A Phase 3 Study to Evaluate the Efficacy of XW003 in Adults With Overweight or Obesity

What Was Tested

In this phase 3 trial, researchers set out to test Ecnoglutide.

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

Matched Placebo once weekly.

The registry classes the interventions as drug.

Who Took Part

The registry lists 664 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: Male or female, 18-75 years old, inclusive;. Willing and able to maintain stable diet and exercise during the study period.

The full record lists 4 inclusion and 7 exclusion criteria; among the exclusions: obesity induced by endocrine diseases such as hypothyroidism, cushing syndrome, etc; history of bariatric surgery (except liposuction \>1 year ago) or planned bariatric surgery during the study period; within 3 months before screening, history of using the following drugs or treatments:.

How the Study Was Run

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

The participants were allocated by chance, so the Ecnoglutide group and the comparison group should start out alike.

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

Blinding on both sides kept the participants and researchers unaware of who received Ecnoglutide.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2023-04-05 with completion listed for 2024-06-20.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Percent change in body weight from baseline (time frame: Week 40).

It also tracked 4 secondary outcomes, for example Percent and absolute body weight change from baseline, Change from baseline in BMI and Change from baseline in waist and hip circumferences.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Ecnoglutide in 664 people.

With 664 participants it is a large trial for this field.

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.