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PF-07976016

Phase 2

Obesity | Small molecule | Metabolic |Pfizer, Inc.|Last Updated: Feb 6, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment263

FDA Designations

No designations recorded

Clinical trial landscape

PF-07976016 · 3 trials · 3 indications

Phase 2 1Phase 1 2
NCT06717425A Study to Learn About the Study Medicine Called PF-07976016 in Adults With ObesityObesity
COMPLETED263 Analytics
PHASE2COMPLETED
A Study to Learn About the Study Medicine Called PF-07976016 in Adults With Obesity
ObesityUnlock trial analytics

Study Endpoints

Primary Endpoints

Percent change from baseline in body weight
Baseline to Week 16
Total recovery of radioactivity expressed as a percent of total oral radioactive dose administered.
From dose (Day 1) and for up to 21 days thereafter
Part A: Number of Participants With Treatment Emergent Adverse Events Following Single Doses
Day 1 up to approximately Day 36
Part A: Number of Participants With Clinical Laboratory Abnormalities Following Single Doses
Day 1 up to approximately Day 36
Part A: Number of Participants With Clinically Significant Change in Baseline Vital Signs Following Single Doses
Day 1 up to approximately Day 36
Part A: Number of Participants With Clinically Significant Change from Baseline in Electrocardiogram Findings Following Single Doses
Day 1 up to approximately Day 36
Part B, Parts C and D, if conducted: Number of Participants With Treatment Emergent Adverse Events Following Multiple Doses
Day 1 up to approximately Day 49
Part B, Parts C and D, if conducted: Number of Participants With Clinical Laboratory Abnormalities Following Multiple Doses
Day 1 up to approximately Day 49
Part B, Parts C and D, if conducted: Number of Participants With Clinically Significant Change in Baseline Vital Signs Following Multiple Doses
Day 1 up to approximately Day 49
Part B, Parts C and D, if conducted: Number of Participants With Clinically Significant Change from Baseline in Electrocardiogram Findings Following Multiple Doses
Day 1 up to approximately Day 49

Secondary Endpoints

Number of participants with treatment emergent adverse events
From first dose (Day 1) up to 28-35 days after final dose, a total of approximately 21 weeks
Part A: Area Under the Plasma Concentration-time Curve from Time 0 to the Time of the Last Quantifiable Concentration
Day 1 up to Day 4
Part A: Maximum Observed Plasma Concentration
Day 1 up to Day 4
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PF-07976016 Dose 1EXPERIMENTAL -
PF-07976016 Dose 2EXPERIMENTAL -
PF-07976016 Dose 3EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Arm 1EXPERIMENTALParticipants will receive doses of PF-07976016 with and without radiolabel.
Part A Cohort 1EXPERIMENTALSingle dose administration of PF-07976016 and placebo. Participants will receive up to 4 dose levels of PF-07976016 or matching placebo.
Part A Cohort 2EXPERIMENTALSingle dose administration of PF-07976016 and placebo. Participants will receive up to 4 dose levels of PF-07976016 or matching placebo.
Part A Optional Cohort 3EXPERIMENTALSingle dose administration of PF-07976016 and placebo. Participants will receive up to 2 dose levels of PF-07976016 or matching placebo.
Part A Optional Cohort 4EXPERIMENTALSingle dose administration of PF-07976016 and placebo. Participants will receive up to 4 dose levels of PF-07976016 or matching placebo.
Part B Cohort 5EXPERIMENTALMultiple dose administration of PF-07976016 or matching placebo.
Part B Cohort 6EXPERIMENTALMultiple dose administration of PF-07976016 or matching placebo.
Part B Cohort 7EXPERIMENTALMultiple dose administration of PF-07976016 or matching placebo.
Part B Cohort 8EXPERIMENTALMultiple dose administration of PF-07976016 or matching placebo.
Part B Cohort 9EXPERIMENTALMultiple dose administration of PF-07976016 or matching placebo.
Part B Optional Cohort 10EXPERIMENTALMultiple dose administration of PF-07976016 or matching placebo.
Part C Optional Cohort 11EXPERIMENTALSingle dose midazolam administered alone or in combination with multiple doses of PF-07976016.
Part C Optional Cohort 12EXPERIMENTALSingle dose midazolam administered alone or in combination with multiple doses of PF-07976016.
Part D Optional Cohort 13EXPERIMENTALMultiple dose administration of PF-07976016 or matching placebo.

Interventions

NameTypeDescription
PF-07976016DRUGTaken once daily
PlaceboDRUGTaken once daily
[14C] PF-07976016DRUG\[14C\] PF-07976016 liquid (oral) formulation
MidazolamDRUGMidazolam oral solution
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Eligibility Criteria

Age Range18 Years to 74 Years
SexALL
Healthy VolunteersNo
Study Sites38

Key Inclusion Criteria: * Male or non-pregnant, non-breastfeeding female, 18 to 74 years of age at Visit 1 * Body Mass Index ≥30.0 kg/m2 at Visit 1, with stable body weight, defined as \<5 kg change in the 12 weeks before Visit 1 * Eligible and willing to receive required background medicine * Will...

Countries:United StatesCanadaPolandNetherlands
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Frequently asked questions about PF-07976016

What is PF-07976016 used for?

PF-07976016 is an investigational small molecule being studied for the treatment of obesity and for use in healthy adults and healthy male volunteers. It is being developed by Pfizer, Inc. and has completed clinical trials in these populations.

Who makes PF-07976016?

PF-07976016 is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is an investigational small molecule in clinical development.

What phase is PF-07976016 in?

PF-07976016 is in clinical development. It has completed a Phase 1 study in healthy adults, a Phase 1 study in healthy male volunteers, and a Phase 2 study in adults with obesity. All three trials are completed.

What clinical trials is PF-07976016 in?

PF-07976016 has been studied in three completed clinical trials. NCT06106009 was a Phase 1 trial in healthy adults in the United States. NCT06717425 was a Phase 2 trial in adults with obesity in the United States, Canada, and Poland. NCT07015918 was a Phase 1 trial in healthy male volunteers in the Netherlands.

Is PF-07976016 FDA approved?

PF-07976016 is an investigational drug and is not FDA approved. It is still in clinical development, with completed Phase 1 and Phase 2 trials. The drug is being studied for obesity and in healthy volunteers.

How does PF-07976016 work?

PF-07976016 is a small molecule being developed by Pfizer, Inc. Its molecular target has not been disclosed in the available clinical trial information. The drug is being studied for its effects in obesity and in healthy volunteers.