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NNC0560-0004

Phase 1

Healthy Volunteers - Liver Diseases | Small molecule | Gastrointestinal |Novo Nordisk A/S|Last Updated: Aug 20, 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment51

FDA Designations

No designations recorded

Clinical trial landscape

NNC0560-0004 · 1 trial · 1 indication

Phase 1 1
NCT06133270A First Human Dose Study Investigating Safety and Concentration of Study Medicine in the Blood Following Once Daily Oral Dosing of NNC0560-0004 in Healthy Adults.Healthy Volunteers - Liver Diseases
COMPLETED51 Analytics
PHASE1COMPLETED
A First Human Dose Study Investigating Safety and Concentration of Study Medicine in the Blood Following Once Daily Oral Dosing of NNC0560-0004 in Healthy Adults.
Healthy Volunteers - Liver DiseasesUnlock trial analytics

Study Endpoints

Primary Endpoints

Part A: Number of treatment-emergent adverse events (TEAE)
From pre-dose (day 1) to end of study, Part A (up to day 13)

Number of events

Part B: Number of treatment-emergent adverse events (TEAE)
From pre-dose (day 1) to end of study, Part B (up to day 26)

Number of events

Part C: Number of treatment-emergent adverse events (TEAE)
From pre-dose (day 1) to end of study, Part C (up to day 84)

Number of events

Secondary Endpoints

Part A: AUC0-∞, SD: the area under the NNC0560-0004 plasma concentration-time curve from time 0 to infinity after a single dose
From pre-dose (day 1) to end of study, Part A (up to day 13)
Part A: Cmax, SD: the maximum plasma concentration of NNC0560-0004 after a single dose
From pre-dose (day 1) to end of study, Part A (up to day 13)
Part A: tmax, SD: the time to maximum concentration of NNC0560-0004 after a single dose
From pre-dose (day 1) to end of study, Part A (up to day 13)
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
NNC0560-0004EXPERIMENTALThe study will be conducted in 3 parts. Participants will be randomized to receive NNC0560-0004 in Part A: Single ascending dose (SAD) Part B: Multiple ascending dose (MAD) No randomisation - only active treatment in Part C: Single dose
Placebo (NNC0560-0004)PLACEBO_COMPARATORParticipant will be randomized to receive placebo in: Part A: Single ascending dose (SAD) Part B: Multiple ascending dose (MAD)

Interventions

NameTypeDescription
NNC0560-0004DRUGNNC0560-0004, Oral administration (taken through the mouth)
Placebo (NNC0560-0004)DRUGPlacebo matching NNC0560-0004, Oral administration (taken through the mouth)
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Key inclusion criteria: 1. Female, of non-childbearing potential, or male, both genders aged 18-55 years (both inclusive) at the time of signing informed consent. 2. Body Mass Index (BMI) between 18.5 and 29.9 kg/m\^2 (both inclusive) at screening. 3. Considered to be generally healthy based on the...

Countries:United Kingdom
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Frequently asked questions about NNC0560-0004

What is NNC0560-0004 used for?

NNC0560-0004 is an investigational small molecule being studied for use in healthy volunteers and for liver diseases. It is in Phase 1 clinical development, with a completed first-in-human trial that assessed safety and blood concentrations after once-daily oral dosing in healthy adults.

Who makes NNC0560-0004?

NNC0560-0004 is being developed by Novo Nordisk A/S, a biopharmaceutical company listed on the stock exchange under the ticker symbol NVO. The company is conducting clinical trials to evaluate this investigational small molecule.

What phase is NNC0560-0004 in?

NNC0560-0004 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. A Phase 1 trial has been completed, and the drug remains under clinical investigation for its potential use in liver diseases.

What clinical trials is NNC0560-0004 in?

NNC0560-0004 has one completed clinical trial, identified as NCT06133270. This was a first-in-human, Phase 1, randomized, double-blind, placebo-controlled study in the United Kingdom, enrolling 51 healthy adults to evaluate safety and blood concentrations following once-daily oral dosing.

Is NNC0560-0004 the same as any other drug?

NNC0560-0004 is the primary name for this investigational drug. No alternative names have been reported for this compound in the available clinical trial information. It is being studied under this identifier in its Phase 1 development program.

How is NNC0560-0004 administered?

NNC0560-0004 is administered orally, once daily, as a small molecule. In the completed Phase 1 trial, healthy adult participants received the study medicine by mouth to assess its safety and how much of the drug reached the blood over time.