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Semaglutide B

Phase 3

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

Semaglutide B development status

Highest phase Phase 3 (NCT05478252)
Phase scored for NVOPhase 1
Registered trials 4 across 1 sponsor since Feb 2022

Semaglutide B target and mechanism

Molecular targetGLP1R
Target classAgonist
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials2
Total Enrollment38

FDA Designations

No designations recorded

Semaglutide B clinical trials

Semaglutide B · 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

What is Semaglutide B?

Semaglutide B is an investigational small molecule developed by Novo Nordisk A/S for type 2 diabetes mellitus. It is a GLP1R agonist and has been studied in Phase 1 clinical trials. It is not described as an approved product and remains in clinical development.

What does Semaglutide B target?

Semaglutide B targets GLP1R, the glucagon-like peptide-1 receptor, and acts as an agonist at that receptor. GLP1R agonism is the mechanism described for this asset, which is being developed in the metabolic therapeutic area for type 2 diabetes mellitus.

Who makes Semaglutide B?

Semaglutide B is developed by Novo Nordisk A/S, which trades under the ticker NVO. Novo Nordisk is the sponsor behind the Phase 1 trials of this small molecule GLP1R agonist for type 2 diabetes mellitus.

What phase is Semaglutide B in?

Semaglutide B is in Phase 1 clinical development. Two Phase 1 trials have been completed, and no trials are currently active. The program is investigational and has not been described as approved for any indication.

What clinical trials is Semaglutide B in?

Semaglutide B has been studied in two completed Phase 1 trials: NCT05689099, which compared two concentrations of semaglutide for the 0.5 mg dose in the United States, and NCT05232708, which compared two different forms of semaglutide in the United Kingdom. Together they enrolled 38 participants.