Type 2 DiabetesPhase 1NCT06439056
Phase 1 Study Assessing the Pharmacokinetics of NEX-22A in Subjects With T2D
A Phase 1 study testing NEX-22A, a prolonged release formulation of liraglutide in people with Type 2 Diabetes, run by Nanexa AB at 1 site in Germany.
Trial summary
The purpose with the study is to assess pharmacokinetics of NEX-22A in patients with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- NEX-22A, a prolonged release formulation of liraglutide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteGermany
- Study dates
- 27 May 2024to 18 Jul 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 33Show fewer
- 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.
- Former or current use of liraglutide or any other GLP-1 receptor agonists (exenatide, semaglutide) except for the use in clinical trials.
- Current use of any insulin or sulfonylureas.
- 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.
- A positive result in the alcohol and/or urine drug screen at the screening visit.
- Smoking more than 5 cigarettes or the equivalent per day.
- Inability or unwillingness to refrain from smoking and use of nicotine substitute products one day before and during the inpatient period.
- Tested positive for hepatitis Bs antigen.
- 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).
- Positive result to the test for HIV-1/2 antibodies or HIV-1 antigen.
- Any medication (prescription and non-prescription drugs) within 14 days before IMP administration and/or anticoagulant therapy.
- Blood donation or blood loss of more than 500 mL within the last 3 months.
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation.
- Committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.
- Women of childbearing potential.
- Trial site personnel directly affiliated with this trial and their immediate families (spouse, biological or legal guardian, child, or sibling).
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
The purpose with the study is to assess pharmacokinetics of NEX-22A in patients with type 2 diabetes.
Read the 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
- Being tested
- NEX-22A, a prolonged release formulation of liraglutide
- Keywords
- Type 2 diabetes, PK study, Long acting injectable, Liraglutid, GLP-1
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NEX-22A, a prolonged release formulation of liraglutideDrug
NEX-22A, a prolonged release formulation of liraglutide
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: NEX-22A, a prolonged release formulation of liraglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: From administration of study drug until 36 days
Secondary outcomes (30)
Number of subjects with treatment-related adverse events a assessed by frequency
Number of events.Descriptive individual data.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From administration of study drug until 36 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study start27 May 2024
- Primary completion18 Jul 2025
- Study completion18 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanexa AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Profil Institut für Stoffwechselforschung GmbH
- Responsible party
- Sponsor
- Investigators
- Grit Andersen, MD, Principal investigator, Profil Institut für Stoffwechselforschung GmbH Hellersbergstr. 9 D-41460 Neuss
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06439056
- Sponsor's protocol ID
- NEX-22-01
- Status last verified
- Sep 2025
- First submitted
- 16 May 2024
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06439056
- Acronym / sponsor ID
- NEX-22-01
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 diabetes, PK study, Long acting injectable, Liraglutid, GLP-1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Nanexa ABIndustry (pharma, biotech, devices)
- Collaborators
- Profil Institut für Stoffwechselforschung GmbH
- Study start
- 27 May 2024 (actual)
- Primary completion
- 18 Jul 2025 (actual)
- Study completion
- 18 Jul 2025 (actual)
- First posted
- 3 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Single dose of NEX-22-01 | Experimental | Drug: NEX-22A, a prolonged release formulation of liraglutideThe trial is single ascending dose study where the dose is escalated depending on previous cohorts PK data. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (33 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NEX-22A, a prolonged release formulation of liraglutideNEX-22A, a prolonged release formulation of liraglutide | Drug | Single dose of NEX-22-01 |
Primary outcome
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)
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 infinity (AUCinf)
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. Terminal elimination half-life (T1/2)
30 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 subjects with treatment-related adverse events a assessed by seriouness
Time frame: From administration of study drug until 36 days
Number of subjects with treatment-related adverse events a assessed by intensity
Time frame: From administration of study drug until 36 days
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
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
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
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
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
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
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
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
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
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
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
Number 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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Type 2 Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Grit Andersen, MD principal investigator
Profil Institut für Stoffwechselforschung GmbH Hellersbergstr. 9 D-41460 Neuss
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NEX-22A, a prolonged release formulation of liraglutide in people with Type 2 Diabetes, run by Nanexa AB at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025.