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NNC0638-0355

Phase 1

Obesity | Small molecule | Metabolic |Novo Nordisk A/S|Last Updated: Mar 17, 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-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment63
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06577766A Research Study on How NNC0638-0355, a New Medicine, Works in People Living With Overweight or ObesityPHASE1 ACTIVE NOT_RECRUITING 63Sep 3, 2024Sep 24, 2026Mar 17, 20261 United States
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Study Endpoints
Primary Endpoints
Part A: Number of treatment emergent adverse events (TEAE)
From NNC0638-0355 administration (day 1) to completion of the end of study visit (6 weeks)

Measured as Number of events

Part B,C,D and E : Number of treatment emergent adverse events (TEAE)
From first NNC0638-0355 administration (day 1) to completion of the end of study visit (20 weeks)

Measured as Number of events

Secondary Endpoints
Part A: AUC; area under the NNC0638-0355 plasma concentration-time curve
From NNC0638-0355 administration (day 1) to completionof the end of study visit (6 weeks)
Part A: Cmax; maximum observed NNC0638-0355 plasma concentration
From NNC0638-0355 administration (day 1) to completionof the end of study visit (6 weeks)
Part B,C,D and E: AUC; area under the NNC0638-0355 plasma concentration-time curve
From first NNC0638-0355 administration (day 1) to completionof the end of study visit (20 weeks)
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
NNC0638-0355EXPERIMENTALParticipants will be randomized to receive NNC0638-0355. The study will be conducted in 5 parts. Part A: Single ascending dose (SAD) Part B, C, D and E: Multiple ascending dose (MAD).
PlaceboPLACEBO_COMPARATORParticipants will be randomized to receive Placebo. The study will be conducted in 5 parts. Part A: Single ascending dose (SAD). Part B, C,D and E: Multiple ascending dose (MAD).
Interventions
NameTypeDescription
NNC0638-0355DRUGNNC0638-0355 will be administered as a subcutaneous (s.c. under the skin) injection.
Placebo (NNC0638-0355)DRUGPlacebo matching NNC0638-0355 will be administered as subcutaneous (s.c. under the skin) injection.
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersNo
Study Sites1

Key inclusion criteria * Male or female. * Age 18-55 years (both inclusive) at the time of signing the informed consent. * BMI between 25.0 and 34.9 kg/m\^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator. * Considered to be generally ...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06577766primaryCompletionDate: changed
LOWMay 24, 2026NCT06577766studyFirstPostDate: changed