Diabetes Mellitus, Type 2Phase 1NCT06559527

A Research Study Looking Into Blood Levels of the Medicine NNC0487-0111 in the Body and How Well it is Tolerated in Participants With Reduced Kidney Function and Normal Kidney Function

A Phase 1 study testing NNC0487-0111 in people with Diabetes Mellitus, Type 2 and Obesity, run by Novo Nordisk A/S at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Novo Nordisk is developing the study medicine NNC0487-0111 to treat people living with type 2 diabetes and/or people living with overweight or obesity. The aim of this study is to see if blood levels of NNC0487-0111 are the same in people living with various degrees of reduced kidney function as for people with normal… Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Diabetes Mellitus, Type 2, Obesity, Overweight
What is being tested?: NNC0487-0111
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: 20 Aug 2024to 5 Mar 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 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female, aged 18-80 years (both inclusive) at the time of signing the informed consent
Body mass index (BMI) between 20.0 and 39.9 kilogram per square meter (kg/m^2) (both inclusive) at screening.
Meeting the pre-defined eGFR values based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation (2021) adjusted for the estimated individual body surface area (BSA);
Normal renal function - greater than or equal to 90 mL/min
Mild renal impairment - 60 - 89 (mL/min)
Moderate renal impairment - 30 - 59 (mL/min)

Show all 9Show fewer

Severe renal impairment - less than 30 (mL/min) not requiring dialysis
End-stage renal disease (ESRD) - Requiring dialysis treatment
For ESRD: Participants requiring dialysis treatment should be on current treatment with haemodialysis.

Who cannot join

Any disorder, unwillingness, or inability which in the investigator's opinion might jeopardize participant's safety or compliance with the protocol.
Use of drugs known to affect creatinine clearance including cephalosporin and aminoglycoside, antibiotics, flucytosine, cisplatin, cimetidine, trimethoprim, cibenzoline, and nitrofurantoin 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, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions(except conditions associated with renal impairment or ESRD).

Trial locations and contacts

1 site in 1 country.

Germany1 site

Charité Research Organisation GmbH
Berlin, 10117

Other trials in Germany

About this study

Official title: Investigation of Pharmacokinetics, Safety and Tolerability of a Single Subcutaneous Dose of NNC0487-0111 in Participants With Various Degrees of Renal Impairment and Normal Renal Function

Conditions: Diabetes Mellitus, Type 2, Obesity, Overweight
Being tested: NNC0487-0111
Medical subject headings: Diabetes Mellitus, Type 2, Obesity, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NNC0487-0111Drug
Participants will administer a single dose of NNC0487-0111 subcutaneously using NovoPen®4 by injection into a skinfold on the abdomen.

Study groups in NCT06559527
Study group	Role	What they receive
Mild Renal Impairment	Experimental	Participants with mild renal impairment (estimated glomerular filtration rate [eGFR] - 60 - 89 milliliter per min [mL/min]) will administer a single dose of NNC0487-0111 on Day 1. Receives: Drug: NNC0487-0111
Moderate Renal Impairment	Experimental	Participants with moderate renal impairment (eGFR - 30 - 59 mL/min) will administer a single dose of NNC0487-0111 on Day 1. Receives: Drug: NNC0487-0111
Severe Renal Impairment	Experimental	Participants with severe renal impairment (eGFR - less than 30 mL/min not requiring dialysis) will administer a single dose of NNC0487-0111 on Day 1. Receives: Drug: NNC0487-0111
End-Stage Renal Disease (ESRD)	Experimental	Participants with ESRD (requiring dialysis treatment) will administer a single dose of NNC0487-0111 on Day 1. Receives: Drug: NNC0487-0111
Normal Renal Function	Experimental	Participants with normal renal function (eGFR - greater than or equals 90) will administer a single dose of NNC0487-0111 on Day 1. Receives: Drug: NNC0487-0111

What is being measured

The primary outcome is the main question the study is designed to answer.

AUC0111,0-∞,SD: Area under the NNC0487-0111 plasma concentration-time curve from time 0 to infinity after a single dose
Measured as hours*nanomole per liter (h*nmol/L).
Measured: From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 28)

Secondary outcomes (6)

Cmax,0111,SD: Maximum observed plasma NNC0487-0111concentration after a single dose
Measured as nanomole per liter (nmol/L).
Measured: From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 28)
tmax,0111,SD: Time to maximum observed plasma NNC0487-0111 concentration after a single dose
Measured as hours.
Measured: From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 28)
t½,0111,SD: Terminal half-life of NNC0487-0111 after a single dose
Measured as hours.
Measured: From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 28)
Vz/F0111,SD: Apparent volume of distribution of NNC0487-0111 after a single dose
Measured as liter (L)
Measured: From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 28)
CL/F0111,SD: Apparent clearance of NNC0487-0111 after a single dose
Measured as liter per hour (L/h).
Measured: From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 28)
Number of treatment emergent adverse events (TEAEs)
Measured as number of events.
Measured: From time of trial product administration (Visit 2, Day 1) until completion of the end of study visit (Visit 9, Day 28)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Aug 20245 Mar 2025

First posted19 Aug 2024
Study start20 Aug 2024
Primary completion24 Feb 2025
Study completion5 Mar 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06559527
Sponsor's protocol ID: NN9490-7611
Other IDs: U1111-1298-6886, 2023-509961-19, 2023
Status last verified: Mar 2025
First submitted: 15 Aug 2024
Last updated: 30 Mar 2025
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

