Safety of the new medicine NNC6022-0004 in healthy adults and adults with obesity

Trial details

Who runs it

Novo Nordisk A/S

Trial code

NCT07693868

Record updated

1 September 2026

Original description

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.Read full original descriptionShow less

An NNC6022-0004 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

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.

Inclusion: 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: 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; 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.

ClinicalTrials.gov NCT07693868