Recent Updates
Recently added Catalysts

NNC0560-0004

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment51
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
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.PHASE1 COMPLETED 51Nov 13, 2023Jul 4, 2024Aug 20, 20251 United Kingdom
Unlock Drug Trial Details
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)
Unlock Study Endpoints
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)
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 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
Unlock Eligibility Criteria