Effects of Benaglutide on Weight and Gut Microbiota in Obese Patients

Central South University

Status and phase: Unknown; Phase 3

Conditions: Obesity

Treatments: Drug: Liraglutide; Drug: Benaglutide

Study type: Interventional

Funder types: Other

Identifiers

NCT03986008

2019050125

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Benaglutide

Experimental group

Description:

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.

Treatment:

Drug: Benaglutide

Liraglutide

Active Comparator group

Description:

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.

Treatment:

Drug: Liraglutide