Condition or disease | Intervention/treatment | Phase |
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Obesity | Drug: Benaglutide Drug: Liraglutide | Phase 3 |
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 |
Arm | Intervention/treatment |
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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.
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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)
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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.
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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
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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 |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jing Wu | +8613574120508 | wujing0731@163.com |
China, Hunan | |
Xiangya Hospital of Central South University | Recruiting |
Changsha, Hunan, China, 410008 | |
Contact: Jing Wu +86-13574120508 wujing0731@163.com |
Principal Investigator: | Jing Wu | Xiangya Hospital of Central South University |
Tracking Information | |||||
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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 |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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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 |
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Condition ICMJE | Obesity | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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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 |
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IPD Sharing Statement ICMJE |
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Responsible Party | Xiangya Hospital of Central South University | ||||
Study Sponsor ICMJE | Xiangya Hospital of Central South University | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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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 |