Publications

Oldenburg LIK, Haugaard SP, Karlsson T, Kegel-Hubner V, Parwez M, Wiingaard C, Flint A. Renal Impairment Does Not Affect Pharmacokinetics, Safety or Tolerability of Zenagamtide. Diabetes Obes Metab. 2026 Jul 13. doi: 10.1111/dom.71096. Online ahead of print.
PubMed 42443140

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Investigation of Pharmacokinetics, Safety and Tolerability of a Single Subcutaneous Dose of NNC0487-0111 in Participants With Various Degrees of Renal Impairment and Normal Renal Function
ClinicalTrials.gov ID: NCT06559527
Acronym / sponsor ID: NN9490-7611
Conditions: Diabetes Mellitus, Type 2, Obesity, Overweight
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 42 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: 20 Aug 2024 (actual)
Primary completion: 24 Feb 2025 (actual)
Study completion: 5 Mar 2025 (actual)
First posted: 19 Aug 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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
Mild Renal Impairment	Experimental	Drug: NNC0487-0111Participants with mild renal impairment (estimated glomerular filtration rate [eGFR] - 60 - 89 milliliter per min [mL/min]) will administer a single dose of NNC0487-0111 on Day 1.
Moderate Renal Impairment	Experimental	Drug: NNC0487-0111Participants with moderate renal impairment (eGFR - 30 - 59 mL/min) will administer a single dose of NNC0487-0111 on Day 1.
Severe Renal Impairment	Experimental	Drug: NNC0487-0111Participants with severe renal impairment (eGFR - less than 30 mL/min not requiring dialysis) will administer a single dose of NNC0487-0111 on Day 1.
End-Stage Renal Disease (ESRD)	Experimental	Drug: NNC0487-0111Participants with ESRD (requiring dialysis treatment) will administer a single dose of NNC0487-0111 on Day 1.
Normal Renal Function	Experimental	Drug: NNC0487-0111Participants with normal renal function (eGFR - greater than or equals 90) will administer a single dose of NNC0487-0111 on Day 1.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Male or female, aged 18-80 years (both inclusive) at the time of signing the informed consent
Body mass index (BMI) between 20.0 and 39.9 kilogram per square meter (kg/m^2) (both inclusive) at screening.
Meeting the pre-defined eGFR values based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation (2021) adjusted for the estimated individual body surface area (BSA);
For ESRD: Participants requiring dialysis treatment should be on current treatment with haemodialysis.

Key exclusion criteria (3 listed)

Any disorder, unwillingness, or inability which in the investigator's opinion might jeopardize participant's safety or compliance with the protocol.
Use of drugs known to affect creatinine clearance including cephalosporin and aminoglycoside, antibiotics, flucytosine, cisplatin, cimetidine, trimethoprim, cibenzoline, and nitrofurantoin 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, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions(except conditions associated with renal impairment or ESRD).

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
NNC0487-0111Participants will administer a single dose of NNC0487-0111 subcutaneously using NovoPen®4 by injection into a skinfold on the abdomen.	Drug	End-Stage Renal Disease (ESRD), Mild Renal Impairment, Moderate Renal Impairment, Normal Renal Function, Severe Renal Impairment

Primary outcome

AUC0111,0-∞,SD: Area under the NNC0487-0111 plasma concentration-time curve from time 0 to infinity after a single dose
Time frame: From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 28)
Measured as hours*nanomole per liter (h*nmol/L).

6 secondary outcomes

Cmax,0111,SD: Maximum observed plasma NNC0487-0111concentration after a single dose
Time frame: From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 28)
tmax,0111,SD: Time to maximum observed plasma NNC0487-0111 concentration after a single dose
Time frame: From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 28)
t½,0111,SD: Terminal half-life of NNC0487-0111 after a single dose
Time frame: From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 28)
Vz/F0111,SD: Apparent volume of distribution of NNC0487-0111 after a single dose
Time frame: From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 28)
CL/F0111,SD: Apparent clearance of NNC0487-0111 after a single dose
Time frame: From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 28)
Number of treatment emergent adverse events (TEAEs)
Time frame: From time of trial product administration (Visit 2, Day 1) until completion of the end of study visit (Visit 9, Day 28)

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 30 Mar 2025.
Derived from this study: PubMed 42443140Oldenburg LIK, Haugaard SP, Karlsson T, Kegel-Hubner V, Parwez M, Wiingaard C, Flint A. Renal Impairment Does Not Affect Pharmacokinetics, Safety or Tolerability of Zenagamtide. Diabetes Obes Metab. 2026 Jul 13. doi: 10.1111/dom.71096. Online ahead of print.
Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Related trials for Diabetes Mellitus, Type 2

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Recruiting
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Not yet recruitingPhase 3
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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. 2834) 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 NNC0487-0111 in people with Diabetes Mellitus, Type 2 and Obesity, 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 9 inclusion and 3 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 30 Mar 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?

AUC0111,0-∞,SD: Area under the NNC0487-0111 plasma concentration-time curve from time 0 to infinity after a single dose (time frame: From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 28)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06559527, which also lists 1 linked publication.

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 30 Mar 2025.