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

Phase 1

Completed

• Conditions: Healthy Participants
• Interventions: Drug: NNC0650-0013 A; Drug: Placebo

• Registration Number: NCT06284798
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-29
• Study First Submitted: 2024-02-22
• Study First Submitted QC: 2024-02-22
• Study First Posted: 2024-02-29
• Primary Completion: 2024-07-25
• Study Completion: 2024-07-25
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-18
• Last Update Posted: 2024-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 11

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
NNC0650-0013: Intravenous dose	NNC0650-0013 A	Participants will receive NNC0650-0013 in an ascending dose manner intravenously.
NNC0650-0013: Subcutaneous dose	NNC0650-0013 A	Participants will receive NNC0650-0013 subcutaneously in an ascending dose manner.
Placebo	Placebo	Participants will receive matching placebo to NNC0650-0013 subcutaneously.

Primary Outcome Measures

Name	Time	Method
S.C. Cohort: Number of treatment emergent adverse events (TEAEs)	From time of dosing (day 1) until completion of the follow-up visit (day 75)	Measured as number of events.

Secondary Outcome Measures

Name	Time	Method
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)	Measured as h\*nmol/L.
S.C. Cohort: Cmax,0031,SD: Maximum observed plasma concentration of NNC0650-0031 after a single dose	From pre-dose (day 1) until completion of the follow-up visit (day 75)	Measured as nanomoles per liter (nmol/L).
I.V. Cohort: AUC0-∞,0031,SD: Area under the NNC0650-0031 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)	Measured as h\*nmol/L.
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)	Measured as h\*nmol/L.
I.V. 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)	Measured as h\*nmol/L.
I.V. 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)	Measured as h\*nmol/L.
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)	Measured as hours nanomoles per liter (h\*nmol/L).
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)	Measured as nanomoles per liter (nmol/L).
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)	Measured as nanomoles per liter (nmol/L).
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	From pre-dose (day1) until completion of the follow-up visit (day 75)	Measured as hours nanomoles per milligram (h\*nmol/mg).

Trial Locations

Locations (1)

Profil Institut für Stoffwechselforschung GmbH; 🇩🇪 Neuss, Germany