Recent Updates
Recently added Catalysts

NNC0148-0287sema

Phase 1

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |Novo Nordisk A/S|Last Updated: Nov 12, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment30
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03789578A Research Study to Look at How Insulin 287 and Semaglutide Work in the Body of People With Type 2 Diabetes When Taken Alone or TogetherPHASE1 COMPLETED 30Jan 17, 2019Oct 10, 2019Nov 12, 20241 Germany
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
AUCI287, 0-tz, area under the serum insulin 287 concentration-time curve from 0 hours to last quantifiable observation after a single dose
0-840 hours

Measured in pmol\*h/L for insulin 287 following administration of a fixed ratio of NNC0148-0287sema and insulin 287.

AUCSema,0-tz, area under the plasma semaglutide concentration-time curve from 0 hours to last quantifiable observation after a single dose
0-840 hours

Measured in pmol\*h/L for semaglutide following administration of a fixed ratio of NNC0148-0287sema and semaglutide.

Secondary Endpoints
AUCI287,0-∞ area under the serum insulin 287 concentration-time curve from 0 hours to infinity after a single dose
0-840 hours
Cmax, I287, maximum observed serum insulin 287 concentration after a single dose
0-840 hours
tmax, I287, time to maximum observed serum insulin 287 concentration after a single dose
0-840 hours
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Semaglutide plus insulin 287EXPERIMENTALParticipants will get a single dose of fixed-ratio combination of insulin 287 and semaglutide (NNC0148-0287sema (treatment C)).
Semaglutide aloneEXPERIMENTALParticipants will get a single dose of semaglutide (treatment B) alone.
Insulin 287 aloneEXPERIMENTALParticipants will get a single dose of insulin 287 (NNC0148-0287 (treatment A)) alone.
Interventions
NameTypeDescription
NNC0148-0287semaDRUGStudy staff will inject NNC0148-0287sema, 175unit (U)/0.5 mg in the morning after fasting under the skin of participants' thigh using a needle and a pen.
SemaglutideDRUGStudy staff will inject semaglutide, 0.5 mg alone in the morning after fasting under the skin of participants' thigh using a needle and a pen.
NNC0148-0287DRUGStudy staff will inject insulin 287 (NNC0148-0287), 175U alone in the morning after fasting under the skin of participants' thigh using a needle and a pen.
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 64 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Male or female, aged 18-64 years (both inclusive) at the time of signing informed consent * Diagnosed with type 2 diabetes mellitus more than or equal to 180 days prior to the day of screening * Body weight between 80.0 to 120.0 kg (both inclusive) * Glycosylated haemoglobin (...

Countries:Germany
Unlock Eligibility Criteria