ICON - location Groningen
Groningen, 9728 NZ, Netherlands
NCT Number: NCT07693868
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.
Trial opening soon.
Get Notified18 year–65 year
All sexes
Interventional
Phase 1
Groningen, 9728 NZ, Netherlands
The study consists of 5 Parts (Parts A to E and the participants will be assessed based on the study intervention received (NNC6022-0004 or Placebo).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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.
Exclusion criteria
Participants will receive single dose of NNC6022-0004 administered orally in capsule form.
Participants will receive placebo matched to NNC6022-0004 administered orally in capsule form.
Time frame: From pre-dose (Day 1) until visit 3 (Day 9)
Measured as micromolar per hour (µM*h).
Time frame: From pre-dose (Day 1) until visit 3 (Day 9)
Measured as micromolar (µM).
Time frame: From time of dosing (Day 1) to end of study visit (Day 14)
Measured as number of events.
Time frame: From time of dosing (Day 1) to end of study visit (Day 41)
Measured as number of events.
Time frame: From pre-dose (Day 1 or Day 8) to end of visit (Day 5 or Day 12)
Measured as µM*h.
Time frame: From time of dosing (Day 1) to end of study visit (Day 13)
Measured as number of events.
Time frame: From pre-dose (Day 1) until visit 3 (Day 9)
Measured as µM*h.
Time frame: From time of dosing (Day 1) to end of study visit (Day 9)
Measured as number of events.
Time frame: From pre-dose (Day 1) until visit 3 (Day 9)
Measured as µM*h.
Time frame: From pre-dose (Day 1) until visit 3 (Day 9)
Measured as µM*h.
Time frame: From pre-dose (Day 1) until visit 3 (Day 9)
Measured as µM.
Time frame: From dose (Day 1) until 72h post-dose
Measured as proportion of dose.
Time frame: From pre-dose (Day 28) to tau after last dose (Day 29)
Measured as µM*h.
Time frame: From pre-dose (Day 28) until visit 3 (Day 35)
Measured as µM.
Time frame: From pre-dose (Day 1) to tau after last dose (Day 29)
Measured as ratio
Time frame: From pre-dose (Day 1 or Day 8) to end of visit (Day 5 or Day 12)
Measured as µM*h.
Time frame: From pre-dose (Day 1 or Day 8) to end of visit (Day 5 or Day 12)
Measured as µM.
Time frame: From time of dosing (Day 1) to end of visit (Day 16)
Measured as number of events.
Time frame: From pre-dose (Day 1) to tau after last dose (Day 8)
Measured as ratio.
Time frame: From pre-dose (Day 7) to tau after last dose (Day 8)
Measured as µM*h .
Time frame: From pre-dose (Day 7) until visit 3 (Day 13)
Measured as µM.
Contact information is provided by the study sponsor or research team.
Novo Nordisk A/S
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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