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Healthy VolunteerPhase 1NCT07270731

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

A Phase 1 study testing NNC9733-0001 in people with Healthy Volunteer and Type 2 Diabetes, run by Novo Nordisk A/S at 1 site in Germany.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 64 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteer, Type 2 Diabetes
What is being tested?
NNC9733-0001
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteGermany
Study dates
25 Nov 2025to 15 Mar 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.
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  • 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 6.5-9.0% (47.5-74.9 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 or in combination with SGLT2 inhibitors and/or dipeptidyl peptidase IV (DPP-4) inhibitors are allowed, within 90 days before screening.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Novo Nordisk contact

(+1) 866-867-7178

clinicaltrials@novonordisk.com

Germany1 site, 1 recruiting

  • Profil Institut für Stoffwechselforschung GmbH

    Neuss, 41460

    Recruiting

Other trials in Germany

About this study

Official title: 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).

Being tested
NNC9733-0001, Placebo
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NNC9733-0001Drug

    Administered a single dose of NNC9733-0001.

  • PlaceboDrug

    Administered a single dose of matching NNC9733-0001 placebo.

Study groups in NCT07270731
Study groupRoleWhat they receive
NNC9733-0001ExperimentalParticipants will be administered a single dose of NNC9733-0001 in a dose escalated manner.
Receives: Drug: NNC9733-0001
PlaceboExperimentalParticipants will be administered a single dose of matching NNC9733-0001 placebo in a dose escalated manner.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of treatment emergent adverse events (TEAEs)

    Measured as number of events

    Measured: From dosing (day 1) until end of study (EOS) visit (week 36)

  2. Number of hypoglycaemic episodes

    Measured as number of episodes

    Measured: From dosing (day 1) until end of study (EOS) visit (week 36)

Secondary outcomes (5)

  1. AUC0-last,SD: The area under the NNC9733-0001 plasma concentration-time curve from time zero to last measured concentration above LLQO after a single dose

    Measured in hours × nanogram/millilitre (ng/mL)

    Measured: From dosing (day 1) to 48 hours after dosing

  2. Cmax: The maximum concentration of NNC9733-0001 in plasma

    Measured in nanogram/millilitre (ng/mL)

    Measured: From dosing (day 1) to 48 hours after dosing

  3. tmax, SD: The time from dose administration to maximum plasma concentration of NNC9733-0001

    Measured in hours

    Measured: From dosing (day 1) to 48 hours after dosing

  4. t1/2, SD: Terminal half-life for NNC9733-0001 after a single dose

    Measured in hours

    Measured: From dosing (day 1) to 48 hours after dosing

  5. CLR,SD: Renal clearance of NNC9733 0001

    Measured in litre/hour

    Measured: From dosing (day 1) to 48 hours after dosing

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2025
  2. Study start25 Nov 2025
  3. Primary completion15 Mar 2028 (estimated)
  4. Study completion15 Mar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07270731
Sponsor's protocol ID
NN9733-8133
Other IDs
U1111-1314-8868, 2024-519382-22
Status last verified
Jul 2026
First submitted
25 Nov 2025
Last updated
20 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing NNC9733-0001 in people with Healthy Volunteer and Type 2 Diabetes, run by Novo Nordisk A/S at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Novo Nordisk ((+1) 866-867-7178, clinicaltrials@novonordisk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of treatment emergent adverse events (TEAEs) (time frame: From dosing (day 1) until end of study (EOS) visit (week 36)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07270731.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.

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