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

NCT ID: NCT06284798

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-29
• Study Completion Date: 2024-07-25

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

NNC0650-0013: Subcutaneous dose

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

Group Type: EXPERIMENTAL

NNC0650-0013 A

Intervention Type: DRUG

NNC0650-0013 will be administered subcutaneously or intravenously.

Placebo

Participants will receive matching placebo to NNC0650-0013 subcutaneously.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Subcutaneous administration.

NNC0650-0013: Intravenous dose

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

Group Type: EXPERIMENTAL

NNC0650-0013 A

Intervention Type: DRUG

NNC0650-0013 will be administered subcutaneously or intravenously.

Interventions

NNC0650-0013 A

NNC0650-0013 will be administered subcutaneously or intravenously.

Intervention Type: DRUG

Placebo

Subcutaneous administration.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Transparency' (dept. 2834)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Profil Institut für Stoffwechselforschung GmbH

Neuss, , Germany

Countries

Germany

Other Identifiers

2023-506134-79

Identifier Type: OTHER

Identifier Source: secondary_id

U1111-1291-7535

Identifier Type: OTHER

Identifier Source: secondary_id

NN9650-5027

Identifier Type: -

Identifier Source: org_study_id