Diabetes Mellitus, Type 2Phase 1NCT05015894
A Research Study Looking Into Blood Levels of the Medicine NNC0480-0389 in Participants With Reduced Kidney Function Compared to Participants With Normal Kidney Function
A Phase 1 study testing NNC0480-0389 in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Germany.
Trial summary
Novo Nordisk is developing a combination therapy with the study medicine NNC0480-0389 and an already approved medicine called "semaglutide" for the treatment of type-2 diabetes (T2D). Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- NNC0480-0389
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteGermany
- Study dates
- 30 Aug 2021to 2 Aug 2022
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female of non-childbearing potential, aged 18-75 years (both inclusive) at the time of signing informed consent.
- Body mass index (BMI) between 20.0 and 39.9 kg/m^2 (both inclusive)
- Meeting the pre-defined GFR criteria using estimated GFR (eGFR) based on serum creatinine for any of the renal function groups:
- For participants with normal renal function: eGFR of equal to or greater than 90 mL/min
- For participants with mild renal impairment: eGFR of 60-89 mL/min
- For participants with moderate renal impairment: eGFR of 30-59 mL/min
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- For participants with severe renal impairment: eGFR of 15-29 mL/min not requiring dialysis
- For participants with kidney failure: eGFR of less than 15 mL/min or requiring dialysis treatment
- Specific inclusion criteria for participants with kidney failure requiring dialysis treatment:
- Current treatment with haemodialysis
Who cannot join
- Any disorder which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- Use of prescription medicinal products or non-prescription drugs, or non-routine vitamins, which at the investigators judgement may affect participant safety or the results of the study within 14 days before screening.
- Use of drugs known to affect creatinine clearance including cephalosporin and aminoglycoside antibiotics, flucytosine, cisplatin, cimetidine, trimethoprim and cibenzoline within 14 days or 5 half-lives, whichever is greater, before dosing the investigational medicinal product (IMP).
- Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions (except conditions associated with renal impairment or kidney failure).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Pharmacokinetics of Subcutaneously Administered NNC0480-0389 in Participants With Various Degrees of Impaired Renal Function Compared to Participants With Normal Renal Function
Novo Nordisk is developing a combination therapy with the study medicine NNC0480-0389 and an already approved medicine called "semaglutide" for the treatment of type-2 diabetes (T2D). It is expected that the combination will further improve the blood sugar control compared to semaglutide therapy alone.In this study the blood levels of NNC0480-0389 will be compared in people with various degrees of reduced kidney function to the blood levels in people with normal kidney function, after administration of one dose of 18 mg NNC0480-0389. Participants will only get the study medicine as two injections into a skinfold of participants belly (subcutaneous).
The study will last for about 65 days including a screening phase of up to 28 days prior to dosing.
Read more
If participants are eligible for the study, participants will have 11 visits to the study centre including one in-house stay of 5 days and 4 nights (Visit 2) and nine ambulatory visits (Visit 3 to Visit 11).
Participants' vital signs (heart rate, blood pressure, body temperature) will be measured, participants will have blood drawn, urine will be collected and electrocardiograms (ECGs) will be recorded.If participants are women and can get pregnant they cannot take part in the study. A hormone test will be done to check if participants may be post-menopausal.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- NNC0480-0389
- 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.
NNC0480-0389Drug
A single dose of 18 mg NNC0480 0389 administered subcutaneously (under the skin).
Total duration of study participation for each participant is 38 to 66 days
| Study group | Role | What they receive |
|---|---|---|
| NNC0480-0389 | Experimental | All participants will be administered a single s.c. dose of 18 mg NNC0480-0389 Receives: Drug: NNC0480-0389 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-∞,NNC0480-0389,SD, area under the NNC0480-0389 plasma concentration time curve after a single dose
h*nmol/L
Measured: From baseline (visit 2, day 1, pre-dose) until completion of the end-of-study visit (visit 11, day 36)
Secondary outcomes (1)
Cmax,NNC0480-0389,SD, Maximum observed NNC0480-0389 plasma concentration after a single dose
nmol/L
Measured: From baseline (visit 2, day 1, pre-dose) until completion of the end-of-study visit (visit 11, day 36)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2021
- Study start30 Aug 2021
- Primary completion2 Aug 2022
- Study completion2 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (Dept. 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05015894
- Sponsor's protocol ID
- NN9389-4682
- Other IDs
- 2021-001450-57, U1111-1266-0594
- Status last verified
- Nov 2023
- First submitted
- 19 Aug 2021
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Pharmacokinetics of Subcutaneously Administered NNC0480-0389 in Participants With Various Degrees of Impaired Renal Function Compared to Participants With Normal Renal Function
- ClinicalTrials.gov ID
- NCT05015894
- Acronym / sponsor ID
- NN9389-4682
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 30 Aug 2021 (actual)
- Primary completion
- 2 Aug 2022 (actual)
- Study completion
- 2 Aug 2022 (actual)
- First posted
- 23 Aug 2021 (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.
