GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

A Research Study of How Safe a New Medicine Called NNC0519 0130 is and to Test Its Effect in People Living With Excess Body Weight With or Without Type 2 Diabetes

Investigation of the Safety, Tolerability, Pharmacokinetics and Efficacy of Subcutaneous Weekly Doses of NNC0519-0130 in Participants With Obesity and in Participants With Type 2 Diabetes With Either Overweight or Obesity

Lead sponsor

Novo Nordisk A/S

Asset

NNC0519-0130

Subcutaneous · GLP-1 / GIP dual

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criterion

—

Primary endpoint

•Treatment-emergent AEs (any)

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 IDNCT06567041

Org study IDNN9541-8116

Secondary ID2024-512719-28EU CT Number

Secondary IDU1111-1305-5164Universal Trial Number

Timeline

Milestones

Study start2024-08-07actual

Study first posted2024-08-22actual

Primary completion2025-12-10actual

Study completion2025-12-10actual

Last update posted2025-12-31actual

Assets

Investigational agents

NNC0519-0130

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age55 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.

•Male or female of non-childbearing potential.

•Age 18-55 years (both inclusive) at the time of signing the informed consent.

•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.

Participants with obesity only:

•Body mass index between 30.0 kilogram per meter square (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.

Participants with type 2 diabetes with either overweight or obesity:

•Body mass index between 27.0 kg/m^2 and 39.9kg/m^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.

•Diagnosed with type 2 diabetes mellitus greater than or equal to (≥) 180 days before screening.

•Glycated haemoglobin (HbA1c) in the range of 6.5 percentage (%) (inclusive) and 9.5% (inclusive).

Exclusion criteria

•Any condition, except T2D and hypertension, 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, gastrointestinal, endocrinological conditions (except diabetes mellitus and hypertension).

•Presence or history of cardiovascular disease including stable and unstable angina pectoris, myocardial infarction, transient ischaemic attack, stroke, cardiac decompensation, clinically significant arrhythmias or clinically significant conduction disorders.

•Participant is breastfeeding.

Participants with obesity only:

•HbA1c ≥ 6.5 % (48 millimoles per mol [mmol/mol]) at screening.

Participants with type 2 diabetes with either overweight or obesity:

•Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.

•Recurrent severe hypoglycaemia within the last year as judged by the investigator.

•Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire question 8.

Endpoints (5)

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

5 endpoints

Primary/protocol endpoint

Number of adverse events

Time frame:From time of first dosing (day 1) until completion of the end of study visit (day 274/253)

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Change in 12-lead electrocardiogram, Individual-specific heart rate corrected QT interval (QTcI)

Time frame:From baseline (day - 1) until completion of the end of study visit (day 274/253)

change from baseline, descriptive

Secondary/protocol endpoint

Change in 12-lead electrocardiogram, Fridericia heart rate corrected QT interval (QTcF)

Time frame:From baseline (day - 1) until completion of the end of study visit (day 274/253)

change from baseline, descriptive

Secondary/protocol endpoint

Area under the NNC0519-0130 plasma concentration-time curve in steady state

Time frame:From pre-dose until 7 days post-dose, for third and last doses in the maintenance period

Plasma concentration (steady state)

concentration, descriptive

Secondary/protocol endpoint

Maximum plasma concentration of NNC0519-0130 in steady state

Time frame:From pre-dose until 7 days post-dose, for third and last doses in the maintenance period

Plasma concentration (steady state)

concentration, descriptive

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.