Diabetes MellitusPhase 1NCT07535307
Investigating How NNC0487-0111 Regulates Insulin of Adults With Type 2 Diabetes
A Phase 1 study testing NNC0487-0111 in people with Diabetes Mellitus, run by Novo Nordisk A/S at 1 site in Germany.
Trial summary
The purpose of this clinical study is to find out how NNC0487-0111 affects, how the body uses insulin (a hormone that helps the body control blood sugar) and how well the pancreas works in people living with type 2 diabetes. There are 2 study treatments. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- NNC0487-0111
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- 10 Apr 2026to 6 Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female.
- Age 18-75 years (both inclusive) at the time of signing the informed consent.
- Diagnosed with type 2 diabetes more than or equal to (≥)180 days before screening.
- Only stable daily dose(s) of metformin at effective or maximum tolerated dose, as judged by the investigator for at least 90 days before screening. If additional oral antidiabetic drug (OAD) is required, only stable dose(s) of sodium-glucose cotransporter-2 inhibitors (SGLT2i) is permitted, and this must also have been maintained for at least 90 days before screening.
- HbA1c at screening of 6.5-9.5% [48-80 millimole per mole (mmol/mol)] (both inclusive) if on metformin only, or 6.0-9.0% (42-75 mmol/mol) (both inclusive) if on metformin in combination with SGLT2i.
Who cannot join
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive method.
- Presence of type 1 diabetes.
- Any clinically significant body weight change (≥5% self-reported change) or dieting attempts (e.g., participation in a weight reduction program) within 90 days before screening.
- Treatment with any medication for the indication of T2D or weight management other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days and prior insulin treatment for gestational diabetes are allowed.
- Treatment with a GLP-1 receptor agonist.
- Participant with diabetic retinopathy or maculopathy who received treatment with retinal photocoagulation, vitrectomy or anti-Vascular Endothelial Growth Factor (anti-VEGF) before screening or are expected to require treatment after screening. Diabetic retinopathy or maculopathy must be verified by an eye examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
- Presence or history of cardiovascular disease including stable and unstable angina pectoris, myocardial infarction, transient ischaemic attack, stroke, cardiac decompensation, clinically significant arrhythmias or clinically significant conduction disorders within 180 days before screening.
- Renal impairment with estimated glomerular filtration rate (eGFR) less than (<) 60.0 milliliter per minute per meter square (ml/min/1.73 m^2) at screening.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Profil Institut für Stoffwechselforschung GmbH
Neuss, 41460
About this study
Official title: Effect of NNC0487-0111 on Insulin Sensitivity and Pancreatic Endocrine Function in Adults With Type 2 Diabetes
The purpose of this clinical study is to find out how NNC0487-0111 affects, how the body uses insulin (a hormone that helps the body control blood sugar) and how well the pancreas works in people living with type 2 diabetes. There are 2 study treatments. Participants will get either NNC0487-0111 (the treatment being tested) or Placebo (a treatment that has no active medicine in it). Which treatment participants get is decided by chance.
- Conditions
- Diabetes Mellitus
- Being tested
- NNC0487-0111, Placebo
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NNC0487-0111Drug
NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors to the abdomen.
PlaceboDrug
Placebo matched to NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors to the abdomen.
| Study group | Role | What they receive |
|---|---|---|
| NNC0487-0111 dose level 1 | Experimental | Participants will be randomized to receive NNC0487-0111 dose level 1 subcutaneously once weekly. Receives: Drug: NNC0487-0111 |
| NNC0487-0111 dose level 2 | Experimental | Participants will be randomized to receive NNC0487-0111 dose level 2 subcutaneously once weekly. Receives: Drug: NNC0487-0111 |
| NNC0487-0111 dose level 3 | Experimental | Participants will be randomized to receive NNC0487-0111 dose level 3 subcutaneously once weekly. Receives: Drug: NNC0487-0111 |
| Placebo | Placebo comparator | Participants will receive placebo matched to NNC0487-0111 subcutaneously once weekly. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in M-value in Hyperinsulinaemic euglycaemic clamp (HEC)
Measured as milligram per minute per kilogram (mg/min/kg)
Measured: Baseline to week 40
Secondary outcomes (11)
Change in M-value in HEC, normalised by lean body mass
Measured as mg/min/kg
Measured: Baseline to week 40
Change in first-phase incremental Insulin Secretion Rate (ISR0-8 min) in Hyperglycaemic clamp (HGC)
Measured as picomole per minute per meter square (pmol/min/m^2)
Measured: Baseline to week 40
Change in second-phase ISR (ISR20-120 min) in HGC
Measured as pmol/min/m^2
Measured: Baseline to week 40
Change in total ISR (ISR0-120 min) in HGC
Measured as pmol/min/m^2
Measured: Baseline to week 40
Change in ISR at fixed glucose concentration (ISRg) in HGC
Measured as pmol/min/m^2
Measured: Baseline to week 40
Change in total insulin response [total area under curve (AUC0-120) min] in HGC
Measured as picomole per liter per minute (min*pmol/L)
Measured: Baseline to week 40
Change in clamp disposition index (cDI) calculated from HEC and HGC
Measured as picomole per liter per meter square per minute square per kilogram (pmol*L/m^2/min^2/kg)
Measured: Baseline to week 40
Change in cDI calculated from HEC and HGC, based on lean body mass
Measured as pmol*L/m^2/min^2/kg
Measured: Baseline to week 40
Change in β-cell glucose sensitivity (insulin secretion) from HGC
Measured as picomole per minute per meter square per millimoles per liter [pmol/min/m^2/ (mmol/L)]
