A Phase 3 Study to Evaluate the Efficacy of XW003 Compared With Placebo in T2DM Patients
T2DM, Type 2 Diabetes Mellitus
About this trial
This is an interventional treatment trial for T2DM focused on measuring T2DM, Glucagon-like peptide-1, Ecnoglutide, XW003, GLP-1
Eligibility Criteria
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.
Sites / Locations
- Nanjing Drum Tower Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Placebo Comparator
Experimental
Placebo Comparator
C1-XW003
C1-Placebo
C2-XW003
C2-Placebo
High dosage of XW003 once weekly
Matched Placebo once weekly
Low dosage of XW003 once weekly
Matched Placebo once weekly