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Completed

NCT Number: NCT06069895

Investigation of Safety, Tolerability and Pharmacokinetics of Multiple Doses of NNC0113-6856 in Healthy Participants, Including a Subset of Healthy Japanese Participants

NNC0113-6856 is a new medicine which may help participants with type 2 diabetes to improve blood sugar control. NNC0113-6856 is slowly converted in the body to semaglutide, a substance similar to a hormone (signaling substance) in the body. The main purpose of this study will be to evaluate the safety of different strengths of NNC0113-6856 when given as multiple administrations, and the amount of NNC0113-6856 in the blood will be measured as well as the amount of specific parts (including semaglutide). Participants will either get multiple doses of the new medicine NNC0113-6856 or multiple doses of placebo (a "dummy" medicine that looks like the new medicine but is without any active ingredient). Whether participants get the new medicine or placebo is decided by chance. The duration of the study could last up to 25 weeks.

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Key information

Conditions

Healthy Participants

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Profil Institut für Stoffwechselforschung GmbH

Neuss, 41460, Germany

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Male or female.
  • Age 18-55 years (both inclusive) at the time of signing the informed consent.
  • Body mass index (BMI) between 21.0 and 29.9 kilograms per meter square (kg/m^2) (both inclusive) at screening.

Additional for healthy Japanese participants:

  • First generation Japanese (Japanese born participants).

Exclusion criteria

  • HbA1c greater than or equal to (≥) 6.5 percent (%) (48 millimoles per mole [mmol/mol]) at screening.
  • Any of the below laboratory safety parameters at screening outside the below laboratory range, see "Log of laboratory ranges used for laboratory parameter exclusion criterion" for specific values:
  • Alanine Aminotransferase (ALT) greater than (>) upper normal limit (UNL) +10%
  • Aspartate aminotransferase (AST) > UNL+20%
  • Total bilirubin > UNL+20%
  • Creatinine > UNL+10%
  • International normalised ratio (INR) > UNL

Treatment and study plan

NNC0113-6856

Drug

NNC0113-6856 will be administered as oral tablets.

Placebo

Drug

NNC0113-6856 matching placebo will be administered as oral tablets.

Primary outcomes

  1. Number of adverse events (AEs)

    Time frame: From time of first dosing (day 1) until completion of the follow-up visit (day 148)

    Measured as number of events.

Secondary outcomes

  1. Part 1 Multiple ascending dose (MAD): AUCτ,sema,SS: area under the semaglutide plasma concentration-time curve during a dosing interval τ at steady state

    Time frame: From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106

    Measured in hours*nanomoles per liter (h*nmol/L).

  2. Part 1 (MAD): Cmax,sema,SS: maximum observed plasma concentration of semaglutide at steady state

    Time frame: From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106

    Measured in nanomoles per liter(nmol/L).

  3. Part 1 (MAD): AUCτ,6856,SS: area under the NNC0113-6856 plasma concentration-time curve during a dosing interval τ at steady state

    Time frame: From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106

    Measured in h*nmol/L.

  4. Part 1 (MAD): Cmax,6856,SS: maximum observed plasma concentration of NNC0113-6856 at steady state

    Time frame: From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106

    Measured in nmol/L.

  5. Part 1 (MAD): AUCτ,4768,SS: area under the NNC0113-4768 plasma concentration-time curve during a dosing interval τ at steady state

    Time frame: From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106

    Measured in h*nmol/L.

  6. Part 1 (MAD): Cmax,4768,SS: maximum observed plasma concentration of NNC0113-4768 at steady state

    Time frame: From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106

    Measured in nmol/L.

  7. Part 2 Dosing condition (DC): AUCτ,sema,SS: area under the semaglutide plasma concentration-time curve during a dosing interval τ at steady state

    Time frame: From 0 to 168 hours after fourth dosing with the same dose at days 50, 78 and 106

    Measured in h*nmol/L.

  8. Part 2 (DC): Cmax,sema,SS: maximum observed plasma concentration of semaglutide at steady state

    Time frame: From 0 to 168 hours after fourth dosing with the same dose at days 50, 78 and 106

    Measured in nmol/L.

  9. Part 2 (DC): AUCτ,6856,SS: area under the NNC0113-6856 plasma concentration-time curve during a dosing interval τ at steady state

    Time frame: From 0 to 168 hours after fourth dosing with the same dose at days 50, 78 and 106

    Measured in h*nmol/L.

  10. Part 2 (DC): Cmax,6856,SS: maximum observed plasma concentration of NNC0113-6856 at steady state

    Time frame: From 0 to 168 hours after fourth dosing with the same dose at days 50, 78 and 106

    Measured in nmol/L.

  11. Part 2 (DC): AUCτ,4768,SS: area under the NNC0113-4768 plasma concentration-time curve during a dosing interval τ at steady state

    Time frame: From 0 to 168 hours after fourth dosing with the same dose at days 50, 78 and 106

    Measured in h*nmol/L.

  12. Part 2 (DC): Cmax,4768,SS: maximum observed plasma concentration of NNC0113-4768 at steady state

    Time frame: From 0 to 168 hours after fourth dosing with the same dose at days 50, 78 and 106

    Measured in nmol/L.

  13. Part 3 Japanese (JP): AUCτ,sema,SS: area under the semaglutide plasma concentration-time curve during a dosing interval τ at steady state

    Time frame: From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106

    Measured in h*nmol/L.

  14. Part 3 (JP): Cmax,sema,SS: maximum observed plasma concentration of semaglutide at steady state

    Time frame: From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106

    Measured in nmol/L.

  15. Part 3 (JP): AUCτ,6856,SS: area under the NNC0113-6856 plasma concentration-time curve during a dosing interval τ at steady state

    Time frame: From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106

    Measured in h*nmol/L.

  16. Part 3 (JP): Cmax,6856,SS: maximum observed plasma concentration of NNC0113-6856 at steady state

    Time frame: From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106

    Measured in nmol/L.

  17. Part 3 (JP): AUCτ,4768,SS: area under the NNC0113-4768 plasma concentration-time curve during a dosing interval τ at steady state

    Time frame: From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106

    Measured in h*nmol/L.

  18. Part 3 (JP): Cmax,4768,SS: maximum observed plasma concentration of NNC0113-4768 at steady state

    Time frame: From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106

    Measured in nmol/L.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 6, 2023
Registry last updated
Jun 18, 2025

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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