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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

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment90

FDA Designations

ACCELERATED_APPROVAL

Clinical trial landscape

Semaglutide B · 1 trial · 1 indication

Phase 1 1
NCT06642584A Research Study Looking at New Protein-based Tablets in Healthy Men - Oral Formulation IVHealthy Volunteers Type 2 Diabetes
COMPLETED90 Analytics
PHASE1COMPLETED
A Research Study Looking at New Protein-based Tablets in Healthy Men - Oral Formulation IV
Healthy Volunteers Type 2 DiabetesUnlock trial analytics

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 to 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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Frequently asked questions about Semaglutide B

What is Semaglutide B used for?

Semaglutide B is an investigational small molecule being studied for Type 2 Diabetes Mellitus and in healthy volunteers. It is in Phase 1 clinical development by Novo Nordisk A/S. The drug is not approved and remains under investigation for its potential use in these metabolic conditions.

Who makes Semaglutide B?

Semaglutide B is being developed by Novo Nordisk A/S, a biopharmaceutical company traded on the stock exchange under the ticker NVO. The company is conducting early-stage clinical trials to evaluate this investigational small molecule for Type 2 Diabetes Mellitus.

What phase is Semaglutide B in?

Semaglutide B is currently in Phase 1 clinical development. It has completed three Phase 1 trials with a total enrollment of 90 participants. The drug is investigational and has not received approval, though it has been granted accelerated approval designation by the FDA.

What clinical trials is Semaglutide B in?

Semaglutide B has completed three Phase 1 trials: NCT05232708, a comparability study of two forms of semaglutide in healthy volunteers in the UK; NCT05689099, a comparability study of two concentrations in the US; and NCT06642584, a study of new protein-based tablets in healthy men in Canada.

Is Semaglutide B the same as semaglutide?

Semaglutide B is a distinct investigational drug being developed by Novo Nordisk. While it shares a name with the approved medication semaglutide, Semaglutide B is a separate small molecule in early clinical development for Type 2 Diabetes Mellitus and has not been approved for any use.