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
NCT ID: NCT06642571
Last Updated: 2025-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
46 participants
INTERVENTIONAL
2024-10-15
2025-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Part 1a: NNC0519-0130 C and NNC0519-0130 B
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.
NNC0519-0130 B
NNC0519-0130 B will be administered subcutaneously.
NNC0519-0130 C
NNC0519-0130 C will be administered subcutaneously.
Part 1b: NNC0519-0130 B and NNC0519-0130 C
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.
NNC0519-0130 B
NNC0519-0130 B will be administered subcutaneously.
NNC0519-0130 C
NNC0519-0130 C will be administered subcutaneously.
Part 2a: NNC0519-0130 B and NNC0519-0130 C
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.
NNC0519-0130 B
NNC0519-0130 B will be administered subcutaneously.
NNC0519-0130 C
NNC0519-0130 C will be administered subcutaneously.
Part 2b: NNC0519-0130 C and NNC0519-0130 B
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.
NNC0519-0130 B
NNC0519-0130 B will be administered subcutaneously.
NNC0519-0130 C
NNC0519-0130 C will be administered subcutaneously.
Interventions
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NNC0519-0130 B
NNC0519-0130 B will be administered subcutaneously.
NNC0519-0130 C
NNC0519-0130 C will be administered subcutaneously.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
64 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Transparency (dept. 2834)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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ICON
San Antonio, Texas, United States
Countries
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Other Identifiers
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U1111-1307-3788
Identifier Type: OTHER
Identifier Source: secondary_id
NN9541-4919
Identifier Type: -
Identifier Source: org_study_id
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