Effects of GLP-1RA on Body Weight, Metabolism and Fat Distribution in Overweight/Obese Patients With Type 2 Diabetes Mellitus

Plain-language guide to NCT05779644: not phased randomized trial of Semaglutide and Liraglutide, fatty liver & elevated liver enzymes, 300 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT05779644
Phase: not phased
Status: status unknown
Start: 2023-02-23
Completion (planned or actual): 2025-02-23
Participants: 300 (estimated)
Design: randomized, open label (everyone knows who gets what), treatment
Conditions studied: Metformin; Obesity, Abdominal; Diabetes Mellitus, Type 2; Abdominal Fat; Non-Alcoholic Fatty Liver Disease; Metabolism Disorder, Glucose
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

The trial (not phased) is built around Semaglutide and Liraglutide for fatty liver & elevated liver enzymes.

The purpose of this study is to analyze the effects of GLP-1RA on blood glucose, body weight, glucose and lipid metabolism and fat distribution in overweight/obese patients with type 2 diabetes mellitus.

It had three arms (groups): Liraglutide group (experimental), Semaglutide group (experimental) and Metformin group (experimental).

Liraglutide is injected once a day.

Semaglutide is injected once a week.

Metformin is taken orally daily.

The registry classes the interventions as drug.

More on the Plan

The metabolomic changes of overweight/obese patients with type 2 diabetes before and after medication and the differences among the three groups will be analyzed.

Explore the correlation between visceral fat content, glucose and lipid metabolism, inflammatory factors and other biochemical indicators and metabolomics.

Who Took Part

The registry lists 300 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: Aged 18-65 years old. BMI≥24kg/㎡, or waist circumference: \> 85cm (for male) or \> 80cm (for female). Has been diagnosed with type 2 diabetes mellitus. Not received any drugs affecting glucose and lipid metabolism or weight loss surgery in the past one month.

The full record lists 5 inclusion and 11 exclusion criteria; among the exclusions: abnormal weight gain caused by other endocrine diseases; severe metabolic diseases, such as diabetic ketoacidosis, hypertonic hyperglycemia; type 1 diabetes or other special types of diabetes.

How the Study Was Run

Design: randomized, parallel-group and open-label.

The fatty liver & elevated liver enzymes participants were allocated by chance, so the Semaglutide group and the comparison group should start out alike.

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

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

It started in 2023-02-23 with completion listed for 2025-02-23.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Blood glucose (time frame: The twelfth week of treatment). Blood insulin (time frame: The twelfth week of treatment). Total cholesterol (time frame: The twelfth week of treatment).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Semaglutide and Liraglutide in 300 people with fatty liver & elevated liver enzymes.

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

More context: the Semaglutide compound page and the Liraglutide compound page, Fatty liver & elevated liver enzymes research.

Our Notes on the Compounds

Semaglutide: The active ingredient in several prescription GLP-1 receptor agonist medicines (Ozempic, Wegovy, oral tablets).

Liraglutide: A once-daily GLP-1 receptor agonist peptide; sold as Victoza for type 2 diabetes and Saxenda for weight management.

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.