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
Lead sponsor
Asset
Liraglutide
Subcutaneous · GLP-1 agonist
Listed sites
1
Recruiting sites
-
Actual enrollment
12
Study population
Type 2 diabetes
Eligibility highlights
•BMI 18.5-35
Primary endpoint
•PK profile of liraglutide after single ascending doses of NEX-22A
Registered trial locations
Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Who this study enrolls
Who can enroll
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.
Endpoints (40)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Glycemic / diabetes
1 endpointNumber of subjects with a clinical significant change from baseline in plasma glucose measurement at 36 days
Time frame:From administration of study drug until 36 days
threshold achievement, improvement
Cardiometabolic biomarkers
3 endpointsNumber 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
Systolic BP, change
threshold achievement, improvement
LOINC 8480-6
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
Diastolic BP, change
threshold achievement, improvement
LOINC 8462-4
Number of subjects with a clinical significant change from baseline in the ECG parameter heart rate at 36 days
Time frame:From administration of study drug until 36 days
Heart rate, change
threshold achievement, improvement
Safety / tolerability / PK
36 endpointsTo 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
Cmax
concentration, descriptive
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
Tmax
descriptive
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
AUC₀-∞
concentration, descriptive
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
concentration, descriptive
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
concentration, descriptive
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
concentration, descriptive
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
concentration, descriptive
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
concentration, descriptive
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
AUC₀-∞
concentration, descriptive
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
Half-life
descriptive
Number of subjects with treatment-related adverse events a assessed by frequency
Time frame:From administration of study drug until 36 days
Treatment-emergent AEs (any)
event count, event
Number of subjects with treatment-related adverse events a assessed by seriouness
Time frame:From administration of study drug until 36 days
Serious AEs (any)
event count, event
Number of subjects with treatment-related adverse events a assessed by intensity
Time frame:From administration of study drug until 36 days
Treatment-emergent AEs (any)
descriptive
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
Treatment-emergent AEs (any)
event count, event
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
threshold achievement, event
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
threshold achievement, event
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
threshold achievement, event
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
threshold achievement, event
Number of subjects with a clinical significant change from baseline in the haematology blood parameters measurements at 36 days
Time frame:From administration of study drug until 36 days
threshold achievement, event
Number of subjects with a clinical significant change from baseline in the clinical chemistry blood laboratory measurements at 36 days
Time frame:From administration of study drug until 36 days
threshold achievement, event
Number of subjects with a clinical significant change from baseline in the coagulation blood laboratory measurements at 36 days
Time frame:From administration of study drug until 36 days
threshold achievement, event
Number of subjects with a clinical significant change from baseline in the physical examination of the head at 36 days
Time frame:From administration of study drug until 36 days
descriptive
Number of subjects with a clinical significant change from baseline in the physical examination of the eyes at 36 days
Time frame:From administration of study drug until 36 days
descriptive
Number of subjects with a clinical significant change from baseline in the physical examination of the ears at 36 days
Time frame:From administration of study drug until 36 days
descriptive
Number of subjects with a clinical significant change from baseline in the physical examination of the nose at 36 days
Time frame:From administration of study drug until 36 days
descriptive
Number of subjects with a clinical significant change from baseline in the physical examination of the throat at 36 days
Time frame:From administration of study drug until 36 days
descriptive
Number of subjects with a clinical significant change from baseline in the physical examination of the skin and mucosae at 36 days
Time frame:From administration of study drug until 36 days
descriptive
Number of subjects with a clinical significant change from baseline in the physical examination of the tyroid at 36 days
Time frame:From administration of study drug until 36 days
Thyroid event
descriptive, event
Number of subjects with a clinical significant change from baseline in the physical examination of the neurological status at 36 days
Time frame:From administration of study drug until 36 days
descriptive
Number of subjects with a clinical significant change from baseline in the physical examination of the lungs at 36 days
Time frame:From administration of study drug until 36 days
descriptive
Number of subjects with a clinical significant change from baseline in the physical examination of the cardiovascular system at 36 days
Time frame:From administration of study drug until 36 days
descriptive
Number of subjects with a clinical significant change from baseline in the physical examination of the gastrointestinal system incl mouth at 36 days
Time frame:From administration of study drug until 36 days
descriptive
Number of subjects with a clinical significant change from baseline in the physical examination of the lymfh nodes incl mouth at 36 days
Time frame:From administration of study drug until 36 days
descriptive
Number of subjects with a clinical significant change from baseline in the musculoskeletal system at 36 days.
Time frame:From administration of study drug until 36 days
descriptive
Number of subjects with a clinical significant change from baseline in local tolerability i.e skin reactions assessed by visual inspection.
Time frame:From administration of study drug until 36 days
threshold achievement, event
Number of subjects with a clinical significant change from baseline in local tolerability i.e skin reactions assessed by photography.
Time frame:From administration of study drug until 36 days
descriptive
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.