New diabetes drug candidate enters early human safety trials
NCT ID NCT07270731
First seen Jun 27, 2026 · Last updated Jul 21, 2026 · Updated 2 times
Summary
This early-stage study tests a new medicine (NNC9733-0001) to see if it is safe and tolerable in healthy volunteers and people with type 2 diabetes. Participants receive either the study drug or a placebo as a single injection. The goal is to check for side effects and how the drug affects blood sugar levels over about 10 months.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 64 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 6.5-9.0% (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. 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.
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Profil Institut für Stoffwechselforschung GmbH
RECRUITINGNeuss, 41460, Germany
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