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

NCT07004322 | Completed Phase 1

• 2 other identifiers: NN9541-4918U1111-1283-0622
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

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

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

  From pre-dose up to 7 days post-dose

Secondary Outcomes (3)

• 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

• 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)

• Number of treatment emergent adverse events (TEAEs)

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

Study Arms (2)

NNC0519-0130

EXPERIMENTAL

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

Drug: NNC0519-0130

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

NNC0519-0130 DRUG

NNC0519-0130 will be administered subcutaneously.

NNC0519-0130

Placebo DRUG

Placebo matched to NNC0519-0130 will be administered subcutaneously.

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Peking University Third Hospital, Northern Branch-Phase I

Beijing, Beijing Municipality, 100089, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2025
• First Posted: June 4, 2025
• Study Start: May 26, 2025
• Primary Completion: January 28, 2026
• Study Completion: January 28, 2026
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)