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PF-06954522

Phase 1

Type 2 Diabetes Mellitus (T2DM) | Small molecule | Metabolic |Pfizer, Inc.|Last Updated: Jun 3, 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 Enrollment50
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06279234A Study to Learn How Different Amounts of PF-06954522 Are Tolerated and Act in Adults With Type 2 Diabetes MellitusPHASE1 COMPLETED 50 — — Feb 20, 2024Apr 11, 2025Jun 3, 20252 United States
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Study Endpoints
Primary Endpoints
Number of Participants Reporting Adverse Events
Baseline through Week 14
Number of Participants with Clinically Significant Change From Baseline in Laboratory Abnormalities
Baseline through Week 14
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Baseline through Week 14
Number of Participants With Clinically Significant Change From Baseline in 12-Lead ECGs
Baseline through Week 14
Number of Participants with categorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Baseline through Week 14
Secondary Endpoints
Maximum Observed Plasma Concentration (Cmax)
Part A: Days -1, 1, 14, 21 & 28. Days 2, 4, 7, 10, 17, 20, 24, 30. Part A & B: Days -1, 1, 28, 49 & 56. Days 7, 14, 21, 35, 42, 57 & 58. Part C: Period 3 Day 3 & Period 5 Day 28
Area Under the Curve from Time Zero to end of dosing interval (AUCtau)
Part A: Days -1, 1, 14, 21 & 28. Days 2, 4, 7, 10, 17, 20, 24, 30. Part A & B: Days -1, 1, 28, 49 & 56. Days 7, 14, 21, 35, 42, 57, 58. Part C: Period 3 Day 3 & Period 5 Day 28
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Part A: Days -1, 1, 14, 21 & 28. Days 2, 4, 7, 10, 17, 20, 24 & 30. Part A & B: Day -1, 1 28, 49 & 56. Days 7, 14, 21, 35, 42, 57 & 58. Part C: Period 3 Day 3 & Period 5 Day 28
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Part AEXPERIMENTALMultiple doses of PF 06954522 or placebo daily for up to 8 weeks in adult participants with T2DM in up to 7 cohorts.
Part B (Optional)EXPERIMENTALMultiple doses of PF 06954522 or placebo daily for up to 8 weeks in non-diabetic adult participants with obesity in up to 3 cohorts.
Part C (Optional)EXPERIMENTALAn 8-period multiple-dose assessment of the effect of PF-06954522 on rosuvastatin, midazolam, and omeprazole PK in healthy adult participants for up to 14 weeks in healthy adult participants.
Interventions
NameTypeDescription
PlaceboDRUGOral tablet
RosuvastatinDRUGOral tablet
MidazolamDRUGOral suspension
OmeprazoleDRUGOral tablet
PF-06954522DRUGOral tablet
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Female participants of non-childbearing potential and males between the ages of 18 and 70 years, inclusive, at the time of signing the ICD. * Part A only: Diagnosis of Diabetes - Participants enrolling with T2DM must have a clinical history of T2DM and be taking metformin mono...

Countries:United States
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