| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| 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 |
|---|---|
|
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 | |||||
|---|---|---|---|---|---|
| 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 | ||||
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* 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 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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