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NNC0705-0002

Phase 1

Healthy Volunteers | Small molecule | Cardiovascular |Novo Nordisk A/S|Last Updated: Sep 1, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment112

FDA Designations

No designations recorded

Clinical trial landscape

NNC0705-0002 · 1 trial · 2 indications

Phase 1 1
NCT07797855A Study to See How Safe a New Medicine (NNC0705-0002) is in Healthy PeopleHealthy Volunteers
NOT YET_RECRUITING112 Analytics
PHASE1NOT YET_RECRUITING
A Study to See How Safe a New Medicine (NNC0705-0002) is in Healthy People
Healthy Volunteers
NCT07797855112
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Study Endpoints

Primary Endpoints

Number of treatment emergent adverse events (TEAEs)
From time of dosing (day 1) to day 7

Measured as number of events.

Number of TEAEs
From time of dosing (day 1) to day 13

Measured as number of events.

AUC0-t, SD; the area under the NNC0705- 0002 plasma concentration-time curve from time 0 to last measurable plasma concentration after a single dose
From pre-dose (day 1 or day 10) to day 6 or day 15

Measured as hour micromolar (h\*μM).

Total recovery of administered radiolabelled NNC0705- 0002-related material (sum urine and faeces)
From time of dosing (day 1) to no later than day 21

Measured as percentage (%) of dose.

Secondary Endpoints

AUC0-∞, SD; the area under the NNC0705- 0002 plasma concentration-time curve from time 0 to infinity after a single dose
From pre-dose (day 1) to day 7
Cmax, SD; the maximum observed plasma concentration of NNC0705-0002 after a single dose
From pre-dose (day 1) to day 7
AUCtau, MD; the area under the NNC0705- 0002 plasma concentration-time curve from time 0 to tau after the last dose
From pre-dose (day 7) to tau after last dose (day 8)
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
NNC0705-0002EXPERIMENTALParticipants will receive NNC0705-0002 administered orally as a single ascending dose (SAD), multiple ascending dose (MAD), or under fed/fasted conditions.
PlaceboPLACEBO_COMPARATORParticipants will receive placebo matched to NNC0705-0002 administered orally as a SAD, MAD, or under fed/fasted conditions.

Interventions

NameTypeDescription
NNC0705-0002DRUGParticipants will receive oral capsule of NNC0705-0002.
PlaceboDRUGParticipants will receive oral capsule of placebo matched to NNC0705-0002.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Men or women of non-childbearing potential. * Age 18-55 years (both inclusive) at the time of signing the informed consent. * Body mass index (BMI) between 18.5 to 29.9 kilogram per square metre (kg/m\^2) (both inclusive) at screening. * Body weight: greater than or equal to (...

Countries:Netherlands
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Recent Changes (Last 90 Days)

LOWSep 1, 2026NCT07797855NEW_TRIAL: changed
LOWSep 1, 2026NCT07797855NEW_TRIAL: changed