A Phase 3 Study to Evaluate the Efficacy of XW003 in Adults With Overweight or Obesity

Sponsor
Hangzhou Sciwind Biosciences Co., Ltd.
Study ID
NCT05813795
Phase
PHASE3
Status
Completed

Conditions

  • Weight Management

Eligibility Criteria

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

Interventions

  • Ecnoglutide Low Dosage — DRUG
    Subcutaneous Injection
  • Ecnoglutide Medium Dosage — DRUG
    Subcutaneous Injection
  • Ecnoglutide High Dosage — DRUG
    Subcutaneous Injection
  • Placebo — DRUG
    Subcutaneous Injection with matched volume

Study Details

The aim of the study is to evaluate the efficacy and safety of XW003 versus placebo in adults with overweight or obesity

Key Dates

Start date
Apr 5, 2023
Status verified
Jul 2024
Primary completion
Jun 20, 2024
Completion
Oct 10, 2024

Study Design

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

Arms

  • Experimental: C1- XW003 Low Dosage
    XW003 with low dosage once weekly
  • Placebo Comparator: C1-Placebo
    Matched Placebo once weekly
  • Experimental: C2- XW003 Medium Dosage
    XW003 with medium dosage once weekly
  • Placebo Comparator: C2-Placebo
    Matched Placebo once weekly
  • Experimental: C3- XW003 High Dosage
    XW003 with high dosage once weekly
  • Placebo Comparator: C3-Placebo
    Matched Placebo once weekly

Primary Outcome Measure

Percent change in body weight from baseline [ Time Frame: Week 40 ]

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