A Research Study of the New Medicine NNC0519-0130 in Male Chinese Participants Living With Excess Body Weight

Novo Nordisk

Status and phase: Enrolling; Phase 1

Conditions: Obesity; Diabetes Mellitus, Type 2

Treatments: Drug: Placebo; Drug: NNC0519-0130

Study type: Interventional

Funder types: Industry

Identifiers

NCT07004322

U1111-1283-0622 (Other Identifier)

NN9541-4918

Details and patient eligibility

About

Novo Nordisk is developing a new study medicine NNC0519-0130 to improve the treatment options for people living with type 2 diabetes and excess body weight. In this study, the concentration of NNC0519-0130 in the blood will be measured and its safety will be evaluated. The participants will either get NNC0519-0130 or placebo (a "dummy" substance), which treatment the participants get is decided by chance. This study will test up to 7 different doses of NNC0519-0130 and will last for about 28 weeks.

Enrollment: 20 estimated patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male Chinese participant.
• Body Mass Index (BMI) between 24.0 and 39.9 kilogram per square meter (kg/m^2) (both inclusive) at screening. 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.

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.
• Glycated haemoglobin (HbA1c) greater than or equal to (≥) 6.5 percentage (%) (48 millimoles per mole [mmol/mol]) at screening.
• Use of prescription medicinal products or non-prescription drugs (including Chinese traditional medicine or local medicine) within 14 days before screening, except routine vitamins, occasional use of paracetamol, ibuprofen, acetylsalicylic acid (ASA), domperidone or topical medication.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups, including a placebo group

NNC0519-0130

Experimental group

Description:

Participants will receive once weekly subcutaneous (s.c.) administration of NNC0519-0130 in dose escalation manner.

Treatment:

Drug: NNC0519-0130

Placebo

Placebo Comparator group

Description:

Participants will receive once weekly subcutaneous administration of placebo matched to NNC0519-0130.

Treatment:

Drug: Placebo