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NNC9204-0530

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 Trials3
Total Enrollment398
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02870231Investigating Safety, Tolerability, PK and PD for Multiple Doses of NNC9204-0530 in Combination With Liraglutide in Male and Female Subjects Being Overweight or With ObesityPHASE1 COMPLETED 187Aug 18, 2016Sep 3, 2017Sep 5, 20182 United States
NCT02835235A Trial Investigating Safety, Tolerability, PK and PD for Multiple Doses of NNC9204-0530 in Male and Female Subjects Being Overweight or With ObesityPHASE1 COMPLETED 48Jul 26, 2016Jul 7, 2017Jan 8, 20182 United States
NCT02235961Investigate Safety, Tolerability and Pharmacokinetics for Single Doses of NNC9204-0530 Alone and in Combination With Liraglutide in Overweight to Obese But Otherwise Healthy Male SubjectsPHASE1 COMPLETED 163Sep 4, 2014Jul 6, 2016Jul 27, 20171 United States
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Study Endpoints
Primary Endpoints
Number of treatment emergent adverse events
Day 1-112
Number of treatment emergent adverse events recorded
From time of dosing of NNC9204-0530 (Day 1) until completion of the follow-up visit (Day 21-27)
Secondary Endpoints
Area under the NNC9204-0530 serum concentration-time curve
Day 84-112
Time to maximum serum concentration of NNC9204-0530
Day 84-112
Change in HbA1C
Day -1, Day 85
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
NNC9204-0530 / Placebo and Liraglutide 1.8EXPERIMENTAL -
NNC9204-0530 /Placebo and Liraglutide 3.0ACTIVE_COMPARATOR -
NNC9204-0530EXPERIMENTALDose-escalation within the cohort before reaching final dose
PlaceboPLACEBO_COMPARATOR -
Part 1EXPERIMENTAL -
Part 2EXPERIMENTAL -
Interventions
NameTypeDescription
NNC9204-0530DRUGOnce-daily subcutaneous (s.c., under the skin) administration.
liraglutideDRUGOnce-daily subcutaneous (s.c., under the skin) administration.
placeboDRUGOnce-daily subcutaneous (s.c., under the skin) administration
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Body mass index between 25.0 and 39.9 kg/m\^2 (both inclusive) at screening. * Male or female, age between 18 and 55 years (both inclusive) at the time of signing informed consent Exclusion Criteria: * Any clinically significant weight change (equal or above 5% self-reported...

Countries:United States
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