A Research Study to Evaluate the Safety of NNC1679-0001 When Given to Healthy Participants and Participants With T2DM
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-64
SponsorNovo Nordisk A/S
About this trial
This study is testing a new medicine that might help treat people with type 2 diabetes. The purpose of the study is to see if the new study medicine is safe and how well is tolerated by the body. There will be two groups of participants in this study: healthy participants and participants with type 2 diabetes. Participant will either get study medicine (NNC1679-0001) or placebo (a treatment that has no active medicine in it). NNC1679-0001 is a new experimental medicine that doctors cannot prescribe yet. Which treatment the participant gets is decided by chance. Participant will get one dose which will be injected into the area around abdomen (belly) by the medical staff.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine eligibility for the study.
Male or female (sex at birth) of nonchildbearing potential.
Age 18-64 years (both inclusive) at the time of signing the informed consent.
Body mass index (BMI) 18.5-29.9 kilograms per square meter (kg/m²) (both inclusive) at screening.
Disqualifiers
Screening alanine aminotransferase (ALT) values greater than (>) upper limit of normal (ULN) +10%, aspartate aminotransferase (AST) values >ULN +20%, or total bilirubin >ULN.
Renal impairment, defined as estimated glomerular filtration rate (eGFR) <60.0 milliliter per minute per 1.73 square meter (mL/min/1.73m²), at screening.
Clinical evidence of chronic kidney disease (CKD) and/or urinary albumin: creatinine ratio (UACR) >30 milligrams per gram (mg/g).
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.
Trial design
Design model
Parallel
Treatments tested in this trial
NNC1679-0001
DrugNNC1679-0001 will be administered subcutaneously.
Placebo
DrugPlacebo will be administered subcutaneously.
Treatment groups
58 Participants
are divided into 2 treatment groupsGroup A: NNC1679-0001Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of Treatment-Emergency Adverse Events (TEAEs)
Measured in events.
Time frame
From dosing (day 1) upto week 34Secondary outcomes
1
Number of TEAEs
Measured in events.
Time frame
From dosing (day 1) until V15a/V15b (week 26)2
Number of hypoglycaemic episodes
Measured in episodes.
Time frame
From dosing (day 1) upto week 343
AUC: The area under the NNC1679-0001 plasma concentration-time curve from time zero to the last measurable concentration after a single dose
Measured in hours\*nanograms per milliliter (hour × ng/mL).
Time frame
From dosing (day 1) upto day 3 or day 154
Cmax: The maximum concentration of NNC1679-0001 in plasma after a single dose
Measured in nanograms per milliliter (ng/mL).
Time frame
From dosing (day 1) upto day 3 or day 15Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov