Language: BG BG
← Back to results
Recruiting Phase 1 NCT07535307

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

Phase 1 – testing safety in a small group of people
Conditions: Diabetes Mellitus

Sponsor: Novo Nordisk A/S

trial.available_in: БГ
Overview
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.
Who can participate
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.
Interventions
NNC0487-0111
DRUG
Placebo
DRUG
Locations 1
Germany (1)
Profil Institut für Stoffwechselforschung GmbH
Neuss
Technical details
Status
Recruiting
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
75 Years
Healthy volunteers
No
Start date
10.04.2026
Completion date
06.12.2027
Registry ID
NCT07535307
Source
clinicaltrials.gov
trial.inquiry_btn

Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.