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NCT Number: NCT06284798

A Research Study of a New Medicine (NNC0650-0013) in Healthy Men

This study is testing a new study medicine which may be used to treat people with type 2 diabetes. NNC0650-0013 is a new medicine, which cannot be prescribed by doctors. The purpose of the study is to see if the new study medicine is safe, and how it works in participants body. Participants will get a single dose of the study medicine either as injection(s) under the skin or into a vein. The injection will be given by the study staff. If participants are chosen to get the study medicine as injections under the skin, participants will either get NNC0650-0013 or placebo (a "dummy medicine" without any active ingredients). Which treatment participants get is decided by chance. Participants will be required to fast overnight 3 times during the study. The study will last between 11 and 17 weeks.

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Key information

Conditions

Healthy Participants

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Profil Institut für Stoffwechselforschung GmbH

Neuss, 41460, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male.
  • Age 18-55 years (both inclusive) at the time of signing the informed consent.
  • Body mass index between 24.0 and 29.9 kilogram per meter square (kg/m^2) (both inclusive) at screening.
  • Considered to be otherwise 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

  • Any disorder, unwillingness or inability, which, in the investigator's opinion, might jeopardise the participant's safety or compliance with the protocol.
  • Glycated haemoglobin (HbA1c) greater than or equal to 6.5 percent (48 millimoles per mole (mmol/mol)) at screening.

Treatment and study plan

NNC0650-0013 A

Drug

NNC0650-0013 will be administered subcutaneously or intravenously.

Placebo

Drug

Subcutaneous administration.

Primary outcomes

  1. S.C. Cohort: Number of treatment emergent adverse events (TEAEs)

    Time frame: From time of dosing (day 1) until completion of the follow-up visit (day 75)

    Measured as number of events.

Secondary outcomes

  1. S.C. Cohort: AUC0-∞,0188,SD: Area under the NNC0519-0188 plasma concentration time curve from time 0 to infinity after a single dose

    Time frame: From pre-dose (day 1) until completion of the follow up visit (day 75)

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

  2. S.C. Cohort: Cmax,0188,SD: Maximum plasma concentration of NNC0519-0188 after a single dose

    Time frame: From pre-dose (day 1) until completion of the follow-up visit (day 75)

    Measured as nanomoles per liter (nmol/L).

  3. S.C. Cohort: AUC0-∞,0013,SD: Area under the NNC0650-0013 plasma concentration-time curve from time 0 to infinity after a single dose

    Time frame: From pre-dose (day 1) until completion of the follow-up visit (day 75)

    Measured as h*nmol/L.

  4. S.C. Cohort: Cmax,0013,SD: Maximum observed plasma concentration of NNC0650-0013 after a single dose

    Time frame: From pre-dose (day 1) until completion of the follow-up visit (day 75)

    Measured as nanomoles per liter (nmol/L).

  5. S.C. Cohort: AUC0-∞,0031,SD: Area under the NNC0650-0031plasma concentration time curve from time 0 to infinity after a single dose

    Time frame: From pre-dose (day 1) until completion of the follow-up visit (day 75)

    Measured as h*nmol/L.

  6. S.C. Cohort: Cmax,0031,SD: Maximum observed plasma concentration of NNC0650-0031 after a single dose

    Time frame: From pre-dose (day 1) until completion of the follow-up visit (day 75)

    Measured as nanomoles per liter (nmol/L).

  7. I.V. Cohort: AUC0-∞,0188,SD: Area under the NNC0519-0188 plasma concentration-time curve from time 0 to infinity after a single dose

    Time frame: From pre-dose (day 1) until completion of the follow-up visit (day 75)

    Measured as h*nmol/L.

  8. I.V. Cohort: AUC0-∞,0013,SD: Area under the NNC0650-0013 plasma concentration-time curve from time 0 to infinity after a single dose

    Time frame: From pre-dose (day 1) until completion of the follow-up visit (day 75)

    Measured as h*nmol/L.

  9. I.V. Cohort: AUC0-∞,0031,SD: Area under the NNC0650-0031 plasma concentration-time curve from time 0 to infinity after a single dose

    Time frame: From pre-dose (day 1) until completion of the follow-up visit (day 75)

    Measured as h*nmol/L.

  10. S.C. and I.V. Cohort: AUC0-∞,0013,SD/dose: Area under the NNC0650-0013 plasma concentration-time curve from time 0 to infinity after a single dose divided by the dose administered

    Time frame: From pre-dose (day1) until completion of the follow-up visit (day 75)

    Measured as hours nanomoles per milligram (h*nmol/mg).

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A First Human Dose Study Investigating Safety, Tolerability, and Pharmacokinetics of Subcutaneous Single Ascending Doses of NNC0650-0013 in Healthy Male Participants

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 29, 2024
Registry last updated
Dec 5, 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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