Effects of Benaglutide on Weight and Gut Microbiota in Obese Patients

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

Official Title
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Effects of Benaglutide on Weight and Gut Microbiota in Obese Patients

Conditions
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Obesity

Intervention / Treatment
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* Drug: Benaglutide
* Drug: Liraglutide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 18 to 65 years (to the date of screening)； 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). 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. Weight stable for more than 3 months (weight fluctuations <5%). Exclusion Criteria: pregnant female. 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. Severe cardiovascular and cerebrovascular diseases (heart failure, myocardial infarction, acute hemorrhagic or ischemic encephalopathy), pulmonary heart disease or pulmonary insufficiency, renal failure, severe hepatitis. Combined with acute complications of diabetes such as ketoacidosis, lactic acidosis, hyperosmolar state of diabetes. Nearly a month had surgery, trauma, infection and so on. Limb deformity incomplete, difficult to accurately determine the height, weight and other physical indicators. Poor medication compliance or serious side effects (severe rash, syncope, etc.).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Benaglutide<br>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<br>* 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.<br>* Other names: rhGLP-1(7-36);|
| Active Comparator: Liraglutide<br>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<br>* 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.<br>* Other names: Victoza;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Change at 3 months | Measured in kilograms | baseline and 3 months | 
| Gut microbiota composition | 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). | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in waist circumference | Measured in cm | baseline and 3 months | 
| Change in systolic blood pressure | Measured in mmHg | baseline and 3 months | 
| Change in diastolic blood pressure | Measured in mmHg | baseline and 3 months | 
| Change in HbA1c | Measured in % | baseline and 3 months | 
| Change in plasma glucose | Measured in mmol/l | baseline and 3 months | 
| Change in insulin | Measured in μU/ml | baseline and 3 months | 
| Change in lipids-total cholesterol | Measured in mmol/l | baseline and 3 months | 
| Change in lipids-low density lipoprotein cholesterol | Measured in mmol/l | baseline and 3 months | 
| Change in lipids-high density lipoprotein cholesterol | Measured in mmol/l | baseline and 3 months | 
| Change in lipids-triglycerides | Measured in mmol/l | baseline and 3 months | 
| Change in lipids-free fatty acids | Measured in μmol/l | baseline and 3 months | 
| Change in Uric Acid | Measured in mmol/l | baseline and 3 months | 
| Change in interleukin-10 | Measured in mmol/l | baseline and 3 months | 
| Change in tumor necrosis factor | Measured in mmol/l | baseline and 3 months |