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CompletedPhase 1

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

Lead sponsor

Novo Nordisk A/S

Asset

NNC0519-0130

Subcutaneous · GLP-1 / GIP dual

Listed sites

1

Recruiting sites

Enrollment

46

actual

Study population

Obesity / overweight

Key I/E criterion

Primary endpoint

AUC of NNC0519-0130 during a dosing interval at steady state (SS)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06642571
Org study IDNN9541-4919
Secondary IDU1111-1307-3788World Health Organization (WHO)

Timeline

Milestones

Study first posted2024-10-15actual
Study start2024-10-15actual
Primary completion2025-05-17actual
Study completion2025-05-31actual
Last update posted2025-11-25actual

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age64 Years
SexAll
Healthy volunteersNot accepted

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.

Endpoints (3)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

3 endpoints
Primary/protocol endpoint

AUC,NNC0519-0130,SS: Area under the NNC0519-0130 plasma concentration-time curve during a dosing interval at steady state (SS)

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

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

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

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

Cmax

concentration, descriptive

Secondary/protocol endpoint

Number of adverse events

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

Treatment-emergent AEs (any)

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.