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

NCT06284798 | Completed Phase 1

• 3 other identifiers: NN9650-50272023-506134-79U1111-1291-7535
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (1)

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

  Measured as number of events.

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

Secondary Outcomes (10)

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

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

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

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

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

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

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

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

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

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

Study Arms (3)

NNC0650-0013: Subcutaneous dose

EXPERIMENTAL

Participants will receive NNC0650-0013 subcutaneously in an ascending dose manner.

Drug: NNC0650-0013 A

Placebo

PLACEBO COMPARATOR

Participants will receive matching placebo to NNC0650-0013 subcutaneously.

Drug: Placebo

NNC0650-0013: Intravenous dose

EXPERIMENTAL

Participants will receive NNC0650-0013 in an ascending dose manner intravenously.

Drug: NNC0650-0013 A

Interventions

NNC0650-0013 A DRUG

NNC0650-0013 will be administered subcutaneously or intravenously.

NNC0650-0013: Intravenous dose; NNC0650-0013: Subcutaneous dose

Placebo DRUG

Subcutaneous administration.

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Profil Institut für Stoffwechselforschung GmbH

Neuss, 41460, Germany

Location

Study Officials

• Clinical Transparency' (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: February 29, 2024
• Study Start: January 29, 2024
• Primary Completion: July 25, 2024
• Study Completion: July 25, 2024
• Last Updated: December 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)