The Effect and the Pharmacogenomics Study of Liraglutide in Obese Patients

What Was Tested

The trial (phase 2) is built around Liraglutide.

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.

It had two arms (groups): Liraglutide (experimental) and Liraglutide combined with metformin (experimental).

The registry classes the interventions as drug.

More on the Plan

Background:The rapid growth of obese or overweight people in the world has become a major social problem.

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.

Who Took Part

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Patients aged 18 to 65 years (to the date of screening)；. 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).

The full record lists 4 inclusion and 7 exclusion criteria; among the exclusions: pregnant female; severe cardiovascular and cerebrovascular diseases (heart failure, myocardial infarction, acute hemorrhagic or ischemic encephalopathy), pulmonary heart disease or pulmonary insufficiency, renal failure, severe hepatitis; combined with acute complications of diabetes such as ketoacidosis, lactic acidosis, hyperosmolar state of diabetes.

How the Study Was Run

It was run as a non-randomized, parallel-group and open-label study.

The Liraglutide group and the comparison group ran side by side rather than switching.

Being open-label, the Liraglutide study did not mask who received what.

It started in 2017-12-01 with completion listed for 2020-12-01.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Weight Change at 3 months (time frame: baseline and 3 months). Genotype (time frame: baseline).

It also tracked 13 secondary outcomes, for example Change in waist circumference, Change in systolic blood pressure, Change in diastolic blood pressure, Change in HbA1c, Change in plasma glucose and Change in insulin.

What This Means in Plain Language

Put simply, this is a phase 2, non-randomized trial of Liraglutide in people.

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Liraglutide compound page, all human trials.