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

• Status: Not yet recruiting
• Trial end date: 2024-10-21
• Target enrollment: 0
• Participant gender: All

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

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

Details

• Lead Sponsor: Hangzhou Sciwind Biosciences Co., Ltd.

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 T2DMthat is inadequately controlled with at least 3 months of diet and exercise 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 any GLP-1 analogue during the 3 months preceding to screening.

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