XW004 To Evaluate the Safety, Tolerability, PK, and PD of Oral Ecnoglutide Tablet in Healthy Adults

Sponsor
Sciwind Biosciences APAC CO Pty. Ltd.
Study ID
NCT05184322
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

Study Details

XW004 is an acylated human glucagon-like peptide 1 (GLP-1) analogue and is being developed for type 2 diabetes mellitus (T2DM) and obesity management.

Key Dates

Start date
Apr 12, 2022
Status verified
Nov 2024
Primary completion
Jul 13, 2024
Completion
Mar 25, 2025

Study Design

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

Arms

  • Experimental: Cohort 1A/1B
    Cohort 1A/1B will enroll 14 healthy participants.
  • Experimental: Cohort 2
    Cohort 2 will enroll 14 healthy participants.
  • Experimental: Cohort 3
    Cohort 3 will enroll 14 healthy participants.
  • Experimental: Cohort 4
    Cohort 4 will enroll 14 otherwise healthy participants with obesity.
  • Experimental: Cohort 5
    Cohort 5 will enroll 14 otherwise healthy participants with obesity.
  • Experimental: Cohort 6
    Cohort 6 will enroll 14 otherwise healthy participants with obesity.

Primary Outcome Measure

Number and percentage of treatment emergent adverse events (TEAEs) and serious adverse events (SAE) [ Time Frame: Up to 98 days ]

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