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

NCT07570992 | Not Yet Recruiting Phase 1 FDA Drug

• 3 other identifiers: NN1679-8505U1111-1329-69122025-523304-68
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Number of Treatment-Emergency Adverse Events (TEAEs)

  Measured in events.

  From dosing (day 1) upto week 34

Secondary Outcomes (7)

• Number of TEAEs

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

• Number of hypoglycaemic events

  From dosing (day 1) upto week 34

• AUC: The area under the NNC1679-0001 plasma concentration-time curve

  From dosing (day 1) upto day 3

• Cmax: The maximum concentration of NNC1679-0001 in plasma

  From dosing (day 1) upto day 3

• tmax: The time from dosing to maximum plasma concentration of NNC1679-0001

  From dosing (day 1) upto day 3

Study Arms (2)

NNC1679-0001

EXPERIMENTAL

Participants will receive NNC1679-0001 subcutaneously.

Drug: NNC1679-0001

Placebo

PLACEBO COMPARATOR

Participants will receive placebo matched to NNC1679-0001 s.c.

Drug: Placebo

Interventions

NNC1679-0001 DRUG

NNC1679-0001 will be administered subcutaneously.

NNC1679-0001

Placebo DRUG

Placebo will be administered subcutaneously.

Placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Medical University of Graz

Graz, 8010, Austria

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Clinical Transparency dept. 2834

  Novo Nordisk A/S

  STUDY DIRECTOR

Central Study Contacts

Novo Nordisk

CONTACT

(+1) 866-867-7178; clinicaltrials@novonordisk.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: May 6, 2026
• Study Start: May 4, 2026
• Primary Completion (Estimated): June 25, 2028
• Study Completion (Estimated): June 25, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

AU (1)