obesity, and others.
  3. Severe cardiovascular and cerebrovascular diseases (heart failure, myocardial infarction, acute hemorrhagic or ischemic encephalopathy), pulmonary heart disease or pulmonary insufficiency, renal failure, severe hepatitis.
  4. Combined with acute complications of diabetes such as ketoacidosis, lactic acidosis, hyperosmolar state of diabetes.
  5. Nearly a month had surgery, trauma, infection and so on.
  6. Limb deformity incomplete, difficult to accurately determine the height, weight and other physical indicators.
  7. Poor medication compliance or serious side effects (severe rash, syncope, etc.).
Contacts and Locations

Contacts
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Contact: Jing Wu +8613574120508 wujing0731@163.com

Locations
Layout table for location information
China, Hunan
Xiangya Hospital of Central South University Recruiting
Changsha, Hunan, China, 410008
Contact: Jing Wu    +86-13574120508    wujing0731@163.com   
Sponsors and Collaborators
Xiangya Hospital of Central South University
Investigators
Layout table for investigator information
Principal Investigator: Jing Wu Xiangya Hospital of Central South University
Tracking Information
First Submitted Date  ICMJE June 11, 2019
First Posted Date  ICMJE June 14, 2019
Last Update Posted Date April 9, 2021
Actual Study Start Date  ICMJE December 1, 2019
Estimated Primary Completion Date December 23, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 11, 2019)
  • Weight Change at 3 months [ Time Frame: baseline and 3 months ]
    Measured in kilograms
  • Gut microbiota composition [ Time Frame: 3 months ]
    Gut microbiota composition is assessed by 16S rRNA pyrosequencing. This analysis allows to obtain the relative abundance (%) of the different bacterial taxa and OTUs (operational taxonomic units).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2019)
  • Change in waist circumference [ Time Frame: baseline and 3 months ]
    Measured in cm
  • Change in systolic blood pressure [ Time Frame: baseline and 3 months ]
    Measured in mmHg
  • Change in diastolic blood pressure [ Time Frame: baseline and 3 months ]
    Measured in mmHg
  • Change in HbA1c [ Time Frame: baseline and 3 months ]
    Measured in %
  • Change in plasma glucose [ Time Frame: baseline and 3 months ]
    Measured in mmol/l
  • Change in insulin [ Time Frame: baseline and 3 months ]
    Measured in μU/ml
  • Change in lipids-total cholesterol [ Time Frame: baseline and 3 months ]
    Measured in mmol/l
  • Change in lipids-low density lipoprotein cholesterol [ Time Frame: baseline and 3 months ]
    Measured in mmol/l
  • Change in lipids-high density lipoprotein cholesterol [ Time Frame: baseline and 3 months ]
    Measured in mmol/l
  • Change in lipids-triglycerides [ Time Frame: baseline and 3 months ]
    Measured in mmol/l
  • Change in lipids-free fatty acids [ Time Frame: baseline and 3 months ]
    Measured in μmol/l
  • Change in Uric Acid [ Time Frame: baseline and 3 months ]
    Measured in mmol/l
  • Change in interleukin-10 [ Time Frame: baseline and 3 months ]
    Measured in mmol/l
  • Change in tumor necrosis factor [ Time Frame: baseline and 3 months ]
    Measured in mmol/l
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Benaglutide on Weight and Gut Microbiota in Obese Patients
Official Title  ICMJE Effects of Benaglutide on Weight and Gut Microbiota in Obese Patients
Brief Summary The purpose of this studay is to evaluate the effects of Benaglutide on the treatment of subjects with obesity.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Obesity
Intervention  ICMJE
  • Drug: Benaglutide
    The treatment of Benaglutide lasted three months.During the first week: 0.1mg per day;During the second week: 0.14mg per day; From third week onwards, 0.2mg per day.
    Other Name: rhGLP-1(7-36)
  • Drug: Liraglutide
    The treatment of Liraglutide lasted three months.During the first week: 0.6mg per day;During the second week: 1.2mg per day; From third week onwards, 1.8mg per day.
    Other Name: Victoza
Study Arms  ICMJE
  • Experimental: Benaglutide
    Benaglutide will be administered three times a day by subcutaneous injection (under the skin) in the abdomen, thigh, or upper arm. It will be given 10 minutes before each meal.
    Intervention: Drug: Benaglutide
  • Active Comparator: Liraglutide
    Liraglutide will be administered once a day by subcutaneous injection (under the skin) in the abdomen, thigh, or upper arm. It will be given independently of meals and preferably at the same each day.
    Intervention: Drug: Liraglutide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 11, 2019)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 23, 2021
Estimated Primary Completion Date December 23, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patients aged 18 to 65 years (to the date of screening);
  2. The newly diagnosed obese patients (BMI greater than 28 kg/m2) or abdominal obesity (male waist circumference is greater than 90cm, female waist is greater than 85cm).
  3. Nearly a month have not used weight-related drugs,including various weight-loss drugs,GLP-1 analogs or agonists,metformin, acarbose,insulin,anti hyperthyroid drugs,etc;Or recently used weight-related drugs but the stable dose was more than 1 month,and the drug dose remained constant or decreased during the trial.
  4. Weight stable for more than 3 months (weight fluctuations <5%).

Exclusion Criteria:

  1. pregnant female.
  2. Secondary diseases caused by other diseases: including hypothyroidism, increased cortisol, hypothalamic and pituitary lesions caused by obesity, all kinds of drug-induced obesity, and others.
  3. Severe cardiovascular and cerebrovascular diseases (heart failure, myocardial infarction, acute hemorrhagic or ischemic encephalopathy), pulmonary heart disease or pulmonary insufficiency, renal failure, severe hepatitis.
  4. Combined with acute complications of diabetes such as ketoacidosis, lactic acidosis, hyperosmolar state of diabetes.
  5. Nearly a month had surgery, trauma, infection and so on.
  6. Limb deformity incomplete, difficult to accurately determine the height, weight and other physical indicators.
  7. Poor medication compliance or serious side effects (severe rash, syncope, etc.).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jing Wu +8613574120508 wujing0731@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03986008
Other Study ID Numbers  ICMJE 2019050125
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Xiangya Hospital of Central South University
Study Sponsor  ICMJE Xiangya Hospital of Central South University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jing Wu Xiangya Hospital of Central South University
PRS Account Xiangya Hospital of Central South University
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP