NCT07570992RecruitingPhase 1
A Research Study to Evaluate the Safety of NNC1679-0001 When Given to Healthy Participants and Participants With T2DM
A Phase 1,Double-blinded,Placebo-controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of NNC1679-0001 When Administered to Healthy Participants and Participants With T2DM
Source: ClinicalTrials.gov · Last updated 22 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 58 (estimated)
- First submitted
- 30 Apr 2026
- Start date
- 4 May 2026
- Primary completion date
- 25 Jun 2028
- Lead sponsor
- Novo Nordisk A/S
- Diseases
- Type 1 diabetes, Type 2 diabetes
- NCT number
- NCT07570992
- EU CT number
- 2025-523304-68-00
- EudraCT number
- 2025-523304-68
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 58
- From 4 May 2026 to the primary completion date, 25 Jun 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for healthy adults and adults with type 2 diabetes to test the safety of a new medicine, NNC1679-0001, given as a single injection.
- Age
- 18 to 64 years.
- Sex
- Men and women who cannot have children.
- Disease stage
- Healthy volunteers, or people with type 2 diabetes for at least 180 days and HbA1c 6.5-9.0%.
- Earlier treatment
- People with type 2 diabetes must take a stable daily dose of metformin, or metformin with DPP-4 inhibitors and/or SGLT 2 inhibitors, for at least 90 days.
- Biomarker or test result
- Healthy volunteers need HbA1c of 6.4% or lower. BMI 18.5-29.9 kg/m^2 for healthy volunteers, 20.0-34.9 kg/m^2 for people with type 2 diabetes.
Main reasons for not taking part
- Kidney problems (eGFR below 60.0 or chronic kidney disease)
- Liver test results above the limits set in the record
- Present or past heart or blood vessel disease, such as angina, heart attack, stroke or serious arrhythmia
- Blood pressure outside the range set for the group
- Any disorder the investigator thinks could risk safety or following the protocol
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Supine blood pressure at screening outside the range of 90-159 mmHg for systolic or 50-99 mmHg for diastolic. This exclusion criterion also pertains to those participants who are receiving antihypertensive treatment.
Other illness
- 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.
- Healthy participants
- Any disorder that, in the investigator's opinion, might jeopardise participants' safety or compliance with the protocol.
- Any disorder except for mild conditions under stable treatment associated with T2DM, which in the investigator's opinion might jeopardise participant safety or compliance with the protocol.
Lab values
- 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/1.73m\^2), at screening.
- Clinical evidence of chronic kidney disease (CKD) and/or urinary albumin: creatinine ratio (UACR) >30 milligrams per gram (mg/g).
Other
- All participants
- Supine blood pressure at screening outside the range of 90-139 millimeters of mercury (mmHg) for systolic or 50-89 mmHg for diastolic.
- Participants with T2DM
Who the study is looking for
- All participants
- 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.
- Healthy participants
- Body mass index (BMI) 18.5-29.9 kilograms per square meter (kg/m\^2) (both inclusive) at screening.
- Glycated haemoglobin (HbA1c) lesser than or equal to (<=) 6.4 percent (%) (47 [millimoles per mole] mmol/mol) at screening.
- Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiograms (ECG), and clinical laboratory tests performed during the screening visit, as judged by the investigator.
- Participants with Type 2 Diabetes Mellitus (T2DM)
- BMI 20.0-34.9 kg/m\^2 (both inclusive) at screening.
- HbA1c 6.5-9.0% (47.5-74.9 mmol/mol) at screening.
- Diagnosed with T2DM greater than or equal to (>=)180 days before screening.
- Stable (as judged by the investigator) daily dose(s) of metformin or combination of metformin and dipeptidyl peptidase IV (DPP-4) inhibitors and/or sodium-glucose co-transport 2 SGLT 2) inhibitors >= 90 days before screening.
Age in the registry: 18 years to 64 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University of Graz | Graz | Austria | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.