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NCT Number: NCT07004322

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Body Weight Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Peking University Third Hospital, Northern Branch-Phase I

Beijing, Beijing Municipality, 100089, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NNC0519-0130

Drug

NNC0519-0130 will be administered subcutaneously.

Placebo

Drug

Placebo matched to NNC0519-0130 will be administered subcutaneously.

Primary outcomes

  1. AUC, NNC0519-0130, SS: Area under the NNC0519-0130 plasma concentration-time curve after the last dose in each treatment period

    Time frame: From pre-dose up to 7 days post-dose

    Measured in hours*nanomoles per liter (h*nmol/L).

Secondary outcomes

  1. Cmax, NNC0519-0130, SS: Maximum plasma concentration of NNC0519-0130 after the last dose in each treatment period

    Time frame: From pre-dose up to 7 days post-dose

    Measured in nanomoles per liter (nmol/L).

  2. t½, NNC0519-0130, SS: Terminal half-life of NNC0519-0130 after the last dose

    Time frame: From pre-dose until completion of the follow-up visit (day 162)

    Measured in hours (h).

  3. Number of treatment emergent adverse events (TEAEs)

    Time frame: From time of first dosing (day 1) until completion of the end of study visit (day 162)

    Measured in number of events.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Investigation of Pharmacokinetics, Safety and Tolerability of Multiple Subcutaneous Doses of NNC0519-0130 in Male Chinese Participants With Overweight or Obesity

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 4, 2025
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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