NCT05680129

A Phase 3 Study to Evaluate the Efficacy of XW003 Compared With Dulaglutide in Participants With T2DM

A Phase 3, Multi-center, Open-label, Randomized Study to Evaluate the Efficacy and Safety of XW003 Versus Dulaglutide in Patients With T2DM Inadequately Controlled by Metformin

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 623 (actual)
• Sponsor: Hangzhou Sciwind Biosciences Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to compare the efficacy and safety of two XW003 doses versus dulaglutide as add-on therapy to metformin in participants with type 2 diabetes mellitus (T2DM)

Detailed description

In this Phase 3 study, eligible participants will be randomized in a 1:1:1 ratio to receive once-weekly subcutaneous XW003 (high or dose) or active comparator dulaglutide as add-on to metformin treatment for 52 weeks, including a dose-escalation period.

Conditions

• T2DM
• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Ecnoglutide high dosage	Administered subcutaneously
DRUG	Ecnoglutide low dosage	Administered subcutaneously
DRUG	Dulaglutide	Administered subcutaneously
DRUG	Metformin	Administered orally

Timeline

• Start date: 2023-01-10
• Primary completion: 2024-07-03
• Completion: 2024-10-12
• First posted: 2023-01-11
• Last updated: 2025-05-08

Locations

1 site across 1 country: China