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NCT Number: NCT07570992

A Research Study to Evaluate the Safety of NNC1679-0001 When Given to Healthy Participants and Participants With T2DM

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.

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Key information

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Medical University of Graz

Graz, 8010, Austria

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NNC1679-0001

Drug

NNC1679-0001 will be administered subcutaneously.

Placebo

Drug

Placebo will be administered subcutaneously.

Primary outcomes

  1. Number of Treatment-Emergency Adverse Events (TEAEs)

    Time frame: From dosing (day 1) upto week 34

    Measured in events.

Secondary outcomes

  1. Number of TEAEs

    Time frame: From dosing (day 1) until V15a/V15b (week 26)

    Measured in events.

  2. Number of hypoglycaemic episodes

    Time frame: From dosing (day 1) upto week 34

    Measured in episodes.

  3. AUC: The area under the NNC1679-0001 plasma concentration-time curve from time zero to the last measurable concentration after a single dose

    Time frame: From dosing (day 1) upto day 3 or day 15

    Measured in hours*nanograms per milliliter (hour × ng/mL).

  4. Cmax: The maximum concentration of NNC1679-0001 in plasma after a single dose

    Time frame: From dosing (day 1) upto day 3 or day 15

    Measured in nanograms per milliliter (ng/mL).

  5. tmax: The time from dosing to maximum plasma concentration of NNC1679-0001 after a single dose

    Time frame: From dosing (day 1) upto day 3 or day 15

    Measured in hours.

  6. t1/2: Terminal half-life for NNC1679-0001 after a single dose

    Time frame: From dosing (day 1) upto day 3 or day 15

    Measured in hours.

  7. CLR: Renal clearance of NNC1679-0001 after a single dose

    Time frame: From dosing (day 1) upto day 3

    Measured in liter per hours (L/hours).

Study contacts

Contact information is provided by the study sponsor or research team.

Novo Nordisk

CONTACT

[email protected]

(+1) 866-867-7178

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 6, 2026
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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