Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07535307

Investigating How NNC0487-0111 Regulates Insulin of 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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Profil Institut für Stoffwechselforschung GmbH

Neuss, 41460, Germany

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

NNC0487-0111

Drug

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

Placebo

Drug

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

Primary outcomes

  1. 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)

Secondary outcomes

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

    Time frame: Baseline to week 40

    Measured as mg/min/kg

  2. Change in first-phase incremental Insulin Secretion Rate (ISR0-8 min) in Hyperglycaemic clamp (HGC)

    Time frame: Baseline to week 40

    Measured as picomole per minute per meter square (pmol/min/m^2)

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

    Time frame: Baseline to week 40

    Measured as pmol/min/m^2

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

    Time frame: Baseline to week 40

    Measured as pmol/min/m^2

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

    Time frame: Baseline to week 40

    Measured as pmol/min/m^2

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

    Time frame: Baseline to week 40

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

  7. Change in clamp disposition index (cDI) calculated from HEC and HGC

    Time frame: Baseline to week 40

    Measured as picomole per liter per meter square per minute square per kilogram (pmol*L/m^2/min^2/kg)

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

    Time frame: Baseline to week 40

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

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

    Time frame: Baseline to week 40

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

  10. 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

    Measured as pmol/min/m^2/ (mmol/L)

  11. Change in glycated haemoglobin (HbA1c)

    Time frame: Baseline to week 40

    Measured as percentage (%) of HbA1c

Study contacts

Contact information is provided by the study sponsor or research team.

Novo Nordisk

CONTACT

[email protected]

(+1) 866-867-7178

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Effect of NNC0487-0111 on Insulin Sensitivity and Pancreatic Endocrine Function in Adults With Type 2 Diabetes

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 17, 2026
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.