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Clinical Trial Details

Trial ID: L6234
Source ID: NCT06439056
Associated Drug: Nex-22a, A Prolonged Release Formulation Of Liraglutide
Title: Phase 1 Study Assessing the Pharmacokinetics of NEX-22A in Subjects With T2D
Acronym:
Status: RECRUITING
Study Results: NO
Results:
Conditions: Type 2 Diabetes
Interventions: DRUG: NEX-22A, a prolonged release formulation of liraglutide
Outcome Measures: Primary: To evaluate the PK profile of liraglutide after single ascending doses of NEX-22A in subjects with stable type 2 diabetes, Blood samples will be collected in order to calculate a PK profile. Maximum observed plasma concentration (Cmax), From administration of study drug until 36 days|To evaluate the PK profile of liraglutide after single ascending doses of NEX-22A in subjects with stable type 2 diabetes, Blood samples will be collected in order to calculate a PK profile. Time of occurrence of Cmax (Tmax), From administration of study drug until 36 days|To evaluate the PK profile of liraglutide after single ascending doses of NEX-22A in subjects with stable type 2 diabetes, Blood samples will be collected in order to calculate a PK profile. occurrence of Area under the plasma concentration vs. time curve (AUC) from time 0 to 8 hours (AUC0-8h), From administration of study drug until 36 days|To evaluate the PK profile of liraglutide after single ascending doses of NEX-22A in subjects with stable type 2 diabetes, Blood samples will be collected in order to calculate a PK profile. AUC from time 0 to 12 hours (AUC0-12h), From administration of study drug until 36 days|To evaluate the PK profile of liraglutide after single ascending doses of NEX-22A in subjects with stable type 2 diabetes, Blood samples will be collected in order to calculate a PK profile. AUC from time 0 to 24 hours (AUC0-24h), From administration of study drug until 36 days|To evaluate the PK profile of liraglutide after single ascending doses of NEX-22A in subjects with stable type 2 diabetes, Blood samples will be collected in order to calculate a PK profile. AUC from time 0 to 72 hours (AUC0-72h), From administration of study drug until 36 days|To evaluate the PK profile of liraglutide after single ascending doses of NEX-22A in subjects with stable type 2 diabetes, Blood samples will be collected in order to calculate a PK profile. AUC from time 0 to 7 days (AUC0-7days), From administration of study drug until 36 days|To evaluate the PK profile of liraglutide after single ascending doses of NEX-22A in subjects with stable type 2 diabetes, Blood samples will be collected in order to calculate a PK profile. AUC from 0 to time of last measurable plasma concentration (AUClast), From administration of study drug until 36 days|To evaluate the PK profile of liraglutide after single ascending doses of NEX-22A in subjects with stable type 2 diabetes, Blood samples will be collected in order to calculate a PK profile. AUC from time 0 to infinity (AUCinf), From administration of study drug until 36 days|To evaluate the PK profile of liraglutide after single ascending doses of NEX-22A in subjects with stable type 2 diabetes, Blood samples will be collected in order to calculate a PK profile. Terminal elimination half-life (T1/2), From administration of study drug until 36 days | Secondary: Number of subjects with treatment-related adverse events a assessed by frequency, Number of events.Descriptive individual data., From administration of study drug until 36 days|Number of subjects with treatment-related adverse events a assessed by seriouness, Seriousness of adverse events. Descriptive individual data., From administration of study drug until 36 days|Number of subjects with treatment-related adverse events a assessed by intensity, Intensity of adverse events. Descriptive individual data., From administration of study drug until 36 days|Number of subjects with treatment-related adverse events a assessed by relationship to study treatment, Relationship to study treatment. Descriptive individual data., From administration of study drug until 36 days|Number of subjects with a clinical significant change from baseline in the systolic blood pressure at 36 days, Measured in mmHg after 10 minutes supine rest. Descriptive individual data., From administration of study drug until 36 days|Number of subjects with a clinical significant change from baseline in in the diastolic blood pressure at 36 days, Measured in mmHg after 10 minutes supine rest. Descriptive individual data., From administration of study drug until 36 days|Number of subjects with a clinical significant change from baseline in the ECG parameter PQ/PR at 36 days, Measured in ms in supine position after 5 minutes of rest using an ECG machine. Descriptive individual data., From administration of study drug until 36 days|Number of subjects with a clinical significant change from baseline in the ECG parameter QRS at 36 days, Measured in ms in supine position after 5 minutes of rest using an ECG machine. Descriptive individual data., From administration of study drug until 36 days|Number of subjects with a clinical significant change from baseline in the ECG parameter QT at 36 days, Measured in ms in supine position after 5 minutes of rest using an ECG machine. Descriptive individual data., From administration of study drug until 36 days|Number of subjects with a clinical significant change from baseline in the ECG parameter QTcB at 36 days, Measured in ms in supine position after 5 minutes of rest using an ECG machine. Descriptive individual data., From administration of study drug until 36 days|Number of subjects with a clinical significant change from baseline in the ECG parameter heart rate at 36 days, Measured in ms in supine position after 5 minutes of