A Study to See How Safe a New Medicine (NNC6022-0004) is in Healthy People and People Living With Obesity
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNovo Nordisk A/S
About this trial
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.
Eligibility criteria
Qualifiers
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.
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- NNC6022-0004
- Placebo
Treatment groups
128 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov