A Phase Ib/IIa Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral Ecnoglutide Tablets in Chinese Participants With Overweight or Obesity

What Was Tested

In this phase 1, phase 2 trial, researchers set out to test Ecnoglutide.

It had six arms (groups): one (experimental), one (experimental), one (experimental), one (experimental) and one (placebo comparator).

Once daily.

Once daily.

Once weekly.

The registry classes the interventions as drug.

Who Took Part

The registry lists 126 planned participants were the target.

It was open to people of any sex aged from 18 years up to 65 years.

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

The full record lists 2 inclusion and 7 exclusion criteria; among the exclusions: diagnosis of overweight or obesity due to endocrine disorders , such as cushing's syndrome;; history of major gastrointestinal surgery (except cholecystectomy or appendectomy), or metabolic surgery, or plan to undergo major surgery during the study period;.

How the Study Was Run

Design: randomized, parallel-group and quadruple-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.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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

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

It started in 2025-11-18 with completion listed for 2027-01-05.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: The incidence and severity of adverse events (time frame: up to day 204).

It also tracked 10 secondary outcomes, for example Change of body weight from baseline, Change of BMI from baseline, Change of waist circumference from baseline, Change of hip circumference from baseline, Change of neck circumference from baseline and Change of waist/hip ratio from baseline.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of Ecnoglutide in 126 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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