A Phase 3 Study to Evaluate the Efficacy of XW003 Compared With Placebo in T2DM Patients

What Was Tested

This registered phase 3 trial tested Ecnoglutide.

It had four arms (groups): C1-XW003 (experimental), C1-Placebo (placebo comparator), C2-XW003 (experimental) and C2-Placebo (placebo comparator).

Matched Placebo once weekly.

The registry classes the interventions as drug.

More on the Plan

The core treatment phase will be followed by a 28-week open-label period where all participants receive XW003.

Who Took Part

The registry lists 211 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Ability and willingness to participate in the study, give written informed consent, and comply with the study specific requirements and all protocol procedures. Sex: male or female; Age: 18 to 75 years, inclusive. BMI: 20.0 kg/m\^2 to 35.0 kg/m\^2, inclusive. Have been diagnosed with T2DMthat is inadequately controlled with at least 3 months of diet and exercise prior to screening.

The full record lists 6 inclusion and 7 exclusion criteria; among the exclusions: history of type 1 or other types of diabetes mellitus; use of any glp-1 analogue during the 3 months preceding to screening; history of proliferative diabetic retinopathy, diabetic maculopathy, diabetic neuropathy, or diabetic foot during the 6 months preceding screening.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

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.

Neither the participants nor the staff measuring them knew who was on Ecnoglutide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2022-12-29 with completion listed for 2024-06-12.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change from baseline in HbA1c (time frame: Baseline, Week 24).

It also tracked 13 secondary outcomes, for example Change from baseline in HbA1c, Change from baseline in fasting plasma glucose (FPG), Change from baseline in fasting insulin, Change from baseline in lipid panel, Change from baseline in 2-hour postprandial blood glucose and Change from baseline in 7-point self-monitored blood glucose.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Ecnoglutide in 211 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.