GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

A Research Study of a New Medicine NNC0519-0130 in Healthy People, People With High Body Weight and People With Type 2 Diabetes.

Investigation of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Subcutaneous Doses of NNC0519-0130 in Healthy Participants and Multiple Subcutaneous and Oral Doses of NNC0519-0130 in Participants With Overweight or Obesity and Participants With Type 2 Diabetes

Lead sponsor

Novo Nordisk A/S

Asset

NNC0519-0130

Subcutaneous · GLP-1 / GIP dual

Listed sites

Recruiting sites

—

Enrollment

161

actual

Study population

Healthy volunteers, Obesity / overweight, Type 2 diabetes

Key I/E criterion

•Healthy volunteers

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 IDNCT05363774

Org study IDNN9541-4842

Secondary ID2021-004856-41

Secondary IDU1111-1267-4254World Health Organization (WHO)

Timeline

Milestones

Study start2022-04-20actual

Study first posted2022-05-06actual

Primary completion2024-04-02actual

Study completion2024-04-02actual

Last update posted2025-12-31actual

Assets

Investigational agents

NNC0519-0130

Study populations

Who this study enrolls

Healthy volunteersObesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age64 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Single ascending dose (SAD) part:

•Male aged 18-55 years (both inclusive) at screening

•Body mass index between 18.5 kilogram per meter square (kg/m^2) and 27.0 kg/m^2 (both inclusive) at screening

•Considered to be generally healthy 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

•Multiple ascending dose (MAD) part (MAD QD and MAD QW):

•Male aged 18-55 years (both inclusive) at screening

•Body mass index between 25.0 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

•Type 2 diabetes (T2D) part:

•Female of non-childbearing potential or male aged 18-64 years (both inclusive) at screening

•Body mass index between 25.0 kg/m^2 and 39.9 kg/m^2 (both inclusive) at screening

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

•Treatment naive to antidiabetic drugs or on a stable daily dose(s) of metformin therapy (any metformin formulation any dose) greater than or equal to (>=) 60 days before screening

•Insulin naive. However, short-term insulin treatment for a maximum of 14 days before screening is allowed, as is prior insulin treatment for gestational diabetes

•HbA1c in the range of 6.5% (inclusive) and 9.5% (inclusive)

Exclusion criteria

•Single ascending dose (SAD) part:

•Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol

•Glycosylated haemoglobin (HbA1c) greater than or equal to (≥) 6.5 % (48 millimoles per mole (mmol/mol)) at screening

•Use of prescription medicinal products or non-prescription drugs, except routine vitamins, occasional use of paracetamol, ibuprofen, acetylsalicylic acid, and domperidon, or topical medication not reaching systemic circulation, within 14 days before screening

•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

•HbA1c greater than or equal to (≥) 6.5 % (48 mmol/mol) at screening

•Multiple ascending dose (MAD) part (MAD QD and MAD QW):

•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

•HbA1c greater than or equal to (≥) 6.5 % (48 mmol/mol) at screening

•Type 2 diabetes (T2D) part:

•Any disorder, except for conditions associated with T2D, 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 conditions associated with diabetes mellitus)

•Current treatment with systemically effective corticosteroids, monoamine oxidase (MAO) inhibitors, systemic non-selective beta-blockers, growth hormone, non-routine vitamins or herbal products

•Current treatment with selected oral medication with a narrow therapeutic window, such as warfarin, digoxin, tricyclic antidepressants, lithium, aminophylline, theophylline and anticonvulsants

Endpoints (13)

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

13 endpoints

Primary/protocol endpoint

Number of treatment emergent adverse events (TEAE) in single ascending dose (SAD) part

Time frame:From time of dosing (day 1) until completion of the follow-up visit (assessed up to 22 days)

Treatment-emergent AEs (any)

event count, event

Primary/protocol endpoint

Number of treatment emergent adverse events (TEAE) in the Multiple ascending dose with daily dosing (MAD QD) subcutaneous cohort

Time frame:From time of dosing (day 1) until completion of the follow-up visit (assessed up to 133 days)

Treatment-emergent AEs (any)

event count, event

Primary/protocol endpoint

Number of treatment emergent adverse events (TEAE) in MAD QW s.c. cohort

Time frame:From time of first dosing (day 1) until completion of the follow-up visit (assessed up to 133 days)

Treatment-emergent AEs (any)

event count, event

Primary/protocol endpoint

Number of treatment emergent adverse events (TEAE) in T2D QW cohort

Time frame:From time of dosing (day 1) until completion of the follow-up visit (assessed up to 133 days)

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

AUC0-∞,NNC0519-0130,SD: Area under the NNC0519-0130 plasma concentration-time curve from time 0 (time of dosing) to infinity after a single dose

Time frame:From pre-dose (day 1) until completion of the follow-up visit (assessed up to 22 days)

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Cmax,NNC0519-0130,SD: Maximum plasma concentration of NNC0519-0130 after a single dose

Time frame:From pre-dose (day 1) until completion of the follow-up visit (assessed up to 22 days)

Cmax

concentration, descriptive

Secondary/protocol endpoint

Number of treatment emergent adverse events (TEAE) in the MAD QD oral cohort

Time frame:From time of dosing (day 1) until completion of the follow-up visit (assessed up to 112 days)

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

AUC0-24h,NNC0519-0130,SS: Area under the NNC0519-0130 plasma concentration-time curve after the last dose in each treatment period in MAD QD part

Time frame:From pre-dose (last dose in each treatment period) until 24 hours post-dose

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Cmax,NNC0519-0130,SS: Maximum plasma concentration of NNC0519-0130 after the last dose in each treatment period in MAD QD part

Time frame:From pre-dose (last dose in each treatment period) until 24 hours postdose

Cmax

concentration, descriptive

Secondary/protocol endpoint

AUC0-168h,NNC0519-0130,MD: Area under the NNC0519-0130 plasma concentration-time curve after the last dose in T2D QW cohort

Time frame:From pre-dose (last dose) until 168 hours post-dose

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Cmax,NNC0519-0130,MD: Maximum plasma concentration of NNC0519-0130 after the last dose in T2D QW cohort

Time frame:From pre-dose (last dose) until 168 hours post-dose

Cmax

concentration, descriptive

Secondary/protocol endpoint

AUC0-168h,NNC0519-0130,SS: Area under the NNC0519-0130 plasma concentration-time curve after the last dose in each treatment period in the MAD QW s.c. cohort

Time frame:From pre-dose (last dose in each treatment period) until 168 hours post-dose

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Cmax,NNC0519-0130,SS: Maximum plasma concentration of NNC0519-0130 after the last dose in each treatment period in the MAD QW s.c. cohort

Time frame:From pre-dose (last dose in each treatment period) until 168 hours post-dose

Cmax

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.