A Research Study of a New Medicine NNC0519-0130 in Japanese and Non-Japanese Men

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Placebo; Drug: NNC0519-0130

Study type: Interventional

Funder types: Industry

Identifiers

NCT05870670

NN9541-4921

U1111-1283-0710 (Other Identifier)

Details and patient eligibility

About

NNC0519-0130 is a new medicine which may possibly help participants with type 2 diabetes. This study, will look into how safe the new medicine NNC0519-0130 is, and we will measure its concentrations in the blood and look at its effects. This study will last for a maximum of 22 weeks and Japanese and Non-Japanese male participants will be included.

Enrollment: 22 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Body mass index (BMI) between 23.0 kilogram per meter square (kg/m^2) and 39.9 kg/m^2 (both inclusive) at screening with a minimum weight of 50 kilogram (kg). Overweight should be due to excess adipose tissue, as judged by the investigator.
• Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator.
• For Japanese participants: Both parents of Japanese descent.
• For non-Japanese participants: Both parents of Caucasian descent.

Exclusion criteria

• Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
• Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions.
• Glycosylated haemglobin (HbA1c) greater than or equal to 6.5 percent (48 millimoles per mole [mmol/mol]) at screening.
• Use of prescription medicinal products or non-prescription drugs, except routine vitamins, occasional use of paracetamol, ibuprofen, acetylsalicylic acid (ASA), and domperidon, or topical medication not reaching systemic circulation, within 14 days before screening.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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22 participants in 2 patient groups, including a placebo group

NNC0519-0130

Experimental group

Description:

Escalating multiple doses of NNC0519-0130 administered subcutaneously.

Treatment:

Drug: NNC0519-0130

Placebo

Placebo Comparator group

Description:

Escalating multiple doses of NNC0519-0130 matching placebo administered subcutaneously.

Treatment:

Drug: Placebo