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NCT Number: NCT07797855

A Study to See How Safe a New Medicine (NNC0705-0002) is in Healthy People

This study is testing NNC0705-0002, a new medicine that is being developed for conditions where inflammation may contribute to heart and metabolic health problems. The purpose of this study is to assess the safety, tolerability, pharmacokinetics, target engagement, and metabolism of NNC0705-0002 after single and multiple doses in healthy adults. NNC0705-0002 or a placebo (a substance that looks like the study medicine but contains no active medicine), and the treatment they receive may be chosen by chance. NNC0705-0002 is a new medicine that is not yet approved for doctors to prescribe. Depending on the part of the study, participation may last for up to about 7 weeks, including screening, treatment, and follow-up visits.

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Key information

Conditions

Healthy Volunteers Cardiometabolic Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

ICON - location Groningen

Groningen, 9728 NZ, Netherlands

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Men or women of non-childbearing potential.
  • Age 18-55 years (both inclusive) at the time of signing the informed consent.
  • Body mass index (BMI) between 18.5 to 29.9 kilogram per square metre (kg/m^2) (both inclusive) at screening.
  • Body weight: greater than or equal to (≥) 50.0 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.

Exclusion criteria

  • Known or suspected hypersensitivity to study intervention(s) or related products.
  • Any condition, 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) greater than (>) upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) >ULN
  • Total bilirubin (TBL) >ULN
  • Creatinine >ULN
  • International normalised ratio (INR) >ULN
  • High-sensitivity C-reactive protein (hsCRP) greater than (>)5 milligram per liter (mg/L) (males) and >8 mg/L (females)
  • Use of prescription medicinal products or vaccines within 14 days before dosing 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 acetaminophen/paracetamol and/or nonsteroidal anti-inflammatory drugs at their labelled doses for mild pain; vitamins at their labelled doses.

Treatment and study plan

NNC0705-0002

Drug

Participants will receive oral capsule of NNC0705-0002.

Placebo

Drug

Participants will receive oral capsule of placebo matched to NNC0705-0002.

Primary outcomes

  1. Number of treatment emergent adverse events (TEAEs)

    Time frame: From time of dosing (day 1) to day 7

    Measured as number of events.

  2. Number of TEAEs

    Time frame: From time of dosing (day 1) to day 13

    Measured as number of events.

  3. AUC0-t, SD; the area under the NNC0705- 0002 plasma concentration-time curve from time 0 to last measurable plasma concentration after a single dose

    Time frame: From pre-dose (day 1 or day 10) to day 6 or day 15

    Measured as hour micromolar (h*μM).

  4. Total recovery of administered radiolabelled NNC0705- 0002-related material (sum urine and faeces)

    Time frame: From time of dosing (day 1) to no later than day 21

    Measured as percentage (%) of dose.

Secondary outcomes

  1. AUC0-∞, SD; the area under the NNC0705- 0002 plasma concentration-time curve from time 0 to infinity after a single dose

    Time frame: From pre-dose (day 1) to day 7

    Measured as h*μM.

  2. Cmax, SD; the maximum observed plasma concentration of NNC0705-0002 after a single dose

    Time frame: From pre-dose (day 1) to day 7

    Measured as micromolar (μM).

  3. AUCtau, MD; the area under the NNC0705- 0002 plasma concentration-time curve from time 0 to tau after the last dose

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

    Measured as h*μM.

  4. Cmax, MD; the maximum observed plasma concentration of NNC0705-0002 after last dose

    Time frame: From pre-dose (day 7) to day 13

    Measured as μM.

  5. AUC0-∞, SD; the area under the NNC0705- 0002 plasma concentration-time curve from time 0 to infinity after a single dose

    Time frame: From pre-dose (day 1 or day 10) to day 6 or day 15

    Measured as h*μM.

  6. Cmax, SD; the maximum observed plasma concentration of NNC0705-0002 after a single dose

    Time frame: From pre-dose (day 1 or day 10) to day 6 or day 15

    Measured as μM.

  7. Dose-normalised AUC0-∞, SD; the area under the NNC0705-0002 or radiolabelled NNC0705-0002-related material total radioactivity (TRA) plasma concentration-time curve from time 0 to infinity after a single dose divided by dose

    Time frame: From pre-dose (day 1) to day 17

    Measured as hour micromolar per milligram (h*μM/mg).

  8. Total amount of radiolabelled NNC0705-0002- related material excreted in urine

    Time frame: From pre-dose (day 1) to day 6

    Measured as % of dose.

  9. Total amount of radiolabelled NNC0705-0002- related material excreted in faeces

    Time frame: From pre-dose (day 1) to day 6

    Measured as % of dose.

  10. AUC0-∞,14C,SD; area under the plasma concentration-time curve of radiolabelled NNC0705-0002-related material (TRA) from time 0 to infinity after a single dose

    Time frame: From pre-dose (day 1) to day 9

    Measured as hundreds of nanomoles per litre (h*nmol/L).

  11. Number of TEAEs

    Time frame: From time of dosing (day 1) to day 17

    Measured as number of events.

  12. AUC0-∞,14C,SD; area under the plasma concentration-time curve of radiolabelled NNC0705-0002-related material (TRA) from time 0 to infinity after a single dose

    Time frame: From pre-dose (day 1) to no later than day 21

    Measured as h*nmol/L.

  13. Cmax,14C,SD: maximum observed plasma concentration of radiolabelled NNC0705-0002- related material (TRA) after a single dose

    Time frame: From pre-dose (day 1) to no later than day 21

    Measured as nanomole per litre (nmol/L).

  14. AUC0-∞,SD; area under the plasma concentration-time curve of NNC0705- 0002 from time 0 to infinity after a single dose

    Time frame: From pre-dose (day 1) to day 5

    Measured as h*nmol/L.

  15. Cmax,SD: maximum observed plasma concentration of NNC0705-0002 after a single dose

    Time frame: From pre-dose (day 1) to day 5

    Measured as nmol/L.

  16. Number of TEAEs

    Time frame: From time of dosing (day 1) to day 23

    Measured as number of events.

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

A First in Human Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, Target Engagement, and Absorption, Metabolism and Excretion of NNC0705-0002 Following Single and Multiple Oral Administrations of NNC0705-0002 in Healthy Adults

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 1, 2026
Registry last updated
Sep 1, 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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