A Study to See How Safe a New Medicine (NNC6022-0004) is in Healthy People and People Living With Obesity
Recruiting · NCT07693868 · Interventional (participants receive a specific treatment) · Lead sponsor: Novo Nordisk A/S
View the official record on ClinicalTrials.gov →Interventions studied
NNC6022-0004Placebo
What this trial is about
This study is being done to look at the efficacy single and multiple ascending dose study investigating safety, tolerability, pharmacokinetics, food effect and target engagement in healthy adults including a single cohort in adults living with obesity. Participants will either get NNC6022-0004, (the treatment being tested) or Placebo (a treatment that has no active medicine in it) and which treatment participants get is decided by chance.
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Male, or female of non-childbearing potential.
- For Parts A, B, C and D: Age 18-55 years (both inclusive) at the time of signing the informed consent.
- For optional Part E only: Age 18-65 years (both inclusive) at the time of signing the informed consent.
- For Parts A, B, C and D: Body mass index (BMI) between 18.5 to 29.9 kilogram per meter square (kg/m\^2) (both inclusive) at screening.
- For optional Part E only: BMI between greater than or equal to (≥) 30.0 to less than or equal to (≤) 45.0 kg/m\^2 at screening, or if BMI is between 27.0 and \<30.0 kg/m\^2, waist to height ratio should be greater than (\>)0.5.
- Body weight: ≥50.0 kilogram (kg) at screening.
- Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.
- For optional Part E only: hsCRP ≥2.00 and ≤8.00 milligrams per liter (mg/L) during screening period in 2 separate samples taken ≥4 days apart.
Exclusion criteria
- Known or suspected hypersensitivity to study intervention(s) or similar products.
- Any disorder, unwillingness or inability which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- Any of the below laboratory safety parameters at screening outside normal range, see designated reference range documents for specific values.
- Alanine Aminotransferase (ALT) \> Upper limit of normal (ULN).
- Alkaline Phosphatase (ALP) \> ULN.
- Aspartate aminotransferase (AST) \> ULN.
- Total Bilirubin (TBL) \> ULN.
- Creatinine \> ULN.
- International normalized ratio (INR) \> ULN.
- Fibrinogen outside normal range of 1.6 - 4.2 grams per liter (g/L).
- hsCRP \> 5.00 mg/L (males) and \> 8.00 mg/L (females)\*.
- applicable for Parts A, B, C and D and for optional Part E: hsCRP \>8.00 mg/L.
- Use of prescription medicinal products or vaccines within 14 days before screening and/or non prescription medicinal products within 7 days before dosing. Exceptions are: Topical medications not reaching systemic circulation; less than once per week of over-the-counter paracetamol, ibuprofen and/or acetylsalicylic acid at their labelled doses for mild pain; vitamins at their labelled doses.
Where it is running
1 location listed.
- ICON - location Groningen - Groningen, Netherlands