NNC9733-0001 for adults with type 2 diabetes and healthy volunteers
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
Run by Novo Nordisk A/S · NCT07270731 · Data updated 2026-11-12
This study will try a single injected dose of NNC9733-0001 to see if it is safe, well tolerated, and lowers blood sugar in adults with type 2 diabetes, with healthy volunteers included for comparison.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Novo Nordisk A/S Industry-sponsored |
| Locations | 1 site (Neuss) |
| Status | Recruiting |
| Started | November 25, 2025 |
| Main results expected | March 15, 2028 |
| Study ends | March 15, 2028 |
| Registry record updated | July 20, 2026 |
| Trial ID | NCT07270731 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with type 2 diabetes aged 18–64 who are eligible for a single-dose phase 1 injection study, as well as healthy volunteers aged 18–45 with BMI 18.5–29.9 kg/m2 and HbA1c ≤6.4%.
✕Probably not a fit
People who are pregnant, of childbearing potential without required contraception, under 18, or with unstable medical conditions or on long-term diabetes therapies are unlikely to benefit from this single-dose Phase 1 trial.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 1, randomized, placebo-controlled study gives a single subcutaneous dose of NNC9733-0001 (or placebo) to cohorts of healthy volunteers and adults with type 2 diabetes to measure safety, tolerability, and effects on blood glucose. Dose level and number of abdominal injections (up to four for larger doses) are determined by cohort and assigned by chance. Participants are followed for safety, pharmacokinetics, and pharmacodynamic outcomes over about 40 weeks, including screening, dosing, and multiple follow-up visits. The study is conducted at a single site in Neuss, Germany.
Why it matters
Potential benefit: If successful, NNC9733-0001 could become a new injectable option that safely lowers blood sugar in people with type 2 diabetes.
How similar studies have gone: Other early-phase trials of injectable diabetes medicines have often shown glucose-lowering signals and acceptable safety profiles, but NNC9733-0001 itself appears to be a novel compound being tested in humans for the first time.
Who can join: the full rules
Show full inclusion / exclusion 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 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.
Where it's running
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Profil Institut für Stoffwechselforschung GmbH
Neuss, Germany Recruiting
Study contacts
- Study coordinator: Novo Nordisk
- Email: clinicaltrials@novonordisk.com
- Phone: (+1) 866-867-7178
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.