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Dasiglucagon

Phase 1

Diabetes Mellitus, Type 1 | Small molecule | Metabolic |Novo Nordisk A/S|Last Updated: Dec 5, 2025

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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment38
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06588504Research Study in Japan to Compare Dasiglucagon With Glucagon in Treating Very Low Levels of Blood Sugar in Asian Adults With Type 1 Diabetes and Testing of Dasiglucagon for the Same Condition in Japanese AdolescentsPHASE1 COMPLETED 38 — — Sep 10, 2024Jul 20, 2025Dec 5, 20251 Japan
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Study Endpoints
Primary Endpoints
Adults cohort: Time to plasma glucose (PG) recovery, where PG recovery is defined as the first increase in PG of greater than or equal to (>=) 20 milligrams per decilitre (mg/dL) (1.1 millimoles per litre [mmol/L]) from baseline
From 0 to 90 minutes after investigational medicinal product (IMP) injection

Measured in minutes.

Secondary Endpoints
Adolescent cohort: Time to PG recovery, where PG recovery is defined as the first increase in PG of >=20 mg/dL (1.1 mmol/L) from baseline
From 0 to 90 minutes after IMP injection
PG recovery within 30 minutes after IMP injection (yes/no)
From 0 to 30 minutes after IMP injection
PG recovery within 20 minutes after IMP injection (yes/no)
From 0 to 20 minutes after IMP injection
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Adult Cohort: Dasiglucagon then GlucagonEXPERIMENTALParticipants will receive a single subcutaneous (s.c.) injection of dasiglucagon in first dosing visit then a single intra-mascular (i.m.) injection of glucagon in next dosing visit.
Adult Cohort: Glucagon then DasiglucagonEXPERIMENTALParticipants will receive a single i.m. injection of glucagon in first dosing visit then a single s.c. injection of dasiglucagon in next dosing visit.
Adolescent Cohort: DasiglucagonEXPERIMENTALParticipants will receive a single s.c. injection of dasiglucagon.
Interventions
NameTypeDescription
DasiglucagonDRUGParticipants will receive s.c. injection of dasiglucagon.
GlucagonDRUGParticipants will receive i.m. injection of glucagon.
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Eligibility Criteria
Age Range12 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * For Adults: Asian male or female; For Adolescents: Japanese male or female. * Age at the time of signing the informed consent: For Adults: Age 18-75 years (both inclusive): For Adolescents: Age 12-15 years (both inclusive). * Diagnosed with T1D greater than (\>)1 year befor...

Countries:Japan
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