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NNC0705-0001

Phase 1

Chronic Kidney Disease | Small molecule | Nephrology |Novo Nordisk A/S|Trials Updated: Mar 11, 2026

NNC0705-0001 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jun 2025

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

NNC0705-0001 clinical trials

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?

NNC0705-0001 is an investigational small molecule medicine being developed by Novo Nordisk A/S for chronic kidney disease. It has been studied in a Phase 1 clinical trial in healthy volunteers, and it is not yet approved for any use. It belongs to the nephrology therapeutic area.

What is NNC0705-0001 used for?

NNC0705-0001 is being developed for chronic kidney disease, a nephrology condition. The only clinical study conducted so far enrolled healthy volunteers rather than patients with chronic kidney disease, so the drug remains investigational and has no approved indication.

Who makes NNC0705-0001?

NNC0705-0001 is developed by Novo Nordisk A/S, the Danish pharmaceutical company whose shares trade under the ticker NVO. Novo Nordisk is the sponsor of the Phase 1 study of the compound.

What phase is NNC0705-0001 in?

NNC0705-0001 is in Phase 1 development. One Phase 1 trial has been completed, and no later-stage trials have been recorded. The compound is investigational and has not been approved by the FDA or any other regulator for chronic kidney disease or any other indication.

What clinical trials is NNC0705-0001 in?

NNC0705-0001 has been evaluated in one completed Phase 1 trial, NCT07029568, titled a study to see how safe a new medicine (NNC0705-0001) is in healthy people. That trial enrolled 116 participants in the Netherlands, was randomized, double blind, and placebo controlled, and included healthy volunteers and people with chronic kidney disease.