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Semaglutide B, /mL

Phase 1

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |Novo Nordisk A/S|Last Updated: Oct 15, 2024

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 Enrollment20
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05689099A Research Trial Looking at the Comparability of 2 Different Concentrations of Semaglutide for the 0.5 Milligram (mg) DosePHASE1 COMPLETED 20Jan 17, 2023May 30, 2023Oct 15, 20241 United States
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Study Endpoints
Primary Endpoints
AUC0-last,sema 0.5mg: Area under the semaglutide concentration time curve from time 0 until last quantifiable measurement after single dose of subcutaneous semaglutide 0.5 mg
0-840 hours after a single dose of s.c. semaglutide 0.5 mg

Measured in hours\*nanomoles per liter (h\*nmol/L).

Cmax,sema,0.5mg: maximum observed semaglutide concentration-time after single dose of subcutaneous semaglutide 0.5 mg administration
0-840 hours after a single dose of s.c. semaglutide 0.5 mg

Measured in nanomoles per liter (nmol/L).

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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Sequence AEXPERIMENTALParticipants will be administered a single subcutaneous (s.c.) dose of 0.5 mg semaglutide B (1.34 mg/mL) in Period 1 followed by a single s.c. dose of 0.5 mg semaglutide B (0.68 mg/mL) in Period 2.
Sequence BEXPERIMENTALParticipants will be administered a single s.c. dose of 0.5 mg semaglutide B (0.68 mg/mL) in Period 1 followed by a single s.c. dose of 0.5 mg semaglutide B (1.34 mg/mL) in Period 2.
Interventions
NameTypeDescription
Semaglutide B, 1.34 mg/mLDRUGParticipants will receive single dose of 0.5 mg Semaglutide B, 1.34 mg/mL subcutaneously.
Semaglutide B, 0.68 mg/mLDRUGParticipants will receive single dose of 0.5 mg Semaglutide B, 0.68 mg/mL subcutaneously.
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male or female * Aged 18-55 years (both inclusive) at the time of signing informed consent * Body mass index (BMI) between 20.0 and 29.9 kilograms per meter square (kg/m\^2) (both inclusive) Exclusion Criteria: * Female who is pregnant, breast-feeding or intends to become pr...

Countries:United States
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