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NNC0165-1562

Phase 1

Metabolism and Nutrition Disorders | Small molecule | Metabolic |Novo Nordisk A/S|Last Updated: Jul 2, 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-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment37
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03574584A Research Study of NNC0165-1562 and Semaglutide in People Who Are Overweight or ObesePHASE1 COMPLETED 37 — — Jun 18, 2018Jul 27, 2019Jul 2, 20212 United States
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Study Endpoints
Primary Endpoints
Number of treatment emergent adverse events (TEAEs)
Week 0-25

Count of adverse events.

Secondary Endpoints
AUC0-168h,1562,SS; the area under the NNC0165-1562 plasma concentration-time curve from time 0 to 168 hours at steady state
Week 19 (day 134) to week 20 (day 141)
AUC0-168h,sema,SS; the area under the semaglutide plasma concentration time curve from 0 to 168 hours at steady state
Week 19 (day 134) to week 20 (day 141)
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
NNC0165-1562 + SemaglutideEXPERIMENTALParticipants will receive NNC0165-1562 and semaglutide once weekly for 20 weeks.
Placebo (NNC0165-1562) + SemaglutideEXPERIMENTALParticipants will receive placebo (NNC0165-1562) and semaglutide once weekly for 20 weeks.
Interventions
NameTypeDescription
NNC0165-1562DRUGParticipants will receive NNC0165-1562 subcutaneous (s.c., under the skin) injection(s) once-weekly for 20 weeks. The dose will be escalated over 16 weeks to a final dose level that will be maintained for 4 weeks.
SemaglutideDRUGParticipants will receive semaglutide s.c. injection(s) once-weekly for 20 weeks. The dose will be escalated over 16 weeks to a final dose level that will be maintained for 4 weeks.
Placebo (NNC0165-1562)DRUGParticipants will receive placebo (NNC0165-1562) s.c. injection(s) once-weekly for 20 weeks.
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Eligibility Criteria
Age Range19 Years — 55 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Male or female, aged 19-55 years (both inclusive) at the time of signing informed consent. * Body mass index (BMI) between 27.0 and 39.9 kg/sqm (both inclusive) at screening. Obesity should be due to excess adipose tissue, as judged by the investigator. Exclusion Criteria: *...

Countries:United States
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