Menu
Recruiting NCT07570992

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

Phase I Interventional Healthy Volunteers Diabetes Mellitus, Type 2

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: NNC1679-0001, Placebo.
Who it may be relevant to
Registry conditions: Healthy Volunteers, Diabetes Mellitus, Type 2. Basic parameters: 18 years — 64 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Austria
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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.

Interventions

  • Drug NNC1679-0001
    NNC1679-0001 will be administered subcutaneously.
  • Drug Placebo
    Placebo will be administered subcutaneously.

Primary outcome measures

  • Number of Treatment-Emergency Adverse Events (TEAEs) [Time frame: From dosing (day 1) upto week 34]
Secondary outcome measures (7)
  • Number of TEAEs [Time frame: From dosing (day 1) until V15a/V15b (week 26)]
  • Number of hypoglycaemic episodes [Time frame: From dosing (day 1) upto week 34]
  • 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]
  • 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]
  • 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]
  • t1/2: Terminal half-life for NNC1679-0001 after a single dose [Time frame: From dosing (day 1) upto day 3 or day 15]
  • CLR: Renal clearance of NNC1679-0001 after a single dose [Time frame: From dosing (day 1) upto day 3]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Austria · 1 center
  • Medical University of Graz — Graz

Identifiers

NCT: NCT07570992 · NN1679-8505 · U1111-1329-6912 · 2025-523304-68

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