Actively Recruiting
A Research Study of a New Medicine, NNC9733-0001, in Healthy Participants and Participants With Type 2 Diabetes
Led by Novo Nordisk A/S · Updated on 2025-12-08
72
Participants Needed
1
Research Sites
102 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Research Study of a New Medicine, NNC9733-0001, in Healthy Participants and Participants With Type 2 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided informed consent before any study-related activities
- Male, or female of nonchildbearing potential
- Healthy participants must be 18 to 45 years old at consent
- Healthy participants must have a BMI between 18.5 and 29.9 kg/m2 at screening
- Healthy participants must have HbA1c less than or equal to 6.4% at screening
- Healthy participants must be generally healthy based on medical history, exam, vital signs, ECG, and labs
- Participants with type 2 diabetes must be 18 to 64 years old at consent
- Participants with type 2 diabetes must have a BMI between 20.0 and 34.9 kg/m2 at screening
- Participants with type 2 diabetes must have HbA1c between 6.5% and 8.5% at screening
- Participants with type 2 diabetes must have been diagnosed with type 2 diabetes for at least 180 days before screening
- Participants with type 2 diabetes must be on a stable daily dose of metformin within 90 days before screening
You will not qualify if you...
- ALT values greater than upper limit of normal (ULN) +10% at screening
- AST values greater than ULN +20% at screening
- Total bilirubin greater than ULN at screening
- Estimated glomerular filtration rate (eGFR) less than 60 mL/min/1.73m2 at screening
- Clinical evidence of chronic kidney disease or urinary albumin:creatinine ratio greater than 30 mg/g
- History or presence of cardiovascular disease including angina, myocardial infarction, stroke, cardiac decompensation, arrhythmias, or conduction disorders
- Healthy participants with any disorder that may jeopardize safety or protocol compliance
- Healthy participants with supine blood pressure outside 90-139 mmHg systolic or 50-89 mmHg diastolic at screening
- Participants with type 2 diabetes with any disorder, except mild stable conditions related to diabetes, that may jeopardize safety or protocol compliance
- Participants with type 2 diabetes with supine blood pressure outside 90-159 mmHg systolic or 50-99 mmHg diastolic at screening, including those on antihypertensive treatment
AI-Screening
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Trial Site Locations
Total: 1 location
1
Profil Institut für Stoffwechselforschung GmbH
Neuss, Germany, 41460
Actively Recruiting
Research Team
N
Novo Nordisk
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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