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PF-08653945

Phase 2

Overweight | Small molecule | Metabolic |Pfizer, Inc.|Last Updated: May 8, 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
RandomizedDouble-BlindCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment872
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07575932A Study of PF-08653945 and PF-08653944 in Adults With Overweight or Obesity (SOLIS-1)PHASE2 NOT YET_RECRUITING 872 — — May 11, 2026Jan 5, 2028May 8, 20263 United States
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Study Endpoints
Primary Endpoints
Percent change from baseline in body weight
Baseline (Week 0) to Week 48
Secondary Endpoints
Percent change from baseline in body weight
Baseline (Week 0) to Week 60
Change from baseline in body weight
Baseline (Week 0) to Week 48 and Week 60
Percentage of participants who achieve ≥5% of body weight reduction from baseline
Baseline (Week 0) to Week 48 and Week 60
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cohort 1EXPERIMENTALParticipants receive subcutaneous injections of PF-08653945 or placebo.
Cohort 2EXPERIMENTALParticipants receive subcutaneous injections of PF-08653945 + PF-08653944 or placebo.
Cohort 3EXPERIMENTALParticipants receive subcutaneous injections of PF-08653945 + PF-08653944 , PF-08653944 , or placebo.
Interventions
NameTypeDescription
PF-08653945DRUGSubcutaneous Injection
PF-08653944DRUGSubcutaneous Injection
PlaceboDRUGSubcutaneous Injection
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: Eligible participants for this study include: * adults aged 18 years or older with * obesity (BMI of 30.0 kg/m2 to 50.0 kg/m2) or with * overweight (BMI of 27.0 kg/m2 to \<30.0 kg/m2) who also have at least 1 prespecified weight-related comorbidity (hypertension, dyslipidemia, ...

Countries:United States
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