Clinical trial NCT07004322: A Research Study of the New Medicine NNC0519-0130 in Male Chinese Participants Living With Excess Body Weight
Official title: Investigation of Pharmacokinetics, Safety and Tolerability of Multiple Subcutaneous Doses of NNC0519-0130 in Male Chinese Participants With Overweight or Obesity
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 2
Obesity
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2025-06-04
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: AUC, NNC0519-0130, SS: Area under the NNC0519-0130 plasma concentration-time curve after the last dose in each treatment period
timeFrame: From pre-dose up to 7 days post-dose
Secondary outcomes:
measure: Cmax, NNC0519-0130, SS: Maximum plasma concentration of NNC0519-0130 after the last dose in each treatment period
timeFrame: From pre-dose up to 7 days post-dose
measure: t½, NNC0519-0130, SS: Terminal half-life of NNC0519-0130 after the last dose
timeFrame: From pre-dose until completion of the follow-up visit (day 162)
measure: Number of treatment emergent adverse events (TEAEs)
timeFrame: From time of first dosing (day 1) until completion of the end of study visit (day 162)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital, Northern branch-Phase I
state: Beijing
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References: