| Trial ID: | L3590 |
| Source ID: | NCT04259801
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| Associated Drug: |
Nnc0480-0389
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| Title: |
First Research Study to Look at How Two Medicines, NNC0480-0389 and Semaglutide, Work Together in Healthy People, in People With High Body Weight and in People With Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
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| Results: |
|
| Conditions: |
Healthy Volunteers|Overweight|Obesity|Diabetes Mellitus, Type 2
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| Interventions: |
DRUG: NNC0480-0389|DRUG: Semaglutide|DRUG: Placebo (NNC0480-0389)|DRUG: Placebo (semaglutide)
|
| Outcome Measures: |
Primary: Number of treatment emergent adverse events (TEAE) in Part 1, Number of events, From time of dosing (day 1) until completion of follow-up visit (day 71)|Number of treatment emergent adverse events (TEAE) in Part 2, Number of events, From first combination dosing (day 57) until completion of follow-up visit (day 148) | Secondary: Area under the NNC0480-0389 plasma concentration-time curve from time, h∙nmol/L, From baseline (day 1) to post treatment follow-up (day 71)|Maximum plasma concentration of NNC0480-0389 after administration of a single dose, nmol/L, From baseline (day 1) to post treatment follow-up (day 71)|Area under the semaglutide plasma concentration time curve from time of dosing to infinity after administration of a single dose, h∙nmol/L, From baseline (day 1) to post treatment follow-up (day 71)|The maximum concentration of semaglutide after administration of a single dose, nmol/L, From baseline (day 1) to post treatment follow-up (day 71)|Area under the NNC0480-0389 plasma concentration-time curve from 0 to 168 hours after administration of the 4th dose of NNC0480-0389 in week 12, h∙nmol/L, From administration of dose in week 12 (day 78) to day 85|Maximum plasma concentration of NNC0480-0389 after administration of the 4th dose of NNC0480-0389 in week 12, nmol/L, From administration of dose in week 12 (day 78) to post treatment follow-up (day 148)|Area under the semaglutide plasma concentration-time curve from 0-168 hours after administration of the 12th dose of semaglutide, h∙nmol/L, From administration of dose in week 12 (day 78) to day 85|The maximum concentration of semaglutide after administration of the 12th dose of semaglutide, nmol/L, From administration of dose in week 12 (day 78) to post treatment follow-up (day 148)
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| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
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| Gender: |
ALL
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| Age: |
ADULT
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| Phases: |
PHASE1
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| Enrollment: |
152
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2020-02-17
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| Completion Date: |
2022-03-16
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| Results First Posted: |
|
| Last Update Posted: |
2023-11-13
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| Locations: |
Novo Nordisk Investigational Site, Groningen, 9728 NZ, Netherlands
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| URL: |
https://clinicaltrials.gov/show/NCT04259801
|
