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

NCT ID: NCT03671733

Last Updated: 2021-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-01

Study Completion Date

2022-09-01

Brief Summary

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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

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Liraglutide

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

Group Type EXPERIMENTAL

Liraglutide

Intervention Type DRUG

The treatment of Liraglutide lasted three months,During the first week: 0.6mg per day, subcutaneous injection;During the second week: 1.2mg per day, subcutaneous injection; From third week onwards, 1.8mg per day, subcutaneous injection.

Exenatide

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

Group Type EXPERIMENTAL

Exenatide

Intervention Type DRUG

10mcg once a day for 4 weeks increased to 10mcg twice a day for 8 weeks.

Exenatide Microspheres for Injection

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

Group Type EXPERIMENTAL

Exenatide Microspheres for Injection

Intervention Type DRUG

Exenatide 2 mg injection once weekly for 12 weeks.

Interventions

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Liraglutide

The treatment of Liraglutide lasted three months,During the first week: 0.6mg per day, subcutaneous injection;During the second week: 1.2mg per day, subcutaneous injection; From third week onwards, 1.8mg per day, subcutaneous injection.

Intervention Type DRUG

Exenatide

10mcg once a day for 4 weeks increased to 10mcg twice a day for 8 weeks.

Intervention Type DRUG

Exenatide Microspheres for Injection

Exenatide 2 mg injection once weekly for 12 weeks.

Intervention Type DRUG

Other Intervention Names

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Victoza Byetta Bydureon

Eligibility Criteria

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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.).
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xiangya Hospital of Central South University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Xiangya Hospital of Central South University

Changsha, Hunan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jing Wu

Role: CONTACT

+86-13574120508

Facility Contacts

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Jing Wu

Role: primary

+86-13574120508

Other Identifiers

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201806897

Identifier Type: -

Identifier Source: org_study_id

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