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NNC0247-0829

Phase 1

Overweight | Small molecule | Metabolic |Novo Nordisk A/S|Last Updated: Jan 23, 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_CONTROLLED
Total Trials1
Total Enrollment103
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04010786A Research Study Investigating NNC0247-0829 for Weight Management in People With Overweight or ObesityPHASE1 COMPLETED 103 — — Jul 11, 2019Jun 21, 2022Jan 23, 20241 United States
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Study Endpoints
Primary Endpoints
For single dose (SD) cohorts: Number of treatment emergent adverse events (TEAEs)
From time of first dosing (Day 1) until Day 71

Number of events

For multiple dose (MD) cohorts: Number of treatment emergent adverse events (TEAEs)
From time of first dosing (Day 1) until Day 85

Number of events

Secondary Endpoints
For SD cohorts: Number of injection site reactions
From time of first dosing (Day 1) until Day 71
For SD cohorts: Occurrence of anti-NNC0247-0829 antibodies
From time of first dosing (Day 1) until Day 71
For MD cohorts: Number of injection site reactions
From time of first dosing (Day 1) until Day 85
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Active treatment NNC0247-0829EXPERIMENTALUp to 6 single dose cohorts are planned with 10 subjects in each; 8 will receive active treatment. Up to 2 multiple dose cohorts are planned with 12 subjects in each; 8 will receive active treatment
PlaceboPLACEBO_COMPARATORIn each of the 6 single dose cohorts, 2 subjects will receive placebo. In the 2 multiple dose cohorts, 4 subjects will receive placebo
Interventions
NameTypeDescription
NNC0247-0829DRUGParticipants will receive either single or multiple doses given subcutaneously (s.c., under the skin) in a lifted fold of the stomach skin. Dose level and number of doses will depend on the cohort.
Placebo (NNC0247-0829)DRUGParticipants will receive either single or multiple doses of placebo given s.c. in a lifted fold of the stomach skin.
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Female not of childbearing potential (CBP) or male, aged 18-60 years (both inclusive) at the time of signing informed consent. * Body mass index (BMI) between 27.0 and 34.9 kg/m\^2 (both inclusive) in the SD cohorts and between 27.0 and 39.9 kg/m\^2 (both inclusive) in the MD ...

Countries:United States
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