A Research Study to Compare How Much of the Medicine NNC0519-0130 is in the Blood of People With Overweight or Obesity Who Receive 2 Preparations of the Medicine

Investigation of Pharmacokinetics of 2 Different Formulations of NNC0519-0130 in Adult Participants With Overweight or Obesity

This study will look into a new study medicine called NNC0519-0130 to improve the treatment option for people living with excess body weight or type 2 diabetes or both. The purpose of this study is to compare the amount of NNC0519-0130 in the blood of participants who have excess body weight. The study comprises two parts and the participants will receive both preparations NNC0519-0130 B and NNC0519-0130 C, which treatment the participants get is decided by chance. The study will last for about 24 weeks.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Drug: NNC0519-0130 B; Drug: NNC0519-0130 C

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78209
      • ICON

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male or female of non-childbearing potential.
• Age 18-64 years (both inclusive) at the time of signing the informed consent.
• Body Mass Index (BMI) between 27.0 kilogram per square meter (kg/m^2) and 39.9 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 and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Exclusion Criteria:

• Any condition which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
• Glycated hemoglobin (HbA1c) greater than or equal to (≥) 6.5 % (48 millimoles per mole [mmol/mol]) at screening.
• Use of prescription medicinal products or nonprescription drugs, except routine vitamins, occasional use of acetaminophen, ibuprofen, acetylsalicylic acid, or topical medication (including eye drops for pupil dilation) not reaching systemic circulation, within 14 days before screening.
• Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1a: NNC0519-0130 C and NNC0519-0130 B; Participants will start treatment with formulation NNC0519-0130 C and receive a pre-determined dose escalation regimen of NNC0519-0130 B and NNC0519-0130 C.	Drug: NNC0519-0130 B; NNC0519-0130 B will be administered subcutaneously.; Drug: NNC0519-0130 C; NNC0519-0130 C will be administered subcutaneously.
Experimental: Part 1b: NNC0519-0130 B and NNC0519-0130 C; Participants will start treatment with formulation NNC0519-0130 B and receive a pre-determined dose escalation regimen of NNC0519-0130 B and NNC0519-0130 C.	Drug: NNC0519-0130 B; NNC0519-0130 B will be administered subcutaneously.; Drug: NNC0519-0130 C; NNC0519-0130 C will be administered subcutaneously.
Experimental: Part 2a: NNC0519-0130 B and NNC0519-0130 C; Participants will receive a pre-determined dose escalation regimen of NNC0519-0130 B in run-in period followed by treatment with NNC0519-0130 B then NNC0519-0130 C.	Drug: NNC0519-0130 B; NNC0519-0130 B will be administered subcutaneously.; Drug: NNC0519-0130 C; NNC0519-0130 C will be administered subcutaneously.
Experimental: Part 2b: NNC0519-0130 C and NNC0519-0130 B; Participants will receive a pre-determined dose escalation regimen of NNC0519-0130 B in run-in period followed by treatment with NNC0519-0130 C then NNC0519-0130 B.	Drug: NNC0519-0130 B; NNC0519-0130 B will be administered subcutaneously.; Drug: NNC0519-0130 C; NNC0519-0130 C will be administered subcutaneously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC,NNC0519-0130,SS: Area under the NNC0519-0130 plasma concentration-time curve during a dosing interval at steady state (SS)	Measured in hours*nanomoles per liter (h*nmol/L).	From pre-dose up to 7 days post-dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax,NNC0519-0130,SS: Maximum plasma concentration of NNC0519-0130 at steady state	Measured in nanomoles per liter (nmol/L).	From pre-dose up to 7 days post-dose
Number of adverse events	Measured in number of events.	From time of first dosing (day 1) until completion of the end of study visit (day 141/162)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2024
• Primary Completion (Actual): May 17, 2025
• Study Completion (Actual): May 31, 2025

Study Registration Dates

• First Submitted: October 13, 2024
• First Submitted That Met QC Criteria: October 13, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): November 25, 2025
• Last Update Submitted That Met QC Criteria: November 24, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity
• Other Study ID Numbers: NN9541-4919; U1111-1307-3788 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No