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

Phase 3

• Conditions: Obesity
• Interventions: Drug: Exenatide Microspheres for Injection; Drug: Exenatide; Drug: Liraglutide

• Registration Number: NCT03671733
• Lead Sponsor: Xiangya Hospital of Central South University

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-09-01
• Study First Submitted: 2018-09-12
• Study First Submitted QC: 2018-09-12
• Study First Posted: 2018-09-14
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-07
• Last Update Posted: 2021-04-09
• Primary Completion: 2022-09-01
• Study Completion: 2022-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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%).

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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.).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exenatide Microspheres for Injection	Exenatide Microspheres for Injection	Administered subcutaneously (s.c., under the skin) once weekly for 12 weeks.
Exenatide	Exenatide	Administered subcutaneously (s.c., under the skin) twice daily for 12 weeks.
Liraglutide	Liraglutide	Administered subcutaneously (s.c., under the skin) once daily for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Weight Change at 3 months	baseline , 3 months	Measured in kilograms

Secondary Outcome Measures

Name	Time	Method
Change in systolic blood pressure	baseline and 3 months	Measured in mmHg
Change in waist circumference	baseline and 3 months	Measured in cm
Change in diastolic blood pressure	baseline and 3 months	Measured in mmHg
Change in HbA1c	baseline and 3 months	Measured in %
Change in insulin	baseline and 3 months	Measured in μU/ml
Change in lipids-total cholesterol	baseline and 3 months	Measured in mmol/l
Change in lipids-low density lipoprotein cholesterol	baseline and 3 months	Measured in mmol/l
Change in lipids-high density lipoprotein cholesterol	baseline and 3 months	Measured in mmol/l
Change in Uric Acid	baseline and 3 months	Measured in mmol/l
Change in tumor necrosis factor	baseline and 3 months	Measured in mmol/l
Change in plasma glucose	baseline and 3 months	Measured in mmol/l
Change in lipids-triglycerides	baseline and 3 months	Measured in mmol/l
Change in lipids-free fatty acids	baseline and 3 months	Measured in μmol/l
Change in interleukin-6	baseline and 3 months	Measured in mmol/l

Trial Locations

Locations (1)

Xiangya Hospital of Central South University; 🇨🇳 Changsha, Hunan, China