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NNC9204-1177

Phase 1

Metabolism and Nutrition Disorder | Small molecule | Metabolic |Novo Nordisk A/S|Last Updated: Sep 5, 2018

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 Enrollment49
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02941042A First Human Dose Trial Investigating Safety, Tolerability and Pharmacokinetics for Single Doses of NNC9204-1177 in Subjects Being Overweight or With Obesity.PHASE1 COMPLETED 49 — — Oct 10, 2016Sep 30, 2017Sep 5, 20181 United States
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Study Endpoints
Primary Endpoints
Number of treatment emergent adverse events (TEAEs)
From time of dosing (day 1) until completion of the follow-up visit (day 39)
Secondary Endpoints
Area under the NNC9204-1177 serum concentration-time curve
From 0 to 168 hours after a single s.c. dose
Maximum serum concentration of NNC9204-1177
From time of dosing (day 1) until completion of the follow-up visit (day 39)
Time to maximum serum concentration of NNC9204-1177
From time of dosing (day 1) until completion of the follow-up visit (day 39)
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
NNC9204-1177EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
NNC9204-1177DRUGA single dose administered subcutaneously ( s.c. under the skin)
PlaceboDRUGA single dose administered subcutaneously ( s.c. under the skin)
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Eligibility Criteria
Age Range18 Years — 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male, aged 18-55 years (both inclusive) at the time of signing informed consent * Body mass index (BMI) between 25.0 and 34.9 kg/m\^2 (both inclusive) at screening Exclusion Criteria: * Any disorder which in the investigator's opinion might jeopardise subject's safety, evalu...

Countries:United States
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