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NNC0705-0001

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment116

FDA Designations

No designations recorded

Clinical trial landscape

NNC0705-0001 · 1 trial · 2 indications

Phase 1 1
NCT07029568A Study to See How Safe a New Medicine (NNC0705-0001) is in Healthy PeopleHealthy Volunteers
COMPLETED116 Analytics
PHASE1COMPLETED
A Study to See How Safe a New Medicine (NNC0705-0001) is in Healthy People
Healthy VolunteersUnlock trial analytics

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 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 meter square (kg/m\^2) (both inclusive) at screening. * Body weight: greater than or equal to ...

Countries:Netherlands
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Frequently asked questions about NNC0705-0001

What is NNC0705-0001 used for?

NNC0705-0001 is an investigational small molecule being developed by Novo Nordisk for use in healthy volunteers, with a study also including participants with chronic kidney disease. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.

Who makes NNC0705-0001?

NNC0705-0001 is being developed by Novo Nordisk A/S, a biopharmaceutical company traded on the NYSE under the ticker symbol NVO. The drug is an investigational small molecule in the nephrology therapeutic area.

What phase is NNC0705-0001 in?

NNC0705-0001 is in Phase 1 clinical development. One Phase 1 trial has been completed, and the drug remains investigational. It has not been approved by the FDA or any other regulatory agency.

What clinical trials is NNC0705-0001 in?

NNC0705-0001 has one completed Phase 1 trial, NCT07029568, titled "A Study to See How Safe a New Medicine (NNC0705-0001) is in Healthy People." The trial enrolled 116 participants in the Netherlands, was randomized, double-blind, and placebo-controlled.

Is NNC0705-0001 the same as any other drug?

No alternative names for NNC0705-0001 have been disclosed. The drug is identified solely by its code name NNC0705-0001 in clinical trial registries and company communications.