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

NCT07270731 | Recruiting Phase 1

• 3 other identifiers: NN9733-8133U1111-1314-88682024-519382-22
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Healthy Volunteer; Type 2 Diabetes

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• AUC0-last: The area under the NNC9733-0001 plasma concentration-time curve from time zero to last measurable concentration after a single dose

  From dosing (day 1) to 48 hours after dosing

• Cmax: The maximum concentration of NNC9733-0001 in plasma

  From dosing (day 1) to 48 hours after dosing

• tmax: The time from dose administration to maximum plasma concentration of NNC9733-0001

  From dosing (day 1) to 48 hours after dosing

• t1/2: Terminal half-life for NNC9733-0001 after a single dose

  From dosing (day 1) to 48 hours after dosing

Study Arms (2)

NNC9733-0001

EXPERIMENTAL

Participants will be administered a single dose of NNC9733-0001 in a dose escalated manner.

Drug: NNC9733-0001

Placebo

EXPERIMENTAL

Participants will be administered a single dose of matching NNC9733-0001 placebo in a dose escalated manner.

Drug: Placebo

Interventions

NNC9733-0001 DRUG

Administered a single dose of NNC9733-0001.

NNC9733-0001

Placebo DRUG

Administered a single dose of matching NNC9733-0001 placebo.

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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Profil Institut für Stoffwechselforschung GmbH

Neuss, 41460, Germany

RECRUITING

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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 8, 2025
• Study Start: November 25, 2025
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): November 12, 2027
• Last Updated: December 8, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)