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NNC0113-5840

Phase 1

Obesity | Small molecule | Metabolic |Novo Nordisk A/S|Last Updated: Jun 4, 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 Enrollment48
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07566390A Research Study Investigating How a New Medicine NNC0113-5840 Works in People With Overweight or ObesityPHASE1 RECRUITING 48May 1, 2026Nov 26, 2026Jun 4, 20261 United States
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Study Endpoints
Primary Endpoints
Number of treatment emergent adverse events (TEAEs)
From time of dosing (day 1) up to day 43

Measured as number of events.

Secondary Endpoints
AUC: Area under the NNC0113-5840 plasma concentration time-curve
From pre-dose (day 1) up to day 43
Cmax: Maximum observed NNC0113-5840 plasma concentration
From pre-dose (day 1) up to day 43
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cohort 1 NNC0113-5840EXPERIMENTALParticipants will be randomized to receive NNC0113-5840 single dose level 1 subcutaneously.
Cohort 2 NNC0113-5840EXPERIMENTALParticipants will be randomized to receive NNC0113-5840 single dose level 2 subcutaneously.
Cohort 3 NNC0113-5840EXPERIMENTALParticipants will be randomized to receive NNC0113-5840 single dose level 3 subcutaneously.
Cohort 4 NNC0113-5840EXPERIMENTALParticipants will be randomized to receive NNC0113-5840 single dose level 4 subcutaneously.
Cohort 5 NNC0113-5840EXPERIMENTALParticipants will be randomized to receive NNC0113-5840 single dose level 5 subcutaneously.
Cohort 6 NNC0113-5840EXPERIMENTALParticipants will be randomized to receive NNC0113-5840 single dose level 6 subcutaneously.
Placebo matching NNC0113-5840PLACEBO_COMPARATORParticipants will receive placebo matched to NNC0113-5840 subcutaneously.
Interventions
NameTypeDescription
NNC0113-5840DRUGNNC0113-5840 will be administered subcutaneously using needle and syringe in a lifted fold of the abdominal skin.
PlaceboDRUGPlacebo matched to NNC0113-5840 will be administered subcutaneously using needle and syringe in a lifted fold of the abdominal skin.
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Male or female 2. Age 18-55 years (both inclusive) at the time of signing the informed consent. 3. Body mass index (BMI) between 25.0 and 34.9 kilogram per meter square (kg/m2) (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the ...

Countries:United States
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Recent Changes (Last 90 Days)
LOWJun 4, 2026NCT07566390Status: NOT_YET_RECRUITING → RECRUITING
LOWJun 4, 2026NCT07566390Status: NOT_YET_RECRUITING → RECRUITING
LOWJun 4, 2026NCT07566390Status: NOT_YET_RECRUITING → RECRUITING
LOWJun 4, 2026NCT07566390Status: NOT_YET_RECRUITING → RECRUITING
LOWMay 24, 2026NCT07566390studyFirstPostDate: changed
LOWMay 21, 2026NCT07566390NEW_TRIAL: changed
LOWMay 21, 2026NCT07566390NEW_TRIAL: changed