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Semaglutide B

Phase 1

Healthy Volunteers Type 2 Diabetes | Small molecule | Metabolic |Novo Nordisk A/S|Last Updated: Oct 20, 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 Enrollment90
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06642584A Research Study Looking at New Protein-based Tablets in Healthy Men - Oral Formulation IVPHASE1 COMPLETED 90 — — Oct 15, 2024Aug 13, 2025Oct 20, 20251 Canada
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Study Endpoints
Primary Endpoints
Adjusted AUC(sema); adjusted area under the semaglutide plasma concentration-time curve
From 0 to 24 hours after dosing on Days 122 and 132.

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

Adjusted Cmax,(sema); adjusted maximum observed semaglutide plasma concentration
From 0 to 24 hours after dosing on Days 122 and 132.

Measured in nanomoles per liter(nmol/L).

Adjusted tmax,sema; time to adjusted maximum observed semaglutide plasma concentration
From 0 to 24 hours after dosing on Days 122 and 132.

Measured in hours.

t½,sema; the terminal half-life of semaglutide
From 0 to 840 hours after dosing on Day 132.

Measured in hours.

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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Sequence 1: Semaglutide J then Semaglutide LEXPERIMENTALParticipants will receive subcutaneously semagutide B in treatment period 1 followed by oral semaglutide J then semaglutide L in treatment period 2.
Sequence 2: Semaglutide L then Semaglutide JEXPERIMENTALParticipants will receive subcutaneously semagutide B in treatment period 1 followed by oral semaglutide L then semaglutide J in treatment period 2.
Sequence 3: Semaglutide J then Semaglutide MEXPERIMENTALParticipants will receive subcutaneously semagutide B in treatment period 1 followed by oral semaglutide J then semaglutide M in treatment period 2.
Sequence 4: Semaglutide M then Semaglutide JEXPERIMENTALParticipants will receive subcutaneously semagutide B in treatment period 1 followed by oral semaglutide M then semaglutide J in treatment period 2.
Sequence 5: Semaglutide J then Semaglutide NEXPERIMENTALParticipants will receive subcutaneously semagutide B in treatment period 1 followed by oral semaglutide J then semaglutide N in treatment period 2.
Sequence 6: Semaglutide N then Semaglutide JEXPERIMENTALParticipants will receive subcutaneously semagutide B in treatment period 1 followed by oral semaglutide N then semaglutide J in treatment period 2.
Interventions
NameTypeDescription
Semaglutide BDRUGSemaglutide B will be administered subcutaneously.
Semaglutide JDRUGSemaglutide J will be administered as oral tablets.
Semaglutide LDRUGSemaglutide L will be administered as oral tablets.
Semaglutide MDRUGSemaglutide M will be administered as oral tablets.
Semaglutide NDRUGSemaglutide N will be administered as oral tablets.
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Eligibility Criteria
Age Range18 Years — 64 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Male. 2. Age 18-64 years (both inclusive) at the time of signing the informed consent. 3. Body mass index (BMI) between 22.0 and 31.9 kilogram per square meter (kg/m\^2) (both inclusive) at screening. 4. Considered to be generally healthy based on the medical history, physica...

Countries:Canada
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