NCT05111912

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

A Phase 2, Open-label, Randomised, Dose-Finding Study of XW003, Once-Weekly Human Glucagon-Like Peptide 1 Analogue, Compared With Once-Daily Liraglutide 3 mg in Adult Participants With Obesity

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 206 (actual)
• Sponsor: Sciwind Biosciences APAC CO Pty. Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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. Based on a 20% screening failure rate, a total of 200 participants are expected to be enrolled for the four groups.

Conditions

• Obesity

Interventions

Type	Name	Description
DRUG	XW003	XW003 (from 0.2 mg to 1.2 mg, 1.8 mg, and 2.4 mg once weekly), should take place during the first 14 weeks after randomization as described: Dose Escalation Schedule of Investigational Product (XW003). All eligible participants assigned to the XW003 study groups should aim to reach the respective final target dose of XW003 at 1.2 mg, 1.8 mg, or 2.4 mg once weekly.
DRUG	Saxenda	If a participant does not tolerate the recommended target dose of Saxenda group (e.g., 3.0 mg once daily), the participant may stay at the preceding highest tolerable dose (e.g., 2.4 mg once daily).

Timeline

• Start date: 2021-11-30
• Primary completion: 2022-11-16
• Completion: 2022-12-20
• First posted: 2021-11-08
• Last updated: 2023-08-21

Locations

1 site across 1 country: Australia