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CompletedNCT06718998Updated Apr 3, 2026

A Research Study Comparing Different Ways of Increasing the Dose of NNC0519-0130 in Participants With Overweight or Obesity

A Phase 1 interventional study of NNC0519-0130 in Obesity, sponsored by Novo Nordisk A/S. Completed at 1 site in Austria. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-04-03.

Sponsored by Novo Nordisk A/S · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
134
Allocation
Randomized
Ages
18 Years to 64 Years
Sex
All
01

Study summary

Novo Nordisk is developing a new study medicine NNC0519-0130 to improve the treatment options for people living with type 2 diabetes and people with excess body weight. This study will look at the safety and tolerability of NNC0519-0130. The purpose of this study is to investigate if different ways of increasing the dose of NNC0519-0130 in the main and extension phase can lessen the side effects that may occur when people take NNC0519-0130. There will be four different ways of increasing the dose of the study medicine and participants will get assigned to one of these - which one the participants get is decided by chance. This study will last for about 24 weeks.

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Conditions studied

  • Obesity

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03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's enrollment of 134 is above the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Female of non-childbearing potential, or male.
  • Age 18-64 years (both inclusive) at the time of signing the informed consent.
  • Body mass index (BMI) between 27.0 and 44.9 kilogram per square meter (kg/m\^2) (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
  • Considered to be otherwise 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.

Exclusion criteria

Exclusion criteria:

  • Any disorder, unwillingness or inability which in the investigator's opinion, might jeopardise the participant's safety or compliance with the protocol.
  • Glycated haemoglobin (HbA1c) greater than or equal to (>=) 6.5 percentage (48 millimoles per mole [mmol/mol]) at screening.
  • Use of prescription medicinal products or non-prescription drugs, except routine vitamins, occasional use of paracetamol, NSAIDs (nonsteroidal anti-inflammatory drugs), acetylsalicylic acid, or topical medication 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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
134 participants (actual)

Study arms

  • Experimental
    Arm 1: NNC0519-0130

    Participants will receive once-weekly subcutaneous (s.c) injections of NNC0519-0130 following a predetermined dose escalation regimen 1 in the main and extension phase.

    Drug: NNC0519-0130

  • Experimental
    Arm 2: NNC0519-0130

    Participants will receive once-weekly s.c injections of NNC0519-0130 following a predetermined dose escalation regimen 2 in the main phase and extension phase.

    Drug: NNC0519-0130

  • Experimental
    Arm 3: NNC0519-0130

    Participants will receive twice-weekly s.c injections of NNC0519-0130 following a predetermined dose escalation regimen 3 in the main phase and extension phase.

    Drug: NNC0519-0130

  • Experimental
    Arm 4: NNC0519-0130

    Participants will receive once-weekly s.c injections of NNC0519-0130 following a predetermined dose escalation regimen 4 in the main and extension phase.

    Drug: NNC0519-0130

Interventions

  • DrugNNC0519-0130

    Participants will receive once-weekly or twice weekly NNC0519-0130 subcutaneously.

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What researchers measure

Primary outcomes

  1. Number of Adverse Events (AEs)

    Measured as number of events.

    Time frame: From randomisation (week 0) to week 18

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Study locations

1 site
  • Medical University of Graz
    Graz, 8010, Austria
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References and documents

Individual participant data

Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06718998
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Dec 5, 2024
Start date
Nov 20, 2024
Primary completion
Jan 12, 2026
Completion
Jan 12, 2026
Last update
Apr 3, 2026

Study contacts

Clinical Transparency (dept. 2834)
study director · Novo Nordisk A/S

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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