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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

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment20

FDA Designations

ACCELERATED_APPROVAL

Clinical trial landscape

Semaglutide B, mL · 2 trials · 3 indications

Phase 1 2
NCT05689099A Research Trial Looking at the Comparability of 2 Different Concentrations of Semaglutide for the 0.5 Milligram (mg) DoseDiabetes Mellitus, Type 2
COMPLETED20 Analytics
NCT05232708A Clinical Trial Looking at the Comparability of 2 Different Forms of SemaglutideHealthy Volunteers (Diabetes Mellitus, Type 2)
COMPLETED18 Analytics
PHASE1COMPLETED
A Research Trial Looking at the Comparability of 2 Different Concentrations of Semaglutide for the 0.5 Milligram (mg) Dose
Diabetes Mellitus, Type 2Unlock trial analytics
PHASE1COMPLETED
A Clinical Trial Looking at the Comparability of 2 Different Forms of Semaglutide
Healthy Volunteers (Diabetes Mellitus, Type 2)Unlock trial analytics

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).

AUC0-last,sema 0.5mg: Area under the semaglutide concentration-time curve from time 0 until last quantifiable measurement after single dose of s.c. semaglutide 0.5 mg
0-840 hours after a single dose of s.c. semaglutide 0.5 mg

Measured in h\*nmol/L

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

Measured in 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.
Semaglutide B, 1.34 mg/mL followed by Semaglutide D, 1.0 mg/mLEXPERIMENTAL -
Semaglutide D, 1.0 mg/mL followed by Semaglutide B, 1.34 mg/mLEXPERIMENTAL -

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.
Semaglutide D, 1.0 mg/mLDRUGSubjects will receive single dose of 0.5 mg Semaglutide D, 1.0 mg/mL subcutaneously.
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Eligibility Criteria

Age Range18 Years to 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 StatesUnited Kingdom
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Frequently asked questions about Semaglutide B, mL

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.