Actively Recruiting
Investigation of Safety, Tolerability, Pharmacokinetic and Pharmacodynamics of Single Administrations of NNC9733-0001 in Healthy Participants and in Participants With Type 2 Diabetes
Led by Novo Nordisk A/S · Updated on 2025-12-08
72
Participants Needed
1
Research Sites
10 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new medicine called NNC9733-0001 to see if it can help treat people with type 2 diabetes by lowering high blood sugar levels. The study also aims to check the safety and how well the body tolerates this medicine. There are two groups of participants: healthy volunteers and people with type 2 diabetes. Participants will receive either the study medicine or a placebo, which contains no active medicine, assigned by chance. Participants will get a single dose of the study medicine or placebo injected around the belly area by medical staff. The dose strength and number of injections, up to four, depend on the group the participant is assigned to, with larger doses requiring more injections. The treatment is given only once. The study lasts about 40 weeks (10 months). During the study, participants will be monitored for side effects and safety, including the number of adverse events and low blood sugar episodes from dosing until week 36. Researchers will also measure how the medicine moves and acts in the body through blood tests up to 48 hours after dosing. Participants will have medical exams, laboratory tests, and ECGs to check their health and response to the treatment throughout the study.
CONDITIONS
Brief 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...
- Informed consent obtained before any study-related activities
- Male, or female of nonchildbearing potential
- For healthy participants: age 18-45 years at consent
- For healthy participants: BMI between 18.5 and 29.9 kg/m² at screening
- For healthy participants: HbA1c ≤ 6.4% (47 mmol/mol) at screening
- Healthy participants must be generally healthy based on medical history, exam, vital signs, ECG, and lab tests
- For participants with type 2 diabetes: age 18-64 years at consent
- For participants with type 2 diabetes: BMI between 20.0 and 34.9 kg/m² at screening
- For participants with type 2 diabetes: HbA1c 6.5-8.5% (47.5-69.4 mmol/mol) at screening
- Diagnosed with type 2 diabetes for at least 180 days before screening
- Stable daily dose(s) of metformin within 90 days before screening
You will not qualify if you...
- ALT values > upper limit of normal (ULN) +10%, AST values > ULN +20%, or total bilirubin > ULN at screening
- Renal impairment with eGFR < 60 mL/min/1.73m² at screening
- Clinical evidence of chronic kidney disease or urinary albumin:creatinine ratio > 30 mg/g
- History or presence of cardiovascular disease including angina, myocardial infarction, stroke, heart failure, significant arrhythmias, or conduction disorders
- For healthy participants: any disorder risking safety or protocol compliance
- For healthy participants: supine blood pressure outside 90-139 mmHg systolic or 50-89 mmHg diastolic at screening
- For participants with type 2 diabetes: any disorder except mild stable conditions related to diabetes risking safety or compliance
- For participants with type 2 diabetes: supine blood pressure outside 90-159 mmHg systolic or 50-99 mmHg diastolic, including those on antihypertensive treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day dosing with assessments up to 48 hours after dosing
Participants receive a single dose of the study medicine or placebo to evaluate safety, tolerability, and pharmacokinetics.
1 dosing visit and multiple assessments within 48 hours
Duration - Up to 36 weeks after dosing
Participants are monitored for safety and any adverse events for up to 36 weeks after dosing.
Periodic visits until the end of the study visit at week 36
Trial Site Locations
Total: 1 location
1
Profil Institut für Stoffwechselforschung GmbH
Neuss, Germany, 41460
Actively Recruiting
Research Team
N
Novo Nordisk
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here