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NNC0705-0001

Phase 1

Healthy Volunteers | Small molecule | Nephrology |Novo Nordisk A/S|Last Updated: Mar 11, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment116
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07029568A Study to See How Safe a New Medicine (NNC0705-0001) is in Healthy PeoplePHASE1 COMPLETED 116Jun 13, 2025Dec 10, 2025Mar 11, 20261 Netherlands
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Study Endpoints
Primary Endpoints
PART A: Number of treatment emergent adverse events (TEAE)
From time of dosing (day 1) to end of study (day 7)

Measured in number of events.

PART B: Number of TEAEs
From time of dosing (day 1) to end of study (day 13)

Measured in number of events.

AUC, SD; the area under the NNC0705-0001 plasma concentration-time curve after a single dose
From pre-dose (day 1 or day 8) to day 2 or day 9

Measured in Hour x Micromole (hr×μM).

Secondary Endpoints
PART A: AUC0-t, SD; the area under the NN0705-0001 plasma concentration-time curve from time 0 to last measurable plasma concentration after a single dose
From pre-dose (day 1) to day 5
PART A: AUC0-∞, SD; the area under the NNC0705-0001 plasma concentration-time curve from time 0 to infinity after a single dose
From pre-dose (day 1) to day 5
PART A: Cmax, SD; the maximum plasma concentration of NNC0705-0001 after a single dose
From pre-dose (day 1) to day 5
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part A: NNC0705-0001EXPERIMENTALParticipants will receive 6 different single ascending doses of NNC0705-0001 via oral administration.
Part A: PlaceboPLACEBO_COMPARATORParticipants will receive single ascending dose of placebo matching NNC0705-0001 via oral administration.
Part B: NNC0705-0001EXPERIMENTALParticipants will receive 4 different multiple ascending doses of NNC0705-0001 via oral administration.
Part B: PlaceboPLACEBO_COMPARATORParticipants will receive multiple ascending doses of placebo matching NNC0705-0001 via oral administration.
Part C: NNC0705-0001EXPERIMENTALParticipants will receive 2 separate single doses of NNC0705-0001 at a previously safety-cleared dose level in PART A, either in a fed or fasted state.
Interventions
NameTypeDescription
NNC0705-0001DRUGNNC0705-0001 will be administered orally.
PlaceboDRUGPlacebo matching NNC0705-0001 will be administered orally.
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Eligibility Criteria
Age Range18 Years — 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 meter square (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)
MEDIUMMay 21, 2026NCT07029568TRIAL_REMOVED: changed
MEDIUMMay 21, 2026NCT07029568TRIAL_REMOVED: changed