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

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: NNC0650-0013 A; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06284798

2023-506134-79 (Other Identifier)

U1111-1291-7535 (Other Identifier)

NN9650-5027

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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11 participants in 3 patient groups, including a placebo group

NNC0650-0013: Subcutaneous dose

Experimental group

Description:

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

Treatment:

Drug: NNC0650-0013 A

Placebo

Placebo Comparator group

Description:

Participants will receive matching placebo to NNC0650-0013 subcutaneously.

Treatment:

Drug: Placebo

NNC0650-0013: Intravenous dose

Experimental group

Description:

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

Treatment:

Drug: NNC0650-0013 A