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NNC9204-1706 A

Phase 1

Metabolism and Nutrition Disorder | Small molecule | Metabolic |Novo Nordisk A/S|Last Updated: Oct 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 Enrollment34
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03095807Investigation of Single Ascending Doses of NNC9204-1706 in Male Subjects Being Overweight or With ObesityPHASE1 COMPLETED 34 — — Mar 20, 2017Aug 31, 2017Oct 5, 20181 United States
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Study Endpoints
Primary Endpoints
Number of treatment-emergent adverse events (TEAEs)
From the time of dosing (Day 1) and until completion of the post-treatment follow-up visit (Days 10-13)

Count and % of events

Secondary Endpoints
Area under the NNC9204-1706 plasma concentration-time curve
Day 1- Day 7
Area under the NNC9204-1706 plasma concentration-time curve (0-24h)
Day 1- Day 7
Area under the NNC9204-1706 plasma concentration-time curve (0- to last quantifiable sample)
Day 1- Day 7
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
NNC9204-1706 AEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
NNC9204-1706 ADRUGAdministered subcutaneously (s.c., under the skin) Up to 7 dose cohorts will be investigated.
PlaceboDRUGAdministered subcutaneously (s.c., under the skin)
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Eligibility Criteria
Age Range18 Years — 55 Years
SexMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Male subjects 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. Overweight should be due to excess of adipose tissue, as judged by the investigator Exclusion Criteria:...

Countries:United States
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