Effects of GLP-1 RAs on Weight and Metabolic Indicators in Obese Patients

Central South University

Status and phase: Unknown; Phase 3

Conditions: Obesity

Treatments: Drug: Exenatide Microspheres for Injection; Drug: Liraglutide; Drug: Exenatide

Study type: Interventional

Funder types: Other

Identifiers

NCT03671733

201806897

Details and patient eligibility

About

This studay evaluates the effect of the glucagon-like peptide-1 (GLP-1) receptor agonist,including Liraglutide,Exenatide and Exenatide Microspheres for Injection,in the treatment of subjects who are overweight or obese.

Enrollment: 150 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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150 participants in 3 patient groups

Liraglutide

Experimental group

Description:

Administered subcutaneously (s.c., under the skin) once daily for 12 weeks.

Treatment:

Drug: Liraglutide

Exenatide

Experimental group

Description:

Administered subcutaneously (s.c., under the skin) twice daily for 12 weeks.

Treatment:

Drug: Exenatide

Exenatide Microspheres for Injection

Experimental group

Description:

Administered subcutaneously (s.c., under the skin) once weekly for 12 weeks.

Treatment:

Drug: Exenatide Microspheres for Injection