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NCT Number: NCT07693868

A Study to See How Safe a New Medicine (NNC6022-0004) is in Healthy People and People 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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

ICON - location Groningen

Groningen, 9728 NZ, Netherlands

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NNC6022-0004

Drug

Participants will receive single dose of NNC6022-0004 administered orally in capsule form.

Placebo

Drug

Participants will receive placebo matched to NNC6022-0004 administered orally in capsule form.

Primary outcomes

  1. Part A: Area under the NNC6022-0001 plasma concentration-time curve from time 0 to last measurable plasma concentration (AUC0-tz) after a single dose

    Time frame: From pre-dose (Day 1) until visit 3 (Day 9)

    Measured as micromolar per hour (µM*h).

  2. Part A: Maximum observed plasma concentration (Cmax) of NNC6022-0001 after a single dose

    Time frame: From pre-dose (Day 1) until visit 3 (Day 9)

    Measured as micromolar (µM).

  3. Part B: Number of treatment emergent adverse events (TEAE)

    Time frame: From time of dosing (Day 1) to end of study visit (Day 14)

    Measured as number of events.

  4. Part C: Number of treatment emergent adverse events

    Time frame: From time of dosing (Day 1) to end of study visit (Day 41)

    Measured as number of events.

  5. Part D: Area under the NNC6022-0001 plasma concentration-time curve from time 0 to last measurable plasma concentration (AUC0-tz) after a single dose

    Time frame: From pre-dose (Day 1 or Day 8) to end of visit (Day 5 or Day 12)

    Measured as µM*h.

  6. Part E: Number of treatment emergent adverse events

    Time frame: From time of dosing (Day 1) to end of study visit (Day 13)

    Measured as number of events.

Secondary outcomes

  1. Part A: The area under the NNC6022-0001 plasma concentration-time curve from time 0 to infinity (AUC0-∞) after a single dose

    Time frame: From pre-dose (Day 1) until visit 3 (Day 9)

    Measured as µM*h.

  2. Part A: Number of treatment emergent adverse events

    Time frame: From time of dosing (Day 1) to end of study visit (Day 9)

    Measured as number of events.

  3. Part B: The area under the NNC6022-0001 plasma concentration-time curve from time 0 to last measurable plasma concentration (AUC0-tz) after a single dose

    Time frame: From pre-dose (Day 1) until visit 3 (Day 9)

    Measured as µM*h.

  4. Part B: The area under the NNC6022-0001 plasma concentration-time curve from time 0 to infinity (AUC0-∞) after a single dose

    Time frame: From pre-dose (Day 1) until visit 3 (Day 9)

    Measured as µM*h.

  5. Part B: The maximum observed plasma concentration (Cmax) of NNC6022-0001 after a single dose

    Time frame: From pre-dose (Day 1) until visit 3 (Day 9)

    Measured as µM.

  6. Part B: Proportion of administered dose recovered as unchanged drug in urine (Fe0-72h), calculated as Ae0-72hour/ dose

    Time frame: From dose (Day 1) until 72h post-dose

    Measured as proportion of dose.

  7. Part C: The area under the NNC6022-0001 plasma concentration-time curve from time 0 to tau (AUCtau) after the last dose

    Time frame: From pre-dose (Day 28) to tau after last dose (Day 29)

    Measured as µM*h.

  8. Part C: The maximum observed plasma concentration (Cmax) of NNC6022-0001 after last dose

    Time frame: From pre-dose (Day 28) until visit 3 (Day 35)

    Measured as µM.

  9. Part C: interleukin β (IL-1β) (ex vivo): ratio of plasma level at time tau after last dose to baseline

    Time frame: From pre-dose (Day 1) to tau after last dose (Day 29)

    Measured as ratio

  10. Part D: The area under the NNC6022-0001 plasma concentration-time curve from time 0 to infinity (AUC0-∞) after a single dose

    Time frame: From pre-dose (Day 1 or Day 8) to end of visit (Day 5 or Day 12)

    Measured as µM*h.

  11. Part D: The maximum observed plasma concentration (Cmax) of NNC6022-0001 after a single dose

    Time frame: From pre-dose (Day 1 or Day 8) to end of visit (Day 5 or Day 12)

    Measured as µM.

  12. Part D: Number of treatment emergent adverse events

    Time frame: From time of dosing (Day 1) to end of visit (Day 16)

    Measured as number of events.

  13. Part E: Ratio of plasma level at time tau after last dose to baseline (hsCRP)

    Time frame: From pre-dose (Day 1) to tau after last dose (Day 8)

    Measured as ratio.

  14. Part E: The area under the NNC6022-0001 plasma concentration-time curve from time 0 to tau (AUCtau) after last dose

    Time frame: From pre-dose (Day 7) to tau after last dose (Day 8)

    Measured as µM*h .

  15. Part E: The maximum observed plasma concentration (Cmax) of NNC6022 0001 after last dose

    Time frame: From pre-dose (Day 7) until visit 3 (Day 13)

    Measured as µM.

Study contacts

Contact information is provided by the study sponsor or research team.

Novo Nordisk

CONTACT

[email protected]

(+1) 866-867-7178

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 9, 2026
Registry last updated
Jul 9, 2026

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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