rest using an ECG machine. Descriptive individual data., From administration of study drug until 36 days|Number of subjects with a clinical significant change from baseline in the haematology blood parameters measurements at 36 days, Blood samples for the analysis of haematology parameters will be collected through venepuncture or an indwelling venous catheter. Descriptive individual data., From administration of study drug until 36 days|Number of subjects with a clinical significant change from baseline in the clinical chemistry blood laboratory measurements at 36 days, Blood samples for the analysis of clinical chemistry parameters will be collected through venepuncture or an indwelling venous catheter. Descriptive individual data., From administration of study drug until 36 days|Number of subjects with a clinical significant change from baseline in the coagulation blood laboratory measurements at 36 days, Blood samples for the analysis of coagulation parameters will be collected through venepuncture or an indwelling venous catheter. Descriptive individual data., From administration of study drug until 36 days|Number of subjects with a clinical significant change from baseline in plasma glucose measurement at 36 days, Blood samples for the analysis of plasma glucos will be collected through venepuncture or an indwelling venous catheter. Descriptive individual data., From administration of study drug until 36 days|Number of subjects with a clinical significant change from baseline in the physical examination of the head at 36 days, Physical examination including assessment of the head. Descriptive individual data., From administration of study drug until 36 days|Number of subjects with a clinical significant change from baseline in the physical examination of the eyes at 36 days, Physical examination including assessment of the eyes. Descriptive individual data., From administration of study drug until 36 days|Number of subjects with a clinical significant change from baseline in the physical examination of the ears at 36 days, Physical examination including assessment of the ears. Descriptive individual data., From administration of study drug until 36 days|Number of subjects with a clinical significant change from baseline in the physical examination of the nose at 36 days, Physical examination including assessment of the nose. Descriptive individual data., From administration of study drug until 36 days|Number of subjects with a clinical significant change from baseline in the physical examination of the throat at 36 days, Physical examination including assessment of the throat. Descriptive individual data., From administration of study drug until 36 days|Number of subjects with a clinical significant change from baseline in the physical examination of the skin and mucosae at 36 days, Physical examination including assessment of the skin and mucosae. Descriptive individual data., From administration of study drug until 36 days|Number of subjects with a clinical significant change from baseline in the physical examination of the tyroid at 36 days, Physical examination including assessment of the tyroid. Descriptive individual data., From administration of study drug until 36 days|Number of subjects with a clinical significant change from baseline in the physical examination of the neurological status at 36 days, Physical examination including assessment of the neurological status. Descriptive individual data., From administration of study drug until 36 days|Number of subjects with a clinical significant change from baseline in the physical examination of the lungs at 36 days, Physical examination including assessment of the lungs. Descriptive individual data., From administration of study drug until 36 days|Number of subjects with a clinical significant change from baseline in the physical examination of the cardiovascular system at 36 days, Physical examination including assessment of the cardiovascular system including inspection, palpation, and auscultation.Descriptive individual data., From administration of study drug until 36 days|Number of subjects with a clinical significant change from baseline in the physical examination of the gastrointestinal system incl mouth at 36 days, Physical examination including palpation of the gastrointestinal system incl mouth check. Descriptive individual data., From administration of study drug until 36 days|Number of subjects with a clinical significant change from baseline in the physical examination of the lymfh nodes incl mouth at 36 days, Physical examination including palpation of the lymfh nodes. Descriptive individual data., From administration of study drug until 36 days|Number of subjects with a clinical significant change from baseline in the musculoskeletal system at 36 days., Physical examination of the musculoskeletal system. Descriptive individual data., From administration of study drug until 36 days|Number of subjects with a clinical significant change from baseline in local tolerability i.e skin reactions assessed by visual inspection., Visual inspection. Descriptive individual data., From administration of study drug until 36 days|Number of subjects with a clinical significant change from baseline in local tolerability i.e skin reactions assessed by photography., Photography of injection site Descriptive individual data., From administration of study drug until 36 days
Sponsor/Collaborators: Sponsor: Nanexa AB | Collaborators: Profil Institut für Stoffwechselforschung GmbH
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 12
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-05-27
Completion Date: 2025-05
Results First Posted:
Last Update Posted: 2025-03-06
Locations: Profil, Neuss, 41460, Germany
URL: https://clinicaltrials.gov/show/NCT06439056