A Research Study of a New Medicine, NNC9733-0001, in Healthy Participants and Participants With Type 2 Diabetes

Investigation of Safety, Tolerability, Pharmacokinetic and Pharmacodynamics of Single Administrations of NNC9733-0001 in Healthy Participants and in Participants With Type 2 Diabetes

This study is testing a new medicine that might help treat people with type 2 diabetes. The study is conducted to see if the new medicine can lower high sugar levels in the blood. 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 partici-pants in this study: healthy participants and participants with type 2 diabetes. Participant will either get study medicine (NNC9733-0001) or placebo (a treatment that has no active medicine in it). Which treatment the participant gets is decided by chance. Which dose (strength) the participant get is determined by when participant enter the study. Participant will get one dose which will be injected into the area around abdomen (belly) by the medical staff. The number of injections (up to 4 injections) will depend on the group the participant is assigned to. Larger doses require multiple injections. The study will last for about 40 weeks (10 months).

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes; Healthy Volunteer
• Intervention / Treatment: Drug: NNC9733-0001; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Phase 1

Contacts and Locations

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

Study Locations

• Germany
  • Neuss, Germany, 41460
    • Recruiting
    • Profil Institut für Stoffwechselforschung GmbH

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 of nonchildbearing potential

Healthy participants

• Age 18-45 years (both inclusive) at the time of signing the informed consent.
• Body Mass Index (BMI) between 18.5 and 29.9 kilogram per meter square (kg/m^2) (both inclusive) at screening.
• Glycosylated haemoglobin (HbA1c) less 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, Electrocardiography (ECG), and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Participants with T2DM

• Age 18-64 years (both inclusive) at the time of signing the informed consent.
• BMI between 20.0 and 34.9 kg/m^2 (both inclusive) at screening.
• HbA1c 6.5-8.5% (47.5-69.4 mmol/mol) at screening.
• Diagnosed with type 2 diabetes mellitus (T2DM) greater than or equal to (≥) 180 days before screening.
• Stable daily dose(s) of metformin within 90 days before screening.

Exclusion Criteria:

• Screening alanine transaminase (ALT) values greater than (>) upper limit of normal (ULN) +10 per-cent (%), AST values >ULN +20%, or total bilirubin >ULN.
• Renal impairment, defined as estimated glomerular filtration rate (eGFR) less than (<) 60.0 millilitre per minute per 1.73-meter square (mL/min/1.73m^2), at screening.
• Clinical evidence of Chronic Kidney Disease (CKD) and/or urinary albumin:creatinine ratio (UACR) >30 milligram 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, which 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 millimetres 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: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NNC9733-0001; Participants will be administered a single dose of NNC9733-0001 in a dose escalated manner.	Drug: NNC9733-0001; Administered a single dose of NNC9733-0001.
Experimental: Placebo; Participants will be administered a single dose of matching NNC9733-0001 placebo in a dose escalated manner.	Drug: Placebo; Administered a single dose of matching NNC9733-0001 placebo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of treatment emergent adverse events (TEAEs)	Measured as number of events	From dosing (day 1) until end of study (EOS) visit (week 36)
Number of hypoglycaemic events	Measured as number of events	From dosing (day 1) until end of study (EOS) visit (week 36)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC0-last: The area under the NNC9733-0001 plasma concentration-time curve from time zero to last measurable concentration after a single dose	Measured in hours × nanogram/millilitre (ng/mL)	From dosing (day 1) to 48 hours after dosing
Cmax: The maximum concentration of NNC9733-0001 in plasma	Measured in nanogram/millilitre (ng/mL)	From dosing (day 1) to 48 hours after dosing
tmax: The time from dose administration to maximum plasma concentration of NNC9733-0001	Measured in hours	From dosing (day 1) to 48 hours after dosing
t1/2: Terminal half-life for NNC9733-0001 after a single dose	Measured in hours	From dosing (day 1) to 48 hours after dosing

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): November 25, 2025
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): November 12, 2027

Study Registration Dates

• First Submitted: November 25, 2025
• First Submitted That Met QC Criteria: November 26, 2025
• First Posted (Actual): December 8, 2025

Study Record Updates

• Last Update Posted (Actual): December 8, 2025
• Last Update Submitted That Met QC Criteria: November 26, 2025
• Last Verified: November 1, 2025

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: NN9733-8133; U1111-1314-8868 (Other Identifier: World Health Organization (WHO)); 2024-519382-22 (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: No
• Studies a U.S. FDA-regulated device product: No