NCT05184322

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

A Phase 1, Randomised, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral Ecnoglutide Tablet in Healthy Adult Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: Sciwind Biosciences APAC CO Pty. Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Obesity
• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	T2026	Once daily for 15 days.
DRUG	Placebo	Once daily for 15 days.
DRUG	Oral ecnoglutide tablet	Once daily for 6 weeks.
DRUG	Oral ecnoglutide tablet	Once daily and titrated up in concentration to once every week during maintenance period.
DRUG	Oral ecnoglutide tablet	Once daily for 15 days.
DRUG	Oral ecnoglutide tablet	Once daily for 15 days.
DRUG	Oral ecnoglutide tablet	Once daily for 15 days.
DRUG	Oral ecnoglutide tablet	Once daily for 15 days.
DRUG	T2026	Once daily for 6 weeks.
DRUG	Placebo	Once daily for 6 weeks.
DRUG	T2026	Once daily to once weekly for 12 weeks.
DRUG	Placebo	Once daily to once weekly for 12 weeks.

Timeline

• Start date: 2022-04-12
• Primary completion: 2024-07-13
• Completion: 2025-03-25
• First posted: 2022-01-11
• Last updated: 2025-09-10

Locations

1 site across 1 country: Australia