The Effect and the Pharmacogenomics Study of Liraglutide in Obese Patients

Phase 2

Withdrawn

• Conditions: Obesity
• Interventions: Drug: Liraglutide;metformin; Drug: Liraglutide

• Registration Number: NCT04839237
• Lead Sponsor: Xiangya Hospital of Central South University

Brief Summary

This studay evaluates the effect of liraglutide in the treatment of obese patients ande the influence of genetic factors on the curative effect.Half of participants will receive Liraglutide alone,while the other half who can not achieving adequate glycaemic control will receive Liraglutide and metformin in combination.

Detailed Description

Background:The rapid growth of obese or overweight people in the world has become a major social problem. Obese often associated with kinds of metabolic disorders, especially type 2 diabetes, and Liraglutide can effectively reduce weight and improve blood glucose.Previous studies have indicated that most patients will experience different degrees of weight loss after using Liraglutide, but there is also a small number of patients with no significant weight loss.The gene polymorphism among individuals may affect the weight loss effect of Liraglutide.

Objectives：1.To find the relationships between genetic variants and the response of Liraglutide to treatment of obese patients.2.To investigate the effects of Liraglutide on weight, metabolism (blood glucose, blood lipid, uric acid, etc.) and gut microbiota in obese Chinese patients.

Intervention:Half of participants will receive Liraglutide alone,while the other half who can not achieving adequate glycaemic control will receive Liraglutide and metformin in combination.

Study Timeline

• Study Start: 2017-12-01
• Study First Submitted: 2018-03-27
• Primary Completion: 2020-12-01
• Status Verified: 2021-04
• Study First Submitted QC: 2021-04-08
• Last Update Submitted: 2021-04-08
• Study First Posted: 2021-04-09
• Last Update Posted: 2021-04-09
• Study Completion: 2021-12-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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
Liraglutide combined with metformin	Liraglutide;metformin	Obese patients with HbA1C ≥9.0%, receive Liraglutide in combination with metformin for 3 months.
Liraglutide	Liraglutide	Obese patients with HbA1C lower than 9.0%,receive Liraglutide alone for 3 months.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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 plasma glucose	baseline and 3 months	Measured in mmol/l
Change in systolic blood pressure	baseline and 3 months	Measured in mmHg
Change in lipids-total 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 insulin	baseline and 3 months	Measured in μU/ml
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 lipids-low density lipoprotein cholesterol	baseline and 3 months	Measured in mmol/l
Gut microbiota composition	3 months	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).
Change in Uric Acid	baseline and 3 months	Measured in mmol/l

Trial Locations

Locations (1)

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