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

• Status: Not yet recruiting
• Trial end date: 2024-10-03
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hangzhou Sciwind Biosciences Co., Ltd.
• Treatments: Dulaglutide; Metformin

Criteria

Inclusion Criteria:

1. Ability and willingness to participate in the study, give written informed consent, and comply with the study specific requirements and all protocol procedures

2. Sex: male or female; Age: 18 to 75 years, inclusive

3. BMI: 20.0 kg/m^2 to 35.0 kg/m^2, inclusive

4. 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.

5. HbA1c ranging from 7.5% to 11.0% at screening, inclusive

6. FPG ≤13.9 mmol/L at screening

Exclusion Criteria:

1. History of type 1 or other types of diabetes mellitus

2. Use of insulin during the 6 months preceding screening

3. History of proliferative diabetic retinopathy, diabetic maculopathy, diabetic neuropathy, or diabetic foot during the 6 months prior to screening.

4. History of acute or chronic pancreatitis or high-risk factors for pancreatitis

5. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2.

6. History of stomach surgeries or disorders associated with slowed emptying of the stomach during the past 6 months.

7. History of heart attack, stroke or congestive heart failure of Grade 3 or 4 in the past 6 months.