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PF-08653944

Phase 3

Obesity | Small molecule | Metabolic |Pfizer, Inc.|Last Updated: May 27, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials3
Total Enrollment1,973
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07595549A Study to Learn About the Study Medicine Called Berobenatide (PF-08653944) in People With Overweight or ObesityPHASE3 NOT YET_RECRUITING 954Jun 30, 2026Jun 21, 2028May 27, 2026 -
NCT07400653A Study to Learn About the Study Medicine (PF-08653944) in People With Obesity or Overweight and Type 2 Diabetes (T2D)PHASE3 RECRUITING 999Feb 24, 2026May 16, 2028May 18, 2026183 United States, Argentina +9
NCT07508241A Study to Learn About the Effect of Study Medicine Called PF-08653944 on How Quickly the Stomach Empties Its Content in Healthy Adults With Overweight or ObesityPHASE1 RECRUITING 20Mar 31, 2026Jan 27, 2027Apr 23, 20261 United States
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Study Endpoints
Primary Endpoints
Percent change from baseline in body weight
Baseline, Week 72
Acetaminophen Pharmacokinetic (PK) Parameters: Maximum observed plasma concentration (Cmax)
Day 1 pre-dose through approximately 11 Weeks after last dose of study intervention.

To assess the effect of multiple SC doses of PF-08653944 on the plasma PK profile of acetaminophen, a marker for gastric emptying, in healthy adult participants with overweight or obesity.

Acetaminophen PK parameters: Area under the plasma concentration (AUC)
Day 1 pre-dose through approximately 11 Weeks after last dose of study intervention.

To assess the effect of multiple SC doses of PF-08653944 on the plasma PK profile of acetaminophen, a marker for gastric emptying, in healthy adult participants with overweight or obesity.

Acetaminophen PK parameters: Time to Maximum concentration (Tmax)
Day 1 pre-dose through approximately 11 Weeks after last dose of study intervention.
Secondary Endpoints
Change from baseline in body weight
Baseline, Week 72
Change from baseline in waist circumference
Baseline, Week 72
Percentage of Participants achieving ≥5% of body weight reduction from baseline
Baseline, Week 72
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Treatment Arm 1EXPERIMENTALParticipants will receive PF-08653944 by Subcutaneous Injection.
Treatment Arm 2EXPERIMENTALParticipants will receive PF-08653944 by Subcutaneous Injection.
Treatment Arm 3EXPERIMENTALParticipants will receive PF-08653944 by Subcutaneous Injection.
Treatment Arm 4EXPERIMENTALParticipants will receive PF-08653944 by Subcutaneous Injection.
PlaceboPLACEBO_COMPARATORParticipants will receive matching placebo by Subcutaneous Injection.
Period 1EXPERIMENTALParticipants will receive a single oral dose of acetaminophen.
Period 2EXPERIMENTALParticipants will receive SC dose of PF-08653944 and single oral dose of acetaminophen.
Period 3EXPERIMENTALParticipants will receive SC dose of PF-0865394.
Period 4EXPERIMENTALParticipants will receive SC dose of PF-0865394.
Period 5EXPERIMENTALParticipants will receive SC dose of PF-08653944 and single oral dose of acetaminophen.
Period 6EXPERIMENTALParticipants will receive single SC dose of PF-08653944 and single oral dose of acetaminophen.
Interventions
NameTypeDescription
PF-08653944DRUGBy Subcutaneous Injection
PlaceboOTHERBy Subcutaneous Injection
AcetaminophenDRUGOral suspension
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Aged ≥18 years. * BMI of: ≥30 kg/m2 or ≥27.0 kg/m2 to \<30.0 kg/m2 and must have at least 1 of the following weight-related co-morbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease, or T2D. Exclusion Criteria: * Have a self-reported body we...

Countries:United StatesArgentinaBulgariaCanadaCzechiaGermanyPolandRomaniaSlovakiaSpainUnited Kingdom
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Recent Changes (Last 90 Days)
LOWMay 28, 2026NCT07595549startDate: changed
LOWMay 28, 2026NCT07595549startDate: changed
MEDIUMMay 26, 2026NCT07400653Status: NOT_YET_RECRUITING → RECRUITING
LOWMay 24, 2026NCT07595549studyFirstPostDate: changed
LOWMay 24, 2026NCT07400653studyFirstPostDate: changed
LOWMay 21, 2026NCT07595549NEW_TRIAL: changed
LOWMay 21, 2026NCT07595549NEW_TRIAL: changed