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)
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
623
ZHONGSHAN Hospital
Shanghai, Shanghai Municipality, China
Change from baseline in HbA1c
Time frame: Baseline, week 32
Change from baseline in HbA1c
Time frame: Baseline, Week 5, Week 9, Week 13, Week 17, Week 25, Week 43 and Week 52
Change from baseline in fasting plasma glucose (FPG)
Time frame: Baseline, Week 32 and Week 52
Change from baseline in lipid panel
Time frame: Baseline, Week 32 and Week 52
Change from baseline in body weight
Time frame: Baseline, Week 32 and Week 52
Pharmacokinetics: plasma trough level of XW003
Time frame: Baseline, Day 29, Day 57, Day 85, Day 224, Day 364 and Day 399
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Administered orally