Actively Recruiting
Safety and Tolerability Study of NNC1679-0001 in Healthy Adults and Adults With Type 2 Diabetes
Led by Novo Nordisk A/S · Updated on 2026-05-19
80
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new experimental medicine called NNC1679-0001 to see if it is safe and well tolerated in people with type 2 diabetes as well as in healthy participants. The study is a phase 1, double-blinded, placebo-controlled trial designed to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of single ascending doses of this medicine. Participants include both healthy adults and adults diagnosed with type 2 diabetes. Participants will be randomly assigned to receive either NNC1679-0001 or a placebo, both given as a single subcutaneous injection near the abdomen by medical staff. The study has two groups: healthy volunteers and people with type 2 diabetes. The random assignment means neither the participants nor the researchers know who receives the medicine or placebo during the study. During the study, participants will be monitored for treatment-emergent adverse events up to 34 weeks after dosing. Researchers will also measure the medicine's concentration in the blood over the first three days and track other outcomes such as hypoglycemic events. Safety assessments include physical exams, vital signs, ECGs, and lab tests. The total participation period includes follow-up visits to closely observe any effects or side effects of the injection.
CONDITIONS
Brief Title
A Research Study to Evaluate the Safety of NNC1679-0001 When Given to Healthy Participants and Participants With T2DM
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Informed consent obtained before any study-related activities.
- Male or female of nonchildbearing potential.
- Age 18 to 64 years at the time of consent.
- For healthy participants: BMI 18.5-29.9 kg/m² and HbA1c ≤ 6.4% at screening.
- For healthy participants: Considered generally healthy based on medical history, physical exam, vital signs, ECG, and lab tests.
- For participants with type 2 diabetes: BMI 20.0-34.9 kg/m² and HbA1c 6.3-8.5% at screening.
- Diagnosed with type 2 diabetes at least 180 days before screening.
- Stable daily dose(s) of metformin or metformin with DPP-4 inhibitors for at least 90 days before screening.
You will not qualify if you...
- ALT > upper limit of normal (ULN) +10%, AST > ULN +20%, or total bilirubin > ULN at screening.
- Renal impairment with eGFR < 60 mL/min/1.73m².
- Chronic kidney disease or urinary albumin:creatinine ratio > 30 mg/g.
- History or presence of cardiovascular disease including angina, heart attack, stroke, cardiac decompensation, arrhythmias, or conduction disorders.
- For healthy participants: Any disorder that might risk safety or protocol compliance.
- For healthy participants: Supine blood pressure outside 90-139 mmHg systolic or 50-89 mmHg diastolic.
- For participants with type 2 diabetes: Any disorder except mild stable conditions related to diabetes that might risk 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 blood pressure medication.
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.
Duration - Up to 34 weeks from dosing (day 1)
Participants receive NNC1679-0001 or placebo administered subcutaneously.
Trial Site Locations
Total: 1 location
1
Medical University of Graz
Graz, Austria, 8010
Actively Recruiting
Research Team
N
Novo Nordisk
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
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