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

What Was Tested

The trial (phase 3) is built around Exenatide and Liraglutide.

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.

It had three arms (groups): Liraglutide (experimental), Exenatide (experimental) and Exenatide Microspheres for Injection (experimental).

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

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

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

The registry classes the interventions as drug.

Who Took Part

The registry lists 150 planned participants were the target.

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

The set-up was randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Exenatide and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Everyone knew when Exenatide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2018-09-01 with completion listed for 2022-09-01.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Weight Change at 3 months (time frame: baseline , 3 months).

It also tracked 14 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 3, randomized trial of Exenatide and Liraglutide in 150 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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