NCT05680155

A Phase 3 Study to Evaluate the Efficacy of XW003 Compared With Placebo in T2DM Patients

A Phase 3, Multi-center, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of XW003 in Patients With T2DM Inadequately Controlled by Diet and Exercise Alone

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 211 (actual)
• Sponsor: Hangzhou Sciwind Biosciences Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to investigate the efficacy and safety of XW003 versus placebo in patients with type 2 diabetes mellitus (T2DM) inadequately controlled by diet and exercise alone

Detailed description

In this Phase 3 study, eligible participants will be randomized in a 2:2:1:1 ratio to receive once-weekly subcutaneous XW003 (high or low dose) or volume matching placebo as an adjunct to lifestyle intervention for 24 weeks. The core treatment phase will be followed by a 28-week open-label period where all participants receive XW003.

Conditions

• T2DM
• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Ecnoglutide	Subcutaneous Injection
DRUG	Placebo	Subcutaneous Injection with matched volume

Timeline

• Start date: 2022-12-29
• Primary completion: 2024-06-12
• Completion: 2024-10-12
• First posted: 2023-01-11
• Last updated: 2025-09-10

Locations

1 site across 1 country: China