NCT07570992 A Research Study to Evaluate the Safety of NNC1679-0001 When Given to Healthy Participants and Participants With T2DM
| NCT ID | NCT07570992 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Novo Nordisk A/S |
| Condition | Healthy Volunteers |
| Study Type | INTERVENTIONAL |
| Enrollment | 58 participants |
| Start Date | 2026-05-04 |
| Primary Completion | 2028-06-25 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 58 participants in total. It began in 2026-05-04 with a primary completion date of 2028-06-25.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: 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. Exclusion Criteria: All participants * 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). * 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. * 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 * 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. * 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.
Contact & Investigator
Clinical Transparency dept. 2834
STUDY DIRECTOR
Novo Nordisk A/S
Frequently Asked Questions
Who can join the NCT07570992 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 64 Years, studying Healthy Volunteers. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07570992 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07570992 currently recruiting?
Yes, NCT07570992 is actively recruiting participants. Contact the research team at clinicaltrials@novonordisk.com for enrollment information.
Where is the NCT07570992 trial being conducted?
This trial is being conducted at Graz, Austria.
Who is sponsoring the NCT07570992 clinical trial?
NCT07570992 is sponsored by Novo Nordisk A/S. The principal investigator is Clinical Transparency dept. 2834 at Novo Nordisk A/S. The trial plans to enroll 58 participants.