Current partner codePEPTIDESDE
NCT06439056·Phase 1·INTERVENTIONAL

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

Status

Completed

Phase

Phase 1

Enrollment

12

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

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 Blood samples for PK analysis will be withdrawn at specified timepoints over a period of 36 days

Interventions

Treatment arms and agents.

DRUG

NEX-22A, a prolonged release formulation of liraglutide

NEX-22A, a prolonged release formulation of liraglutide

Timeline

From registration to results.

  1. First posted

    Jun 3, 2024

  2. Study start

    May 27, 2024

  3. Primary completion

    Jul 18, 2025

  4. Study completion

    Jul 18, 2025

  5. Results posted

    Not reported

  6. Registry updated

    Sep 23, 2025

Outcomes

What the study measures.

Primary outcomes

To evaluate the PK profile of liraglutide after single ascending doses of NEX-22A in subjects with stable type 2 diabetes

Time frame · From administration of study drug until 36 days

Blood samples will be collected in order to calculate a PK profile. Maximum observed plasma concentration (Cmax)

To evaluate the PK profile of liraglutide after single ascending doses of NEX-22A in subjects with stable type 2 diabetes

Time frame · From administration of study drug until 36 days

Blood samples will be collected in order to calculate a PK profile. Time of occurrence of Cmax (Tmax)

To evaluate the PK profile of liraglutide after single ascending doses of NEX-22A in subjects with stable type 2 diabetes

Time frame · From administration of study drug until 36 days

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)

To evaluate the PK profile of liraglutide after single ascending doses of NEX-22A in subjects with stable type 2 diabetes

Time frame · From administration of study drug until 36 days

Blood samples will be collected in order to calculate a PK profile. AUC from time 0 to 12 hours (AUC0-12h)

To evaluate the PK profile of liraglutide after single ascending doses of NEX-22A in subjects with stable type 2 diabetes

Time frame · From administration of study drug until 36 days

Blood samples will be collected in order to calculate a PK profile. AUC from time 0 to 24 hours (AUC0-24h)

To evaluate the PK profile of liraglutide after single ascending doses of NEX-22A in subjects with stable type 2 diabetes

Time frame · From administration of study drug until 36 days

Blood samples will be collected in order to calculate a PK profile. AUC from time 0 to 72 hours (AUC0-72h)

To evaluate the PK profile of liraglutide after single ascending doses of NEX-22A in subjects with stable type 2 diabetes

Time frame · From administration of study drug until 36 days

Blood samples will be collected in order to calculate a PK profile. AUC from time 0 to 7 days (AUC0-7days)

To evaluate the PK profile of liraglutide after single ascending doses of NEX-22A in subjects with stable type 2 diabetes

Time frame · From administration of study drug until 36 days

Blood samples will be collected in order to calculate a PK profile. AUC from 0 to time of last measurable plasma concentration (AUClast)

Secondary outcomes

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

Time frame · From administration of study drug until 36 days

Number of events.Descriptive individual data.

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

Time frame · From administration of study drug until 36 days

Seriousness of adverse events. Descriptive individual data.

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

Time frame · From administration of study drug until 36 days

Intensity of adverse events. Descriptive individual data.

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

Time frame · From administration of study drug until 36 days

Relationship to study treatment. Descriptive individual data.

Number of subjects with a clinical significant change from baseline in the systolic blood pressure at 36 days

Time frame · From administration of study drug until 36 days

Measured in mmHg after 10 minutes supine rest. Descriptive individual data.

Number of subjects with a clinical significant change from baseline in in the diastolic blood pressure at 36 days

Time frame · From administration of study drug until 36 days

Measured in mmHg after 10 minutes supine rest. Descriptive individual data.

Number of subjects with a clinical significant change from baseline in the ECG parameter PQ/PR at 36 days

Time frame · From administration of study drug until 36 days

Measured in ms in supine position after 5 minutes of rest using an ECG machine. Descriptive individual data.

Number of subjects with a clinical significant change from baseline in the ECG parameter QRS at 36 days

Time frame · From administration of study drug until 36 days

Measured in ms in supine position after 5 minutes of rest using an ECG machine. Descriptive individual data.

Number of subjects with a clinical significant change from baseline in the ECG parameter QT at 36 days

Time frame · From administration of study drug until 36 days

Measured in ms in supine position after 5 minutes of rest using an ECG machine. Descriptive individual data.

Number of subjects with a clinical significant change from baseline in the ECG parameter QTcB at 36 days

Time frame · From administration of study drug until 36 days

Measured in ms in supine position after 5 minutes of rest using an ECG machine. Descriptive individual data.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
65 Years
Sex
ALL
Healthy volunteers
No

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. 11. 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). 12. Heart rate at rest (as measured in vital sign assessment at screening) outside the range of 50-90 beats per minute. 13. Clinically significant abnormal standard 12-lead electrocardiogram (ECG) after 5 minutes resting in supine position at screening, as judged by the investigator. 14. Proliferative retinopathy or maculopathy as judged by the investigator based on a recent (\<1.5 years) ophthalmologic examination. 15. Severe neuropathy, in particular autonomic neuropathy, as judged by the investigator. 16. Former or current use of liraglutide or any other GLP-1 receptor agonists (exenatide, semaglutide) except for the use in clinical trials. 17. Current use of any insulin or sulfonylureas. 18. Significant history of alcoholism or drug abuse as judged by the investigator or consuming more than 24.0 grams alcohol/day (for males), 12.0 grams alcohol/day (for females) on average. 19. A positive result in the alcohol and/or urine drug screen at the screening visit. 20. Smoking more than 5 cigarettes or the equivalent per day. 21. Inability or unwillingness to refrain from smoking and use of nicotine substitute products one day before and during the inpatient period. 22. Tested positive for hepatitis Bs antigen. 23. Tested positive for hepatitis C antibodies. (Presence of hepatitis C antibodies will not lead to exclusion if liver function tests are normal and a hepatitis C polymerase chain reaction is negative). 24. Positive result to the test for HIV-1/2 antibodies or HIV-1 antigen. 25. Any medication (prescription and non-prescription drugs) within 14 days before IMP administration and/or anticoagulant therapy. 26. Blood donation or blood loss of more than 500 mL within the last 3 months. 27. Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation. 28. Committed to an institution by virtue of an order issued either by the judicial or the administrative authorities. 29. Women of childbearing potential. 30. Trial site personnel directly affiliated with this trial and their immediate families (spouse, biological or legal guardian, child, or sibling). 31. The investigator considers a subject as unsuitable for inclusion in the trial for any other reason. Explanatory note on Exclusion Criterion 25: Exceptions are stable doses of metformin, SGLT2-blockers, low dose aspirin, antihypertensives, statins, thyroid hormones or occasional use of paracetamol or ibuprofen, and ,if female, with the exception of menopausal hormone replacement therapy. Explanatory note on Exclusion Criterion 29: A woman is considered of childbearing potential following menarche and until becoming postmenopausal unless permanently sterile due to hysterectomy, or bilateral salpingectomy, or bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.

Study locations

1 registered sites.

Germany. Showing up to 24 locations stored in the fast local snapshot.

Profil

Neuss, Germany

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Liraglutide.

Related PeptideStat pages

Put the record in context.

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