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

Sponsor
Hangzhou Sciwind Biosciences Co., Ltd.
Study ID
NCT05680129
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Ecnoglutide high dosage — DRUG
    Administered subcutaneously
  • Ecnoglutide low dosage — DRUG
    Administered subcutaneously
  • Dulaglutide — DRUG
    Administered subcutaneously
  • Metformin — DRUG
    Administered orally

Study Details

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)

Key Dates

Start date
Jan 10, 2023
Status verified
Jul 2023
Primary completion
Jul 3, 2024
Completion
Oct 12, 2024

Study Design

Enrollment
623 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: B1: XW003+MET
    High dosage of XW003 once weekly
  • Experimental: B2: XW003+MET
    Low dosage of XW003 once weekly
  • Active Comparator: B3: Dulaglutide+MET
    1.5mg Dulaglutide once weekly

Primary Outcome Measure

Change from baseline in HbA1c [ Time Frame: Baseline, week 32 ]

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