Measured: Baseline to week 40
Change in β-cell glucose sensitivity from mixed meal tolerance test (MMTT) (slope of dose-response for insulin secretion vs. plasma glucose)
Measured as pmol/min/m^2/ (mmol/L)
Measured: Baseline to week 40
Change in glycated haemoglobin (HbA1c)
Measured as percentage (%) of HbA1c
Measured: Baseline to week 40
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start10 Apr 2026
- Primary completion11 Nov 2027 (estimated)
- Study completion6 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07535307
- Sponsor's protocol ID
- NN9490-8153
- Other IDs
- U1111-1320-4780, 2025-521595-55, 2025
- Status last verified
- Apr 2026
- First submitted
- 9 Apr 2026
- Last updated
- 24 Apr 2026
- 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 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of NNC0487-0111 on Insulin Sensitivity and Pancreatic Endocrine Function in Adults With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT07535307
- Acronym / sponsor ID
- NN9490-8153
- Conditions
- Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 10 Apr 2026 (actual)
- Primary completion
- 11 Nov 2027 (estimated)
- Study completion
- 6 Dec 2027 (estimated)
- First posted
- 17 Apr 2026 (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 of this clinical study is to find out how NNC0487-0111 affects, how the body uses insulin (a hormone that helps the body control blood sugar) and how well the pancreas works in people living with type 2 diabetes. There are 2 study treatments. Participants will get either NNC0487-0111 (the treatment being tested) or Placebo (a treatment that has no active medicine in it). Which treatment participants get is decided by chance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| NNC0487-0111 dose level 1 | Experimental | Drug: NNC0487-0111Participants will be randomized to receive NNC0487-0111 dose level 1 subcutaneously once weekly. |
| NNC0487-0111 dose level 2 | Experimental | Drug: NNC0487-0111Participants will be randomized to receive NNC0487-0111 dose level 2 subcutaneously once weekly. |
| NNC0487-0111 dose level 3 | Experimental | Drug: NNC0487-0111Participants will be randomized to receive NNC0487-0111 dose level 3 subcutaneously once weekly. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo matched to NNC0487-0111 subcutaneously once weekly. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female.
- Age 18-75 years (both inclusive) at the time of signing the informed consent.
- Diagnosed with type 2 diabetes more than or equal to (≥)180 days before screening.
- Only stable daily dose(s) of metformin at effective or maximum tolerated dose, as judged by the investigator for at least 90 days before screening. If additional oral antidiabetic drug (OAD) is required, only stable dose(s) of sodium-glucose cotransporter-2 inhibitors (SGLT2i) is permitted, and this must also have been maintained for at least 90 days before screening.
- HbA1c at screening of 6.5-9.5% [48-80 millimole per mole (mmol/mol)] (both inclusive) if on metformin only, or 6.0-9.0% (42-75 mmol/mol) (both inclusive) if on metformin in combination with SGLT2i.
Key exclusion criteria (8 listed)
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive method.
- Presence of type 1 diabetes.
- Any clinically significant body weight change (≥5% self-reported change) or dieting attempts (e.g., participation in a weight reduction program) within 90 days before screening.
- Treatment with any medication for the indication of T2D or weight management other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days and prior insulin treatment for gestational diabetes are allowed.
- Treatment with a GLP-1 receptor agonist.
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 |
|---|---|---|
| NNC0487-0111NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors to the abdomen. | Drug | NNC0487-0111 dose level 1, NNC0487-0111 dose level 2, NNC0487-0111 dose level 3 |
| PlaceboPlacebo matched to NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors to the abdomen. | Drug | Placebo |
Primary outcome
Change in M-value in Hyperinsulinaemic euglycaemic clamp (HEC)
Time frame: Baseline to week 40
Measured as milligram per minute per kilogram (mg/min/kg)
11 secondary outcomes
Change in M-value in HEC, normalised by lean body mass
Time frame: Baseline to week 40
Change in first-phase incremental Insulin Secretion Rate (ISR0-8 min) in Hyperglycaemic clamp (HGC)
Time frame: Baseline to week 40
Change in second-phase ISR (ISR20-120 min) in HGC
Time frame: Baseline to week 40
Change in total ISR (ISR0-120 min) in HGC
Time frame: Baseline to week 40
Change in ISR at fixed glucose concentration (ISRg) in HGC
Time frame: Baseline to week 40
Change in total insulin response [total area under curve (AUC0-120) min] in HGC
Time frame: Baseline to week 40
Change in clamp disposition index (cDI) calculated from HEC and HGC
Time frame: Baseline to week 40
Change in cDI calculated from HEC and HGC, based on lean body mass
Time frame: Baseline to week 40
Change in β-cell glucose sensitivity (insulin secretion) from HGC
Time frame: Baseline to week 40
Change in β-cell glucose sensitivity from mixed meal tolerance test (MMTT) (slope of dose-response for insulin secretion vs. plasma glucose)
Time frame: Baseline to week 40
Change in glycated haemoglobin (HbA1c)
Time frame: Baseline to week 40
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- 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.
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, 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 5 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 24 Apr 2026. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novo Nordisk ((+1) 866-867-7178, clinicaltrials@novonordisk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in M-value in Hyperinsulinaemic euglycaemic clamp (HEC) (time frame: Baseline to week 40). 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 24 Apr 2026.