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NNC0581-0001

Phase 1

Healthy Volunteers | Small molecule | Gastrointestinal |Novo Nordisk A/S|Last Updated: Apr 7, 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-BlindCONTROLLEDBiomarker
Total Trials2
Total Enrollment96
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06891365Multiple Dose Study for a New Medication to Potentially Treat Liver DiseasesPHASE1 RECRUITING 48 — — Mar 12, 2025Nov 15, 2027Apr 7, 20261 United Kingdom
NCT05599945First Human Dose Trial for a New Medication to Potentially Treat Liver DiseasesPHASE1 COMPLETED 48 — — Nov 23, 2022Aug 29, 2025Oct 9, 20252 United Kingdom
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Study Endpoints
Primary Endpoints
Number of treatment emergent adverse events (TEAEs)
From 1st dose (day 1) until completion of the end of study visit at week 52

Measured as count of events.

Secondary Endpoints
AUC0-32h: The area under the NNC0581-0001 plasma concentration-time curve from time zero to 32 hours after each of the three doses
From dosing (day 1 in each treatment period) to 32 hours post dose
Cmax: The maximum concentration of NNC0581-0001 in plasma after each dose of three doses
From dosing (day 1 in each treatment period) to 32 hours post dose
Tmax: The time from dose administration to maximum plasma concentration of NNC0581-0001 after each dose of three doses
From dosing (day 1 in each treatment period) to 32 hours post dose
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cohort 1: NNC0581-0001 (Dose 1)EXPERIMENTALParticipants will receive a subcutaneous (s.c) injection of either NNC0581-0001 Dose 1 or a matching placebo once monthly.
Cohort 2: NNC0581-0001 (Dose 2)EXPERIMENTALParticipants will receive a s.c injection of either NNC0581-0001 Dose 2 or a matching placebo once monthly.
Single Dose 1: NNC0581-0001 10 milligram (mg)EXPERIMENTALPart A: Healthy participants will receive a single dose of NNC0581-0001 10 mg or matching placebo injection subcutaneously.
Single Dose 2: NNC0581-0001 30 mgEXPERIMENTALPart A: Healthy participants will receive a single dose of NNC0581-0001 30 mg or matching placebo injection subcutaneously.
Single Dose 3: NNC0581-0001 90 mgEXPERIMENTALPart A: Healthy participants will receive a single dose of NNC0581-0001 90 mg or matching placebo injection subcutaneously.
Single Dose 4: NNC0581-0001 250 mgEXPERIMENTALPart A: Healthy participants will receive a single dose of NNC0581-0001 250 mg or matching placebo injection subcutaneously.
Single Dose 5: NNC0581-001 600 mgEXPERIMENTALPart B: Participants with hepatic steatosis will receive a single dose of NNC0581-0001 600 mg or matching placebo injection subcutaneously.
Single Dose 6: NNC0581-001 1000 mgEXPERIMENTALPart B: Participants with hepatic steatosis will receive a single dose of NNC0581-0001 1000 mg or matching placebo injection subcutaneously.
Interventions
NameTypeDescription
NNC0581-0001DRUGNNC0581-0001 will be administered subcutaneously.
Placebo (NNC0581-0001)DRUGPlacebo matched to NNC0581-0001 will be administered subcutaneously.
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Eligibility Criteria
Age Range18 Years — 64 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator. * Male or female (of non-childbearing potential) aged 18...

Countries:United Kingdom
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Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT06891365primaryCompletionDate: changed
LOWMay 24, 2026NCT06891365studyFirstPostDate: changed