Effects of XW003 Versus Liraglutide on Body Weight of Adult Participants With Obesity

What Was Tested

In this phase 2 trial, researchers set out to test Liraglutide and Ecnoglutide.

XW003 is an acylated human glucagon-like peptide 1 (GLP-1) analogue and is being developed for type 2 diabetes mellitus (T2DM) and obesity management.

It had four arms (groups): Cohort A (experimental), Cohort B (experimental), Cohort C (experimental) and Cohort D (active comparator).

The registry classes the interventions as drug.

More on the Plan

The study treatment period for 4 groups in the study will be divided into the four Titration Treatment periods and one Core Treatment period.

The overall duration of the study treatment for each group will be 26 weeks.

The duration of Titration Treatment will be up to 14 weeks for the three groups of XW003 treatment but 4 weeks for Saxenda group.

Approximately 250 participants who are adults with obesity, in the absence of type 2 or any other type of diabetes, are planned to be screened.

Who Took Part

The registry lists 206 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Male or female, aged 18 to 70 years (inclusive at the time of informed consent);. Participants must have a BMI ≥ 30.0 kg/m2 and ≤40.0 kg/m2 at Screening;. Participants must have the ability and willingness to attend the necessary visits to the clinical research unit (CRU);. Participants must be willing and able to provide written informed consent after the nature of the study has been explained and prior to the commencement of any study procedures.

The full record lists 7 inclusion and 36 exclusion criteria; among the exclusions: obesity induced by endocrine disorders (e.g., cushing syndrome);; calcitonin ≥50 ng/l (pg/ml) at screening;; history of severe allergic or hypersensitivity to any of the investigational products or its excipients or to drugs of similar chemical classes;.

How the Study Was Run

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

Because people in this Liraglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

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

It started in 2021-11-30 with completion listed for 2022-11-16.

It ran at 1 site in Australia.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Percentage change in participants body weight (%) from the Baseline (time frame: Week 26).

It also tracked 18 secondary outcomes, for example Absolute change in body weight (kg) of participants, Changes in waist circumference and hip circumference (cm) in participants, Change in BMI in participants, Change in fasting plasma glucose (FPG), Change in fasting serum insulin and Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Liraglutide and Ecnoglutide in 206 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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