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

NCT06642571 | Completed Phase 1 FDA Drug

• 2 other identifiers: NN9541-4919U1111-1307-3788
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Cmax,NNC0519-0130,SS: Maximum plasma concentration of NNC0519-0130 at steady state

  From pre-dose up to 7 days post-dose

• Number of adverse events

  From time of first dosing (day 1) until completion of the end of study visit (day 141/162)

Study Arms (4)

Part 1a: NNC0519-0130 C and NNC0519-0130 B

EXPERIMENTAL

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; Drug: NNC0519-0130 C

Part 1b: NNC0519-0130 B and NNC0519-0130 C

EXPERIMENTAL

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; Drug: NNC0519-0130 C

Part 2a: NNC0519-0130 B and NNC0519-0130 C

EXPERIMENTAL

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; Drug: NNC0519-0130 C

Part 2b: NNC0519-0130 C and NNC0519-0130 B

EXPERIMENTAL

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; Drug: NNC0519-0130 C

Interventions

NNC0519-0130 B DRUG

NNC0519-0130 B will be administered subcutaneously.

Part 1a: NNC0519-0130 C and NNC0519-0130 B; Part 1b: NNC0519-0130 B and NNC0519-0130 C; Part 2a: NNC0519-0130 B and NNC0519-0130 C; Part 2b: NNC0519-0130 C and NNC0519-0130 B

NNC0519-0130 C DRUG

NNC0519-0130 C will be administered subcutaneously.

Part 1a: NNC0519-0130 C and NNC0519-0130 B; Part 1b: NNC0519-0130 B and NNC0519-0130 C; Part 2a: NNC0519-0130 B and NNC0519-0130 C; Part 2b: NNC0519-0130 C and NNC0519-0130 B

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

ICON

San Antonio, Texas, 78209, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; 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: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2024
• First Posted: October 15, 2024
• Study Start: October 15, 2024
• Primary Completion: May 17, 2025
• Study Completion: May 31, 2025
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)