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RecruitingNCT07535307Updated Apr 24, 2026

Investigating How NNC0487-0111 Regulates Insulin of Adults With Type 2 Diabetes

A Phase 1 interventional study of NNC0487-0111 and Placebo in Diabetes Mellitus, sponsored by Novo Nordisk A/S. Recruiting at 1 site in Germany. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-04-24.

Sponsored by Novo Nordisk A/S · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Apr 2026; still recruiting 5 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Diabetes Mellitus

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03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's planned enrollment of 80 is close to the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    NNC0487-0111 dose level 1

    Participants will be randomized to receive NNC0487-0111 dose level 1 subcutaneously once weekly.

    Drug: NNC0487-0111

  • Experimental
    NNC0487-0111 dose level 2

    Participants will be randomized to receive NNC0487-0111 dose level 2 subcutaneously once weekly.

    Drug: NNC0487-0111

  • Experimental
    NNC0487-0111 dose level 3

    Participants will be randomized to receive NNC0487-0111 dose level 3 subcutaneously once weekly.

    Drug: NNC0487-0111

  • Placebo comparator
    Placebo

    Participants will receive placebo matched to NNC0487-0111 subcutaneously once weekly.

    Drug: Placebo

Interventions

  • DrugNNC0487-0111

    NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors to the abdomen.

  • DrugPlacebo

    Placebo matched to NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors to the abdomen.

06

What researchers measure

Primary outcomes

  1. Change in M-value in Hyperinsulinaemic euglycaemic clamp (HEC)

    Measured as milligram per minute per kilogram (mg/min/kg)

    Time frame: Baseline to week 40

Secondary outcomes

  1. Change in M-value in HEC, normalised by lean body mass

    Measured as mg/min/kg

    Time frame: Baseline to week 40

  2. 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)

    Time frame: Baseline to week 40

  3. Change in second-phase ISR (ISR20-120 min) in HGC

    Measured as pmol/min/m\^2

    Time frame: Baseline to week 40

  4. Change in total ISR (ISR0-120 min) in HGC

    Measured as pmol/min/m\^2

    Time frame: Baseline to week 40

  5. Change in ISR at fixed glucose concentration (ISRg) in HGC

    Measured as pmol/min/m\^2

    Time frame: Baseline to week 40

  6. Change in total insulin response [total area under curve (AUC0-120) min] in HGC

    Measured as picomole per liter per minute (min\*pmol/L)

    Time frame: Baseline to week 40

  7. 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)

    Time frame: Baseline to week 40

  8. Change in cDI calculated from HEC and HGC, based on lean body mass

    Measured as pmol\*L/m\^2/min\^2/kg

    Time frame: Baseline to week 40

  9. Change in β-cell glucose sensitivity (insulin secretion) from HGC

    Measured as picomole per minute per meter square per millimoles per liter \[pmol/min/m\^2/ (mmol/L)\]

    Time frame: Baseline to week 40

  10. 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)

    Time frame: Baseline to week 40

  11. Change in glycated haemoglobin (HbA1c)

    Measured as percentage (%) of HbA1c

    Time frame: Baseline to week 40

07

Study locations

1 of 1 sites recruiting
  • Profil Institut für Stoffwechselforschung GmbH
    Neuss, 41460, Germany
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07535307
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Apr 17, 2026
Start date
Apr 10, 2026
Primary completion
Nov 11, 2027 (estimated)
Completion
Dec 6, 2027 (estimated)
Last update
Apr 24, 2026

Study contacts

Novo Nordisk
Contact
clinicaltrials@novonordisk.com
(+1) 866-867-7178
Clinical Transparency (dept. 2834)
study director · Novo Nordisk A/S

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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