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NNC9204-1706

Phase 1

Metabolism and Nutrition Disorder | Small molecule | Metabolic |Novo Nordisk A/S|Last Updated: Oct 18, 2019

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 Enrollment60
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03661879Research Study of a New Medicine (NNC9204-1706) in People With Overweight or ObesityPHASE1 COMPLETED 60Sep 12, 2018Oct 9, 2019Oct 18, 20191 United States
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Study Endpoints
Primary Endpoints
Number of treatment emergent adverse events (TEAEs)
Days 1-84

Count of adverse events.

Secondary Endpoints
Change in time-profile (msec) in individual corrected QT interval (ΔQTcI)
Day 1, Day 84
AUC0-24h,SS (h*nmol/L); the area under the NNC9204-1706 plasma concentration-time curve from time 0 to 24 hours at steady state
Days 1-84
Cmax,SS (nmol/L); the maximum plasma concentration of NNC9204-1706 at steady state
Days 1-84
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
NNC9204-1706EXPERIMENTALParticipants will receive NNC9204-1706 for 10 weeks. There will be a 2-week follow-up period after the treatment period.
Placebo (NNC9204-1706)PLACEBO_COMPARATORParticipants will receive placebo (NNC9204-1706) for 10 weeks. There will be a 2-week follow-up period after the treatment period.
Interventions
NameTypeDescription
NNC9204-1706DRUGParticipants will receive NNC9204-1706 subcutaneous (s.c., under the skin) injection(s) once daily (OD) for 10 weeks. They will either receive the same dose throughout the trial, or the dose will be escalated over a period of 1-3 weeks and continued for at least 7 weeks at the same dose.
Placebo (NNC9204-1706)DRUGParticipants will receive matching placebo (NNC9204-1706) s.c., injection(s) OD for 10 weeks.
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
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 25.0 and 39.9 kg/m\^2 (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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