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

Sponsor
Hangzhou Sciwind Biosciences Co., Ltd.
Study ID
NCT05680155
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Ecnoglutide — DRUG
    Subcutaneous Injection
  • Placebo — DRUG
    Subcutaneous Injection with matched volume

Study Details

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

Key Dates

Start date
Dec 29, 2022
Status verified
Jul 2023
Primary completion
Jun 12, 2024
Completion
Oct 12, 2024

Study Design

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

Arms

  • Experimental: C1-XW003
    High dosage of XW003 once weekly
  • Placebo Comparator: C1-Placebo
    Matched Placebo once weekly
  • Experimental: C2-XW003
    Low dosage of XW003 once weekly
  • Placebo Comparator: C2-Placebo
    Matched Placebo once weekly

Primary Outcome Measure

Change from baseline in HbA1c [ Time Frame: Baseline, Week 24 ]

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