See if a new medicine NNC1679-0001 is safe in healthy people and in type 2 diabetes patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 interventional study tests a new medicine called NNC1679-0001 in two groups: healthy adults and adults with type 2 diabetes. Participants are randomized to receive either the study drug or a placebo once via injection near the abdomen. The study aims to assess safety and how the body handles the medicine, including tolerability and preliminary pharmacokinetics. Eligibility includes adults aged 18-64, with separate criteria for healthy participants and for those with type 2 diabetes. The trial is sponsored by Novo Nordisk A/S and conducted at the Medical University of Graz in Austria.

Why it matters

Who can join: the full rules

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.

Where it's running

• Medical University of Graz
  Graz, Austria Recruiting

Study contacts

• Study coordinator: Novo Nordisk
• Email: clinicaltrials@novonordisk.com
• Phone: (+1) 866-867-7178

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.