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

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus, Type 2; Healthy Volunteers
• Intervention / Treatment: Drug: Placebo; Drug: NNC1679-0001

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 1

Contacts and Locations

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

Study Locations

• Austria
  • Graz, Austria, 8010
    • Recruiting
    • Medical University of Graz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 6.3-8.5% (45.4-69.4 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 >= 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NNC1679-0001; Participants will receive NNC1679-0001 subcutaneously.	Drug: NNC1679-0001; NNC1679-0001 will be administered subcutaneously.
Placebo Comparator: Placebo; Participants will receive placebo matched to NNC1679-0001 s.c.	Drug: Placebo; Placebo will be administered subcutaneously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Treatment-Emergency Adverse Events (TEAEs)	Measured in events.	From dosing (day 1) upto week 34

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of TEAEs	Measured in events.	From dosing (day 1) until V15a/V15b (week 26)
Number of hypoglycaemic events	Measured in events.	From dosing (day 1) upto week 34
AUC: The area under the NNC1679-0001 plasma concentration-time curve	Measured in hours*nanograms per milliliter (hour × ng/mL).	From dosing (day 1) upto day 3
Cmax: The maximum concentration of NNC1679-0001 in plasma	Measured in nanograms per milliliter (ng/mL).	From dosing (day 1) upto day 3
tmax: The time from dosing to maximum plasma concentration of NNC1679-0001	Measured in hours.	From dosing (day 1) upto day 3
t1/2: Terminal half-life for NNC1679-0001 after dosing	Measured in hours.	From dosing (day 1) upto day 3
CLR: Renal clearance of NNC1679-0001	Measured in liter per hours (L/hours).	From dosing (day 1) upto day 3

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency dept. 2834, Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2026
• Primary Completion (Estimated): June 25, 2028
• Study Completion (Estimated): June 25, 2028

Study Registration Dates

• First Submitted: April 30, 2026
• First Submitted That Met QC Criteria: April 30, 2026
• First Posted (Actual): May 6, 2026

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 15, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2
• Other Study ID Numbers: NN1679-8505; U1111-1329-6912 (Other Identifier: World Health Organization (WHO)); 2025-523304-68 (Other Identifier: European Medical Agency (EMA))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes