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Trial · Interventional

RecruitingPhase 1Registry data

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

NCTNCT07535307 (opens ClinicalTrials.gov in a new tab)Other idNN9490-8153Other idU1111-1320-4780Other id2025-521595-55Other id2025

Overview

Status
Recruiting
Phase
Phase 1
Enrollment
80 participants (estimated)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Quadruple masking
Countries
1 country

Germany

Start
10 Apr 2026
Primary completion
11 Nov 2027 (estimated)
Completion
6 Dec 2027 (estimated)
First posted
17 Apr 2026
Last update posted
24 Apr 2026
Conditions
Diabetes Mellitus

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202620272028
  1. Ph 1

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

    NCT07535307

    10 Apr 2026 to est. 6 Dec 2027

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • NNC0487-0111Drug
  • PlaceboDrug

Arms4

  • Experimental

    NNC0487-0111 dose level 1

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

  • Experimental

    NNC0487-0111 dose level 2

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

  • Experimental

    NNC0487-0111 dose level 3

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

  • Placebo comparator

    Placebo

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

Primary outcomes1

Outcomes the sponsor listed as primary.

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

    Time frame · Baseline to week 40

    Registry description

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

Secondary outcomes(11)
  1. Change in M-value in HEC, normalised by lean body mass

    Time frame · Baseline to week 40

    Registry description

    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

    Registry description

    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

    Registry description

    Measured as pmol/min/m\^2

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

    Time frame · Baseline to week 40

    Registry description

    Measured as pmol/min/m\^2

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

    Time frame · Baseline to week 40

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

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

  11. Change in glycated haemoglobin (HbA1c)

    Time frame · Baseline to week 40

    Registry description

    Measured as percentage (%) of HbA1c

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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