A Research Study to Evaluate the Safety of NNC1679-0001 When Given to Healthy Participants and Pa… (NCT07570992) | Clinical Trial Compass
RecruitingPhase 1
A Research Study to Evaluate the Safety of NNC1679-0001 When Given to Healthy Participants and Participants With T2DM
Austria58 participantsStarted 2026-05-04
Plain-language 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.
Who can participate
Age range
18 Years – 64 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 1 trial primarily measuring the number of adverse events, what does that mean about how much is currently known about the safety of NNC1679-0001 in people with Type 2 diabetes?
2This study is enrolling both healthy volunteers and people with Type 2 diabetes — would my specific health history and current diabetes medications affect whether this trial might even be appropriate for me to consider?
3Because the main goal here is to evaluate safety rather than to treat my diabetes, how does participating in this study compare to continuing or starting a standard Type 2 diabetes treatment?
4What kinds of side effects or treatment-emergent adverse events has my doctor seen in early-phase drug studies like this one, and how would those be monitored and managed if I were to take part?
5Given that this trial is still in its earliest phase, is there a reason my doctor would suggest I look at this now versus waiting until more safety and effectiveness data are available from later-phase studies?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Treatment-Emergency Adverse Events (TEAEs)