Trial · Interventional
RecruitingPhase 1Registry dataInvestigating How NNC0487-0111 Regulates Insulin of Adults With Type 2 Diabetes
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
- Ph 1
Investigating How NNC0487-0111 Regulates Insulin of Adults With Type 2 Diabetes
NCT0753530710 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.
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)
Change in M-value in HEC, normalised by lean body mass
Time frame · Baseline to week 40
Registry description
Measured as mg/min/kg
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)
Change in second-phase ISR (ISR20-120 min) in HGC
Time frame · Baseline to week 40
Registry description
Measured as pmol/min/m\^2
Change in total ISR (ISR0-120 min) in HGC
Time frame · Baseline to week 40
Registry description
Measured as pmol/min/m\^2
Change in ISR at fixed glucose concentration (ISRg) in HGC
Time frame · Baseline to week 40
Registry description
Measured as pmol/min/m\^2
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)
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)
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
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 \[pmol/min/m\^2/ (mmol/L)\]
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)
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
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