A Study to Evaluate the Safety and Efficacy of NG101 in Adult Participants Receiving a Glucagon-like Peptide-1 (GLP-1) Agonist

What Was Tested

This registered phase 2 trial tested Semaglutide.

On Day 2, all participants will receive a single subcutaneous injection of a Glucagon-like Peptide-1 (GLP-1) agonist (semaglutide).

Participants will remain at the clinical research unit for the duration of the treatment period.

It had two arms (groups): one (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 120 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: Male or female. BMI between 22 - 35 kg/m2 at screening.

The full record lists 3 inclusion and 3 exclusion criteria; among the exclusions: presence or history of illness that might confound the results of the study or pose an -; history of presence of gastroparesis, gallbladder disease, acute or chronic pancreatitis, or surgery of the abdomen; history or presence of type 1 or type 2 diabetes.

How the Study Was Run

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

Because people in this Semaglutide 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 Semaglutide.

Those kept unaware of assignments: participant and investigator.

It started in 2024-06-24 with completion listed for 2024-09-04.

It ran at 1 site in United States.

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): Duration of GI-related adverse events (time frame: 96 hours following GLP-1 agonist injection). Severity of GI-related adverse events (time frame: 96 hours following GLP-1 agonist injection).

It also tracked 1 secondary outcome, for example Number of TEAEs of GI-related adverse events.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Semaglutide in 120 people.

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

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