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

What Was Tested

This registered phase 1 trial tested Ecnoglutide.

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.

It had six arms (groups): Cohort 1A/1B (experimental), Cohort 2 (experimental), Cohort 3 (experimental), Cohort 4 (experimental) and Cohort 5 (experimental).

Cohort 1A/1B will enroll 14 healthy participants.

Cohort 2 will enroll 14 healthy participants.

Cohort 3 will enroll 14 healthy participants.

The registry classes the interventions as drug.

More on the Plan

The study is designed to evaluate the safety, tolerability, PK, and PD of oral ecnoglutide tablet in healthy participants.

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.

Who Took Part

87 actual participants took part.

It was open to people of any sex aged from 18 years up to 55 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Healthy male or female participants, aged 18 to 55 years (inclusive at the time of informed consenting);.

The full record lists 4 inclusion and 3 exclusion criteria; among the exclusions: personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2;.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

Because people in this Ecnoglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Ecnoglutide group and the comparison group ran side by side rather than switching.

As a double-blind Ecnoglutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2022-04-12 with completion listed for 2024-07-13.

It ran at 1 site in Australia.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Number and percentage of treatment emergent adverse events (TEAEs) and serious adverse events (SAE) (time frame: Up to 98 days).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Ecnoglutide in 87 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Ecnoglutide compound page, all human trials.