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PF-08653944

Phase 3

Obesity | Small molecule | Metabolic |Pfizer, Inc.|Last Updated: Jul 22, 2026

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Trial Design
RandomizedDouble-BlindCONTROLLEDDMC
Total Trials3
Total Enrollment1,975
FDA Designations
No designations recorded
Clinical trial landscape

PF-08653944 · 5 trials · 7 indications

Phase 3 2Phase 1 3
NCT07595549A Study to Learn About the Study Medicine Called Berobenatide (PF-08653944) in People With Overweight or ObesityObesity
RECRUITING954 Analytics
NCT07400653A Study to Learn About the Study Medicine (PF-08653944) in People With Obesity or Overweight and Type 2 Diabetes (T2D)Obesity
RECRUITING999 Analytics
PHASE3RECRUITING
A Study to Learn About the Study Medicine Called Berobenatide (PF-08653944) in People With Overweight or Obesity
Obesity
NCT07595549954
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PHASE3RECRUITING
A Study to Learn About the Study Medicine (PF-08653944) in People With Obesity or Overweight and Type 2 Diabetes (T2D)
Obesity
NCT07400653999
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Study Endpoints
Primary Endpoints
Percent change from baseline in body weight
Baseline, Week 72
Pharmacokinetics (PK): Maximum observed plasma concentration (Cmax) of PF-08653944
Day 1 pre-dose through approximately 11 Weeks after last dose of study intervention.
PK: Area under the plasma concentration (AUC) of PF-08653944
Day 1 pre-dose through approximately 11 Weeks after last dose of study intervention.
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.
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of PF-08653944
Up to 85 days

To assess the relative bioavailability of SC to the thigh or upper arm compared to the abdomen

PK: Maximum Observed Concentration (Cmax) of PF-08653944
Up to 85 days

To assess the relative bioavailability of SC to the thigh or upper arm compared to the abdomen

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.
Group 1EXPERIMENTALParticipants without Hepatic Impairment (HI) will receive a single dose of PF-08653944, administered as Subcutaneous (SC) injection.
Group 2EXPERIMENTALParticipants with mild HI will receive a single dose of PF-08653944, administered as SC injection.
Group 3EXPERIMENTALParticipants with moderate HI will receive a single dose of PF-08653944, administered as SC injection.
Group 4EXPERIMENTALParticipants with severe HI will receive a single dose of PF 08653944, administered as SC 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.
Treatment 1EXPERIMENTALParticipants will receive a single subcutaneous (SC) dose of PF-08653944 on Day 1 administered to the abdomen.
Treatment 2EXPERIMENTALParticipants will receive a single SC dose of PF-08653944 on Day 1 administered to the thigh.
Treatment 3EXPERIMENTALParticipants will receive a single SC dose of PF-08653944 on Day 1 administered to the upper arm.
Treatment 4 (Optional)EXPERIMENTALJapanese participants will receive a single SC dose of PF-08653944 on Day 1 administered to the abdomen.
Interventions
NameTypeDescription
PF-08653944DRUGBy Subcutaneous Injection
PlaceboOTHERBy Subcutaneous Injection
AcetaminophenDRUGOral suspension
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Eligibility Criteria
Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites25

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 StatesJapanArgentinaBulgariaCanadaCzechiaGermanyPolandRomaniaSlovakiaSpainUnited Kingdom
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Competitive Landscape -Obesity 196 trials

Top 20 of 33 competitors

CompanyTickerTrialsLead PhaseDrugs
Amgen Inc.AMGN8PHASE3Maridebart cafraglutide
Eli Lilly and CompanyLLY42PHASE3Retatrutide
Novo Nordisk A/S Sponsored ADR Class BNVO46PHASE3Cagrilintide, Semaglutide
Rhythm Pharmaceuticals, Inc.RYTM7PHASE3Setmelanotide
Regeneron Pharmaceuticals, Inc.REGN3PHASE3Mibavademab
Pfizer Inc.PFE2PHASE3PF-08653944
Vanda Pharmaceuticals Inc.VNDA1PHASE3Tradipitant
Kailera Therapeutics, Inc.KLRA4PHASE3KAI-9531
AstraZeneca PLCAZN3PHASE2AZD6234
Structure Therapeutics, Inc. Sponsored ADRGPCR3PHASE2Undisclosed
PfizerMTSR3PHASE3MET097
Biohaven Ltd.BHVN1PHASE2Taldefgrobep Alfa
Skye Bioscience, Inc.SKYE1PHASE2Nimacimab, semaglutide
Palatin Technologies, Inc.PTN1PHASE2bremelanotide, tirzepatide
Veru IncVERU1PHASE2Enobosarm, Semaglutide weekly
Arrowhead Pharmaceuticals, Inc.ARWR2PHASE1ARO-INHBE, Tirzepatide
Alnylam Pharmaceuticals, IncALNY1PHASE1ALN-2232, Tirzepatide
Gilead Sciences, Inc.GILD1PHASE1GS-4571, Omeprazole
MBX Biosciences, Inc.MBX1PHASE1MBX 4291
AbbVie, Inc.ABBV1PHASE1ABBV-295
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Recent Changes (Last 90 Days)
LOWJul 22, 2026NCT07595549lastUpdatePostDate: changed
LOWJul 22, 2026NCT07595549lastUpdatePostDate: changed
MEDIUMJul 9, 2026NCT07508241Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMJul 9, 2026NCT07508241Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWJul 8, 2026NCT07595549lastUpdatePostDate: changed
LOWJul 8, 2026NCT07400653lastUpdatePostDate: changed
LOWJul 8, 2026NCT07595549lastUpdatePostDate: changed
LOWJul 8, 2026NCT07400653lastUpdatePostDate: changed
LOWJul 6, 2026NCT07400653lastUpdatePostDate: changed
LOWJul 6, 2026NCT07400679lastUpdatePostDate: changed
LOWJul 6, 2026NCT07400653lastUpdatePostDate: changed
LOWJul 6, 2026NCT07400679lastUpdatePostDate: changed
LOWJun 23, 2026NCT07595549Status: NOT_YET_RECRUITING → RECRUITING
LOWJun 23, 2026NCT07595549Status: NOT_YET_RECRUITING → RECRUITING
LOWMay 28, 2026NCT07595549startDate: changed
LOWMay 28, 2026NCT07595549startDate: changed
MEDIUMMay 26, 2026NCT07400653Status: NOT_YET_RECRUITING → RECRUITING
MEDIUMMay 26, 2026NCT07400679Status: RECRUITING → ACTIVE_NOT_RECRUITING