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NNC9204-1177 A /mL

Phase 1

Metabolism and Nutrition Disorder | Small molecule | Metabolic |Novo Nordisk A/S|Last Updated: Dec 23, 2021

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 Enrollment99
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03308721Research Study Investigating Study Medicine (NNC9204-1177) for Weight Management in People With Overweight or ObesityPHASE1 COMPLETED 99Oct 16, 2017Jan 3, 2020Dec 23, 20211 United States
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Study Endpoints
Primary Endpoints
Number of treatment emergent adverse events (TEAEs)
Day 1-110

Count of events

Secondary Endpoints
The area under the NNC9204-1177 serum concentration-time curve at steady state
0-168 hours
The maximum serum concentration of NNC9204-1177 at steady state
Day 78-110
The time to maximum serum concentration of NNC9204-1177
Day 78-110
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
NNC9204-1177EXPERIMENTALDose trial with a sequential trial design
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
NNC9204-1177 A 1.0 mg/mLDRUGParticipants will get 1 or more injections into the skin of the stomach area once each week for 12 weeks. Dose gradually increased to 6000 μg.
PLACEBODRUGParticipants will get 1 or more injections into the skin of the stomach area once each week for 12 weeks.
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Male or female, aged 18-55 years (both inclusive) at the time of signing informed consent * Body mass index (BMI) between 27.0 and 39.9 kg/m2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator Exclusion Criteria: *...

Countries:United States
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