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

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.

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 T2DM for at least 3 months and treated with a stable dose of metformin (≥1500 mg/day) in addition to diet and exercise during the 8 weeks 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 insulin during the 6 months preceding screening
• History of proliferative diabetic retinopathy, diabetic maculopathy, diabetic neuropathy, or diabetic foot during the 6 months prior to 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.