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

NCT06439056 | Completed Phase 1

• 1 other identifier: NEX-22-01
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Type 2 Diabetes

Keywords

Type 2 diabetes; PK study; Long acting injectable; Liraglutid; GLP-1

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (30)

• Number of subjects with treatment-related adverse events a assessed by frequency

  From administration of study drug until 36 days

• Number of subjects with treatment-related adverse events a assessed by seriouness

  From administration of study drug until 36 days

• Number of subjects with treatment-related adverse events a assessed by intensity

  From administration of study drug until 36 days

• Number of subjects with treatment-related adverse events a assessed by relationship to study treatment

  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

  From administration of study drug until 36 days

Study Arms (1)

Single dose of NEX-22-01

EXPERIMENTAL

The trial is single ascending dose study where the dose is escalated depending on previous cohorts PK data.

Drug: NEX-22A, a prolonged release formulation of liraglutide

Interventions

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

NEX-22A, a prolonged release formulation of liraglutide

Single dose of NEX-22-01

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• 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.
• History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.
• Any history or presence of cancer except basal cell skin cancer or squamous cell skin cancer as judged by the investigator.
• Clinically relevant comorbidity, capable of constituting a risk for the subject when participating in the trial or of interfering with the interpretation of data.
• Signs of acute illness as judged by the investigator.
• Any serious systemic infectious disease during four weeks prior to first dosing of the trial drug, as judged by the investigator.
• Subjects with dermatological conditions, tattoos or large scars on the abdomen that would limit the evaluation of local tolerability, as judged by the investigator.
• Clinically significant abnormal values for haematology, biochemistry, coagulation, or urinalysis at screening as judged by the investigator.
• Systolic blood pressure \< 90 mmHg or \>160 mmHg and/or diastolic blood pressure \< 50 mmHg or \> 95 mmHg at screening (one repeat test will be acceptable in case of suspected white-coat hypertension).
• Heart rate at rest (as measured in vital sign assessment at screening) outside the range of 50-90 beats per minute.
• Clinically significant abnormal standard 12-lead electrocardiogram (ECG) after 5 minutes resting in supine position at screening, as judged by the investigator.
• Proliferative retinopathy or maculopathy as judged by the investigator based on a recent (\<1.5 years) ophthalmologic examination.
• Severe neuropathy, in particular autonomic neuropathy, as judged by the investigator.

Sponsors & Collaborators

• Nanexa AB: lead
• Profil Institut für Stoffwechselforschung GmbH: collaborator

Study Sites (1)

Profil

Neuss, 41460, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Grit Andersen, MD

  Profil Institut für Stoffwechselforschung GmbH Hellersbergstr. 9 D-41460 Neuss

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single ascending dose study including 3 cohorts (3 patients/cohort). The subjects will be enrolled in the respective cohorts, starting with cohort 1. NEX-22A will be administered in a sentinel fashion within the cohorts. A single participant will be dosed first in every cohort. If there are no safety concerns as judged by the investigator, the remaining subjects will be dosed at least 10 days after the sentinel.

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: June 3, 2024
• Study Start: May 27, 2024
• Primary Completion: July 18, 2025
• Study Completion: July 18, 2025
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)