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NNC0385-0434

Phase 1

Healthy Volunteers | Small molecule | Metabolic |Novo Nordisk A/S|Last Updated: Jan 17, 2024

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 Trials2
Total Enrollment75
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05003440A Research Study Looking at How the Medicine NNC0385-0434 Works in the Body of Healthy Japanese MenPHASE1 COMPLETED 36 — — Aug 19, 2021Jan 19, 2022Jan 17, 20241 Japan
NCT04058834A Research Study Investigating How NNC0385-0434 is Tolerated in People With or Without High Cholesterol LevelsPHASE1 COMPLETED 39 — — Aug 20, 2019Apr 23, 2020Dec 30, 20211 United Kingdom
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Study Endpoints
Primary Endpoints
Number of treatment emergent adverse events (TEAEs)
From pre-dose (day 1) until completion of the post-treatment period at follow-up (day 65)

Count of events

Secondary Endpoints
AUC0-24h,0434,Day10,; the area under the NNC0385-0434 plasma concentration-time curve from time 0 to 24 h after last dose of oral NNC0385-0434
From last dose (day 10) 0 to 24 hours post treatment (day 11)
Cmax,0434,Day10,; the maximum plasma concentration of NNC0385-0434 after last dose of oral NNC0385-0434
From last dose (day 10) 0 hours to post treatment follow-up (day 65)
tmax,0434,Day10; the time to maximum observed plasma concentration of NNC0385-0434 after last dose of oral NNC0385-0434
From last dose (day 10) 0 hours to post treatment follow-up (day 65)
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
NNC0385-0434 15 mgEXPERIMENTAL15 mg oral NNC0385-0434 will be administered once-daily over 10 consecutive days
Placebo (NNC0385-0434 15 mg)PLACEBO_COMPARATOROral placebo will be administered once-daily over 10 consecutive days
NNC0385-0434 40 mgEXPERIMENTAL40 mg oral NNC0385-0434 will be administered once-daily over 10 consecutive days
Placebo (NNC0385-0434 40 mg)PLACEBO_COMPARATOROral placebo will be administered once-daily over 10 consecutive days
NNC0385-0434 100 mgEXPERIMENTAL100 mg oral NNC0385-0434 will be administered once-daily over 10 consecutive days
Placebo (NNC0385-0434 100 mg)PLACEBO_COMPARATOROral placebo will be administered once-daily over 10 consecutive days
NNC0385-0434EXPERIMENTALHealthy volunteers will be randomised to one of three cohorts. In each cohort of 8 participants, 6 will receive active drug and 2 will receive placebo. Following safety observation, patients with hypercholesterolaemia will enter a fourth cohort. There will be 15 participants in this cohort.
Placebo (NNC0385-0434)PLACEBO_COMPARATORHealthy volunteers will be randomised to one of three cohorts. In each cohort of 8 participants, 6 will receive active drug and 2 will receive placebo.
Interventions
NameTypeDescription
NNC0385-0434DRUGParticipants will get 1 tablet (oral use) of NNC0385-0434 per day for 10 days in either 15, 40 or 100 mg
PlaceboDRUGParticipants will get 1 tablet (oral use) of placebo per day for 10 days
Placebo (NNC0385-0434)DRUGHealthy volunteers will receive one injection s.c.
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Eligibility Criteria
Age Range20 Years — 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Body weight greater than or equal to 54.0 kg. * Body mass index (BMI) between 20.0 and 34.9 kg/m\^2 (both inclusive). Exclusion Criteria: * Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by ...

Countries:JapanUnited Kingdom
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