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NNC6022-0001

Phase 1

Healthy Volunteers | Small molecule | Metabolic |Novo Nordisk A/S|Last Updated: Apr 16, 2025

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-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment56
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06336005A Study to See How Safe a New Medicine (NNC6022-0001) is in Healthy PeoplePHASE1 COMPLETED 56 — — Mar 28, 2024Feb 17, 2025Apr 16, 20251 Netherlands
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Study Endpoints
Primary Endpoints
Number of treatment emergent adverse events (TEAE)
From time of dosing (Day 1) to end of study (Day 14)

Number of events

Secondary Endpoints
AUC0-t, SD; the area under the NNC6022 0001 plasma concentration-time curve from time 0 to last measurable plasma concentration after a single dose
From pre-dose (Day 1) to end of exposure (Day 7)
AUC0-∞, SD; the area under the NNC6022 0001 plasma concentration-time curve from time 0 to infinity after a single dose
From pre-dose (Day 1) to end of exposure (Day 7)
Cmax, SD; the maximum plasma concentration of NNC6022 0001 after a single dose
From pre-dose (Day 1) to end of exposure (Day 7)
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
NNC6022-0001EXPERIMENTALParticipants will be randomised to NNC6022-0001.
Placebo (NNC6022-0001)PLACEBO_COMPARATORParticipants will be randomised to placebo.
Interventions
NameTypeDescription
NNC6022-0001DRUGParticipants will recieve single ascending dose (SAD) of NNC6022-0001. Dose is given in escalating manner for up to seven cohorts.
Placebo (NNC6022-0001)DRUGParticipants will recieve single ascending dose (SAD) of placebo. Placebo is given in escalating manner for up to seven cohorts
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Men or women of non-childbearing potential. 2. Age 18-55 years (both inclusive) at the time of signing the informed consent. 3. Body mass index (BMI) between 18.5 to 29.9 kg/m\^2 (both inclusive) at screening. 4. Body Weight: Greater than or equal to 50 kg at screening. 5. Co...

Countries:Netherlands
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