Novo Nordisk is developing a combination therapy with the study medicine NNC0480-0389 and an already approved medicine called "semaglutide" for the treatment of type-2 diabetes (T2D). It is expected that the combination will further improve the blood sugar control compared to semaglutide therapy alone.In this study the blood levels of NNC0480-0389 will be compared in people with various degrees of reduced kidney function to the blood levels in people with normal kidney function, after administration of one dose of 18 mg NNC0480-0389. Participants will only get the study medicine as two injections into a skinfold of participants belly (subcutaneous).
The study will last for about 65 days including a screening phase of up to 28 days prior to dosing.
If participants are eligible for the study, participants will have 11 visits to the study centre including one in-house stay of 5 days and 4 nights (Visit 2) and nine ambulatory visits (Visit 3 to Visit 11).
Participants' vital signs (heart rate, blood pressure, body temperature) will be measured, participants will have blood drawn, urine will be collected and electrocardiograms (ECGs) will be recorded.If participants are women and can get pregnant they cannot take part in the study. A hormone test will be done to check if participants may be post-menopausal.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NNC0480-0389 | Experimental | Drug: NNC0480-0389All participants will be administered a single s.c. dose of 18 mg NNC0480-0389 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female of non-childbearing potential, aged 18-75 years (both inclusive) at the time of signing informed consent.
- Body mass index (BMI) between 20.0 and 39.9 kg/m^2 (both inclusive)
- Meeting the pre-defined GFR criteria using estimated GFR (eGFR) based on serum creatinine for any of the renal function groups:
- Specific inclusion criteria for participants with kidney failure requiring dialysis treatment:
- Current treatment with haemodialysis
Key exclusion criteria (4 listed)
- Any disorder which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- Use of prescription medicinal products or non-prescription drugs, or non-routine vitamins, which at the investigators judgement may affect participant safety or the results of the study within 14 days before screening.
- Use of drugs known to affect creatinine clearance including cephalosporin and aminoglycoside antibiotics, flucytosine, cisplatin, cimetidine, trimethoprim and cibenzoline within 14 days or 5 half-lives, whichever is greater, before dosing the investigational medicinal product (IMP).
- Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions (except conditions associated with renal impairment or kidney failure).
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 |
|---|---|---|
| NNC0480-0389A single dose of 18 mg NNC0480 0389 administered subcutaneously (under the skin). Total duration of study participation for each participant is 38 to 66 days | Drug | NNC0480-0389 |
Primary outcome
AUC0-∞,NNC0480-0389,SD, area under the NNC0480-0389 plasma concentration time curve after a single dose
Time frame: From baseline (visit 2, day 1, pre-dose) until completion of the end-of-study visit (visit 11, day 36)
h*nmol/L
1 secondary outcome
Cmax,NNC0480-0389,SD, Maximum observed NNC0480-0389 plasma concentration after a single dose
Time frame: From baseline (visit 2, day 1, pre-dose) until completion of the end-of-study visit (visit 11, day 36)
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 13 Nov 2023.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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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.
Clinical Transparency (Dept. 1452) study director
Novo Nordisk A/S
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 NNC0480-0389 in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S 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 10 inclusion and 4 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 13 Nov 2023. 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?
AUC0-∞,NNC0480-0389,SD, area under the NNC0480-0389 plasma concentration time curve after a single dose (time frame: From baseline (visit 2, day 1, pre-dose) until completion of the end-of-study visit (visit 11, day 36)). 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 13 Nov 2023.