A Drug-Drug Interaction Study Between XW003 and Metformin, Warfarin, Rosuvastatin or Digoxin

What Was Tested

The trial (phase 1) is built around Ecnoglutide.

This is a study of a drug-drug interaction between XW003 and Metformin, Warfarin, Rosuvastatin or Digoxin.

It had two arms (groups): Trial Group 1: Metformin and Warfarin administered before and with XW003 treatment (experimental) and Trial Group 2: Rosuvastatin and Digoxin administered before and with XW003 treatment (experimental).

The registry classes the interventions as drug.

More on the Plan

Approximately 56 healthy subjects are to be enrolled into 2 parallel trial groups, with 28 subjects and 2 drugs evaluated in each of the trial group.

Who Took Part

Enrollment: 57 actual participants took part.

It was open to people of any sex aged from 18 years up to 45 years.

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

Examples of who could join: Male or female, 18-45 years old, inclusive;. BMI: 20.0 to 30.0 kg/m2 , body weight: ≥50.0kg. Ability and willingness to participate in the study, give written informed consent, and comply with the study requirements and all protocol procedures.

The full record lists 3 inclusion and 6 exclusion criteria; among the exclusions: history of allergic diseases including asthma, urticaria or eczema, or history of sensitivity to glp-1 products, digoxin, warfarin, rosuvastatin or metformin;; known difficulty in swallowing tablets or history of gastrointestinal diseases affecting drug absorption;; history of receiving any procedures that might affect drug absorption, distribution, metabolism or excretion;.

How the Study Was Run

The set-up was non-randomized, sequential and open-label.

Everyone knew when Ecnoglutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2023-07-14 with completion listed for 2024-01-08.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 1, non-randomized trial of Ecnoglutide in 57 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.