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NNC0472-0147

Phase 1

Healthy Volunteers | Small molecule | Metabolic |Novo Nordisk A/S|Last Updated: Sep 28, 2022

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 Enrollment36
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04262661A Study to Look at How Safe NNC0472-0147 is in Healthy People and in People With Type 2 DiabetesPHASE1 COMPLETED 36 — — Mar 2, 2020Sep 25, 2020Sep 28, 20222 Germany
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Study Endpoints
Primary Endpoints
Part 1: Number of treatment emergent adverse events
From IMP administration at day 1 (visit 2) until completion of post-treatment end-of-trial visit (day 15, visit 6)

Number of events

Part 2: Number of treatment emergent adverse events
From IMP administration at day 1 (visit 2) until completion of post-treatment end-of-trial visit (day 30, visit 14)

Number of events

Secondary Endpoints
Number of hypoglycaemic episodes of alert value (level 1) below 3.9 mmol/L (70 mg/dL) and equal to or above 3.0 mmol/L (54 mg/dL)
From IMP administration at day 1 (visit 2) until completion of post-treatment end-of-trial visit (day 15, visit 6)
Number of clinically significant hypoglycaemic episodes (level 2) below 3.0 mmol/L (54 mg/dL)
From IMP administration at day 1 (visit 2) until completion of post-treatment end-of-trial visit (day 15, visit 6)
Number of severe hypoglycaemic episodes (level 3)
From IMP administration at day 1 (visit 2) until completion of post-treatment end-of-trial visit (day 15, visit 6)
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
NNC0472-0147 Part 1EXPERIMENTALPart 1: Each cohort will consist of 8 healthy subjects - 6 subjects will receive a single subcutaneous (s.c., under the skin) dose of NNC0472-0147.
Placebo Part 1PLACEBO_COMPARATORPart 1: Each cohort will consist of 8 healthy subjects - 2 subjects will receive a single s.c. dose of placebo.
NNC0472-0147 Part 2EXPERIMENTALPart 2: Each cohort will consist of 12 subjects with T2DM. 9 subjects will receive once daily s.c. doses of NNC0472-0147 for 14 days
Insulin glargine Part 2ACTIVE_COMPARATORPart 2: Each cohort will consist of 12 subjects with T2DM - 3 subjects will receive once daily s.c. doses of insulin glargine for 14 days.
Interventions
NameTypeDescription
NNC0472-0147DRUGPart 1: A single dose of NNC0472-0147, dose increased in each cohort. Part 2: Daily doses of NNC0472-0147, dose increased in each cohort.
insulin glargineDRUGPart 2: A fixed dose level of 0.5 U/kg insulin glargine will be used in all cohorts.
Placebo (NNC0472-0147)DRUGPart 1: A single dose of placebo, dose increased in each cohort.
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Eligibility Criteria
Age Range18 Years — 64 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: Part 1: * Male * Aged 18-55 years (both inclusive) at the time of signing nformed consent. Part 2: * Male, or female of non-child bearing potential. Non-child bearing potential is defined by being surgically sterilised (documented hysterectomy, bilateral salpingectomy or bila...

Countries:Germany
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