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.
This is a single centre, double-blind, randomised, multiple-dose, placebo-controlled study, including six cohorts (Cohorts 1A/1B, 2, 3, 4, 5, 6) with a semi-parallel design. The study is designed to evaluate the safety, tolerability, PK, and PD of oral ecnoglutide tablet in healthy participants. Participants will undergo a Screening period beginning up to 28 days (Cohort 1 to 4) and 42 days (Cohort 5 and 6 ) prior to randomisation/dose administration and will be required to sign an informed consent form (ICF) before undertaking any study specific procedures or assessments. Participants who meet all of the inclusion and none of the exclusion criteria will be enrolled. Eligible participants will be admitted to the CRU on Day -1 for review of inclusion and exclusion criteria prior to the start of study procedures on Day 1. A Safety Review Committee (SRC) will be established to monitor the progress of this trial and to make recommendations on whether to continue, modify or stop the trial for safety or ethical reasons.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
87
Q-Pharm Pty Ltd (AKA Nucleus Network Brisbane)
Herston, Queensland, Australia
Number and percentage of treatment emergent adverse events (TEAEs) and serious adverse events (SAE)
Count of adverse events
Time frame: Up to 98 days
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Once daily and titrated up in concentration to once every week during maintenance period.
Once daily for 15 days.
Once daily for 15 days.
Once daily for 15 days.
Once daily for 15 days.
Once daily for 6 weeks.
Once daily for 6 weeks.
Once daily to once weekly for 12 weeks.
Once daily to once weekly for 12 weeks.