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

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.

Inclusion criteria

• Ability and willingness to participate in the study, give written informed consent, and comply with the study specific requirements and all protocol procedures.
• Sex: male or female; Age: 18 to 75 years, inclusive
• BMI: 20.0 kg/m^2 to 35.0 kg/m^2, inclusive
• Have been diagnosed with T2DMthat is inadequately controlled with at least 3 months of diet and exercise prior to screening.
• HbA1c ranging from 7.5% to 11.0% at screening, inclusive
• FPG ≤13.9 mmol/L at screening.

Exclusion criteria

• History of type 1 or other types of diabetes mellitus.
• Use of any GLP-1 analogue during the 3 months preceding to screening.
• History of proliferative diabetic retinopathy, diabetic maculopathy, diabetic neuropathy, or diabetic foot during the 6 months preceding screening.
• History of acute or chronic pancreatitis or high risk factors for pancreatitis.
• Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2.
• History of stomach surgeries or disorders associated with slowed emptying of the stomach during the past 6 months.
• History of heart attack, stroke, or congestive heart failure of Grade 3 or 4 in the past 6 months.