NCT06439056

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Nanexa AB · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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 Blood samples for PK analysis will be withdrawn at specified timepoints over a period of 36 days

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	NEX-22A, a prolonged release formulation of liraglutide	NEX-22A, a prolonged release formulation of liraglutide

Timeline

• Start date: 2024-05-27
• Primary completion: 2025-07-18
• Completion: 2025-07-18
• First posted: 2024-06-03
• Last updated: 2025-09-23

Locations

1 site across 1 country: Germany