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

Phase 1

Not yet recruiting

• Conditions: Diabetes Mellitus, Type 2; Obesity
• Interventions: Drug: NNC0519-0130; Drug: Placebo

• Registration Number: NCT07004322
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study Start: 2025-05-26
• Study First Submitted: 2025-05-26
• Study First Submitted QC: 2025-05-26
• Last Update Submitted: 2025-05-26
• Study First Posted: 2025-06-04
• Last Update Posted: 2025-06-04
• Primary Completion: 2026-04-07
• Study Completion: 2026-04-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NNC0519-0130	NNC0519-0130	Participants will receive once weekly subcutaneous (s.c.) administration of NNC0519-0130 in dose escalation manner.
Placebo	Placebo	Participants will receive once weekly subcutaneous administration of placebo matched to NNC0519-0130.

Primary Outcome Measures

Name	Time	Method
AUC, NNC0519-0130, SS: Area under the NNC0519-0130 plasma concentration-time curve after the last dose in each treatment period	From pre-dose up to 7 days post-dose	Measured in hours\*nanomoles per liter (h\*nmol/L).

Secondary Outcome Measures

Name	Time	Method
Cmax, NNC0519-0130, SS: Maximum plasma concentration of NNC0519-0130 after the last dose in each treatment period	From pre-dose up to 7 days post-dose	Measured in nanomoles per liter (nmol/L).
t½, NNC0519-0130, SS: Terminal half-life of NNC0519-0130 after the last dose	From pre-dose until completion of the follow-up visit (day 162)	Measured in hours (h).
Number of treatment emergent adverse events (TEAEs)	From time of first dosing (day 1) until completion of the end of study visit (day 162)	Measured in number of events.

Trial Locations

Locations (1)

Peking University Third Hospital, Northern branch-Phase I; 🇨🇳 Beijing, Beijing, China