Phase 1 Study Assessing the Pharmacokinetics of NEX-22A in Subjects With T2D

What Was Tested

This registered phase 1 trial tested Liraglutide.

It had 1 arm (groups): one (experimental).

The registry classes the interventions as drug.

More on the Plan

After being informed about the study and potential risks, all patients given written informed consent will undergo a screening to determine eligibility for study entry.

Each cohort will have a sentinel participant.

NEX-22A will be administered in sequential cohorts.

Blood samples for PK analysis will be withdrawn at specified timepoints over a period of 36 days.

Who Took Part

The registry lists 12 actual participants took part.

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

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

Examples of who could join: Signed and dated informed consent obtained before any trial-related activities. Trial-related activities are any procedures that would not have been done during normal management of the subject. Male or female subject with type 2 diabetes mellitus. Age between 18 and 65 years, both inclusive. Body Mass Index (BMI) between 18.5 and 35.0 kg/m\^2, both inclusive. Diabetes duration of at least 1 year.

The full record lists 7 inclusion and 31 exclusion criteria; among the exclusions: known or suspected hypersensitivity to the imp or any of the excipients or to any component of the imp formulation; previous participation in this trial. participation is defined as being dosed; history of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.

How the Study Was Run

Design: single-group and open-label.

Being open-label, the Liraglutide study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2024-05-27 with completion listed for 2025-07-18.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 30 secondary outcomes, for example Number of subjects with treatment-related adverse events a assessed by frequency, Number of subjects with treatment-related adverse events a assessed by seriouness, Number of subjects with treatment-related adverse events a assessed by intensity and Number of subjects with treatment-related adverse events a assessed by relationship to study treatment.

What This Means in Plain Language

Put simply, this is a phase 1 trial of Liraglutide in 12 people.

Its size is small, so on its own it can only give an early look.

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

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