Loading clinical trials...

Phase 1 Study Assessing the Pharmacokinetics of NEX-22A in Subjects With T2D | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

An Open, Single Ascending Dose, Phase 1 Study to Assess the Pharmacokinetics, Safety, and Tolerability of NEX-22A, a Subcutaneous Prolonged-release Injection, in Male and Female Participants With Type 2 Diabetes

NCT06439056•Nanexa AB

View on ClinicalTrials.gov

Summary

The purpose with the study is to assess pharmacokinetics of NEX-22A in patients with type 2 diabetes.

Detailed Description

The trial is a single-centre, open-label, single ascending dose study. 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 subject will be enrolled in one of the three sequential cohorts, comprising one single dose of NEX-22A liraglutide injection. Each cohort will have a sentinel participant. NEX-22A will be administered in sequential cohorts. Before initiating a new dose cohort, safety, tolerability and PK data for all treated subjects must have been reviewed by the dose escalation committee. Blood samples for PK analysis will be withdrawn at specified timepoints over a period of 36 days

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. 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.
•2. Male or female subject with type 2 diabetes mellitus.
•3. Metformin therapy without change in dose for the last 3 months.
•4. Age between 18 and 65 years, both inclusive.
•5. Body Mass Index (BMI) between 18.5 and 35.0 kg/m\^2, both inclusive.
•6. HbA1c \> 6.5% and \<= 9.0%.
•7. Diabetes duration of at least 1 year.

Exclusion Criteria

•1. Known or suspected hypersensitivity to the IMP or any of the excipients or to any component of the IMP formulation.
•2. Previous participation in this trial. Participation is defined as being dosed.
•3. Receipt of any medicinal product in clinical development within 30 days or at least 5 half-lives of the related substances and their metabolites (whichever is longer) before enrolment in this trial.
•4. History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.
•5. Any history or presence of cancer except basal cell skin cancer or squamous cell skin cancer as judged by the investigator.
•6. Clinically relevant comorbidity, capable of constituting a risk for the subject when participating in the trial or of interfering with the interpretation of data.
•7. Signs of acute illness as judged by the investigator.
•8. Any serious systemic infectious disease during four weeks prior to first dosing of the trial drug, as judged by the investigator.
•9. Subjects with dermatological conditions, tattoos or large scars on the abdomen that would limit the evaluation of local tolerability, as judged by the investigator.
•10. Clinically significant abnormal values for haematology, biochemistry, coagulation, or urinalysis at screening as judged by the investigator.
+23 more criteria

Locations (1)

Profil

Neuss, Germany

Key Dates

Start Date

May 27, 2024

Primary Completion Date

July 18, 2025

Completion Date

July 18, 2025

Last Updated

September 23, 2025

Enrollment

ACTUAL participants

Conditions

Type 2 Diabetes

Interventions

NEX-22A, a prolonged release formulation of liraglutide

DRUG

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

View study

RECRUITINGPHASE2

Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)

NCT07296484

Type 2 DiabetesCortisol Excess

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 23, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Feasibility of a Tailored Online Self-compassion Intervention

Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)

iGlarLixi CGM Study in Chinese T2D Individuals After OADs

High Intensity Interval Training and Insulin Sensitivity in Type 2 Diabetes

Closed-loop in Adults With Type 2 Diabetes

SGLT2i, Pioglitazone, and Ketone Production in T2D