Recent Updates
Recently added Catalysts

PF-06954522

Phase 1

Type 2 Diabetes Mellitus (T2DM) | Small molecule | Metabolic |Pfizer, Inc.|Trials Updated: Jun 3, 2025

PF-06954522 development status

Highest phase Phase 1
Registered trials 2 across 1 sponsor since Aug 2023

PF-06954522 target and mechanism

ModalitySmall molecule

Also known as PF-06954522 MR (Formulation 2)

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment50

FDA Designations

No designations recorded

PF-06954522 clinical trials

PF-06954522 · 1 trial · 2 indications

Phase 1 1
NCT06279234A Study to Learn How Different Amounts of PF-06954522 Are Tolerated and Act in Adults With Type 2 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)
COMPLETED50 Analytics
PHASE1COMPLETED
A Study to Learn How Different Amounts of PF-06954522 Are Tolerated and Act in Adults With Type 2 Diabetes Mellitus
Type 2 Diabetes Mellitus (T2DM)Unlock trial analytics

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
Unlock Study Endpoints

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
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 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
Unlock Eligibility Criteria

Frequently asked questions about PF-06954522

What is PF-06954522?

PF-06954522 is an investigational small molecule developed by Pfizer, Inc. for Type 2 Diabetes Mellitus. It is in Phase 1 clinical development and has been studied in a single completed trial of 50 participants. It is not approved for any use.

What is PF-06954522 used for in Type 2 Diabetes Mellitus?

PF-06954522 is being studied for the treatment of Type 2 Diabetes Mellitus, with a completed Phase 1 trial that also enrolled participants with obesity. It is an investigational agent and has not been approved for prescribing in T2DM or any other condition.

Who makes PF-06954522?

Pfizer, Inc. (ticker PFE) is the developer of PF-06954522. The company sponsored the Phase 1 study of the compound in adults with Type 2 Diabetes Mellitus conducted in the United States.

What phase is PF-06954522 in?

PF-06954522 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no trials are currently active. The compound remains investigational and has not received regulatory approval for Type 2 Diabetes Mellitus or any other indication.

What clinical trials is PF-06954522 in?

PF-06954522 has been evaluated in one completed Phase 1 trial, NCT06279234, titled a study to learn how different amounts of PF-06954522 are tolerated and act in adults with Type 2 Diabetes Mellitus. The trial enrolled 50 participants in the United States and included a controlled, randomized design.

Is PF-06954522 the same as PF-06954522 MR (Formulation 2)?

Yes. PF-06954522 MR (Formulation 2) is an alternative name for PF-06954522, the Pfizer small molecule studied in Type 2 Diabetes Mellitus. Searches using either name refer to the same investigational compound.