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semaglutide

Phase 3

Type 2 Diabetes | Small molecule | Metabolic |Novo Nordisk A/S|Last Updated: Mar 31, 2026

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 Enrollment264
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07271251A Research Study to See if Two Different Formulations of Oral Semaglutide Are Equally Safe and Effective in Reducing the Blood Sugar Level in Japanese People With Type 2 DiabetesPHASE3 ACTIVE NOT_RECRUITING 264 — — Dec 1, 2025Aug 3, 2026Mar 31, 202615 Japan
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Study Endpoints
Primary Endpoints
Change in glycated haemoglobin (HbA1c).
From baseline (week 0) to end of treatment (week 20)

Measured in percentage (%)-point.

Secondary Endpoints
Change in body weight
From baseline (week 0) to end of treatment (week 20)
Number of treatment emergent adverse events (TEAEs)
From baseline (week 0) to end of study (week 25)
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Oral semaglutide DEXPERIMENTALParticipants will receive oral semaglutide D once daily.
Oral semaglutideEXPERIMENTALParticipants will receive oral semaglutide once daily.
Interventions
NameTypeDescription
Oral semaglutideDRUGSemaglutide will be administered orally once daily.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites15

Inclusion Criteria: * Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study. * Japanese male or female. * Age 18 years or above at the time of ...

Countries:Japan
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Competitive Landscape -Type 2 Diabetes 151 trials
CompanyTickerTrialsLead PhaseDrugs
Eli Lilly and CompanyLLY18PHASE3Retatrutide, Semaglutide, Orforglipron, Dulaglutide, Tirzepatide
Amgen Inc.AMGN4PHASE3Maridebart cafraglutide, Maridebart Cafraglutide, AMG 127
Novo Nordisk A/S Sponsored ADR Class BNVO23PHASE3semaglutide, Cagrilintide, Semaglutide, Tirzepatide, CagriSema
Pfizer Inc.PFE1PHASE3PF-08653944
Oramed Pharmaceuticals IncorporatedORMP1PHASE3ORMD-0801
ProKidney Corp. Class APROK1PHASE3Renal Autologous Cell Therapy
NewAmsterdam Pharma Company N.V.NAMS1PHASE3obicetrapib + ezetimibe daily
AstraZeneca PLCAZN3PHASE2AZD6234
Alnylam Pharmaceuticals, IncALNY2PHASE2ALN-4324
MediciNova, Inc.MNOV1PHASE2MN-001
Arrowhead Pharmaceuticals, Inc.ARWR1PHASE1ARO-ALK7
MannKind CorporationMNKD1PHASE2Technosphere Insulin
Merck & Co., Inc.MRK1PHASE1MK-1403 + additive coformulation
Insulet CorporationPODD5NAUndisclosed
Abbott LaboratoriesABT7NAUndisclosed
Biomea Fusion IncBMEA2PHASE2icovamenib
Milestone Pharmaceuticals, Inc.MIST2PHASE2CX11
Unity Health TorontoUBX1PHASE3Undisclosed
DexCom, Inc.DXCM6NAUndisclosed
Design Therapeutics, Inc.DSGN1PHASE2Farxiga + Onglyza + Metformin Mix Treat type 2 diabetes, China Import + China Import + Metformin Mix Treat type 2 diabetes
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Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT07271251Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWMay 24, 2026NCT07271251studyFirstPostDate: changed