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Danuglipron

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Aug 6, 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment16

FDA Designations

No designations recorded

Clinical trial landscape

Danuglipron · 4 trials · 4 indications

Phase 1 4
NCT06541678A Study to Learn if the Study Medicines Called Itraconazole and Cyclosporine Change How the Body Processes the Other Study Medicine Called Danuglipron in Healthy Adults.Healthy
COMPLETED16 Analytics
NCT06567327A Study to Learn How the Study Medicine Danuglipron is Taken Up Into the Blood and If Danuglipron Changes How the Body Processes Other Study Medicines (Atorvastatin and Rosuvastatin) in Healthy Adults Who Are Overweight or ObeseObesity
COMPLETED82 Analytics
NCT06568731A Study to Learn How Different Amounts of the Study Medicine Danuglipron Are Taken up Into the Blood in Otherwise Healthy Adults With Overweight or ObesityObesity
COMPLETED23 Analytics
NCT06153758Study to Learn How Different Forms of The Study Medicine Called Danuglipron Are Taken up Into the Blood In Healthy AdultsHealthy Participants
COMPLETED33 Analytics
PHASE1COMPLETED
A Study to Learn if the Study Medicines Called Itraconazole and Cyclosporine Change How the Body Processes the Other Study Medicine Called Danuglipron in Healthy Adults.
Healthy
NCT0654167816
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PHASE1COMPLETED
A Study to Learn How the Study Medicine Danuglipron is Taken Up Into the Blood and If Danuglipron Changes How the Body Processes Other Study Medicines (Atorvastatin and Rosuvastatin) in Healthy Adults Who Are Overweight or Obese
Obesity
NCT0656732782
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PHASE1COMPLETED
A Study to Learn How Different Amounts of the Study Medicine Danuglipron Are Taken up Into the Blood in Otherwise Healthy Adults With Overweight or Obesity
Obesity
NCT0656873123
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PHASE1COMPLETED
Study to Learn How Different Forms of The Study Medicine Called Danuglipron Are Taken up Into the Blood In Healthy Adults
Healthy Participants
NCT0615375833
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Study Endpoints

Primary Endpoints

AUCinf (if data permits otherwise AUClast): to estimate the effect of a single dose of cyclosporine on the single-dose PK of a MR formulation of danuglipron in healthy adult participants.
0 to 72 hour postdose

AUCinf: Area under the plasma concentration time profile from time zero extrapolated to infinite time AUClast: Area under the plasma concentration time profile from time zero to the time of the last quantifiable concentration.

Cmax: to estimate the effect of a single dose of cyclosporine on the single-dose PK of a MR formulation of danuglipron in healthy adult participants.
0 to 72 hour postdose

Maximum observed plasma concentration

AUCinf (if data permits otherwise AUClast): to estimate the effect of multiple doses of itraconazole on the single-dose PK of a MR formulation of danuglipron in healthy adult participants.
0 to 72 hour postdose

AUCinf: Area under the plasma concentration time profile from time zero extrapolated to infinite time AUClast: Area under the plasma concentration time profile from time zero to the time of the last quantifiable concentration.

Cmax: to estimate the effect of multiple doses of itraconazole on the single-dose PK of a MR formulation of danuglipron in healthy adult participants.
0 to 72 hour postdose

Maximum observed plasma concentration

Steady-state area under the concentration-time profile from time zero to 24 hours (AUC24) for danuglipron
Predose to 24 hours post danuglipron administration
Steady-state maximum observed concentration (Cmax) for danuglipron
Predose to 24 hours post danuglipron administration
Steady-state time to reach maximum observed concentration (Tmax) for danuglipron
Predose to 24 hours post danuglipron administration
Area under the concentration-time curve from time zero extrapolated to infinite time (AUCinf), as data permit, for atorvastatin
Predose to 72 hours post atorvastatin administration
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) for atorvastatin (only if AUCinf is not reportable)
Predose to 72 hours post atorvastatin administration
Area under the concentration-time curve from time zero extrapolated to infinite time (AUCinf), as data permit, for rosuvastatin
Predose to 96 hours post rosuvastatin administration
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) for rosuvastatin (only if AUCinf is not reportable)
Predose to 96 hours post rosuvastatin administration
Parts A, C and D only: Area under the concentration-time curve from time zero extrapolated to infinite time (AUCinf), as data permit, for danuglipron in the fasted state
Predose to 48 hours post danuglipron administration
Parts A, C and D only: Maximum observed concentration (Cmax) for danuglipron in the fasted state
Predose to 48 hours post danuglipron administration
Parts A, C and D only: Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) for danuglipron (only if AUCinf is not reportable) in the fasted state
Predose to 48 hours post danuglipron administration
Part B only: Dose normalized area under the concentration-time curve from time zero extrapolated to infinite time (AUCinf,dn), as data permit, for danuglipron in the fasted state
Predose to 48 hours post danuglipron administration
Part B only: Dose normalized maximum observed concentration (Cmax,dn) for danuglipron in the fasted state
Predose to 48 hours post danuglipron administration
Part B only: Dose normalized area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast,dn) for danuglipron (only if AUCinf,dn is not reportable) in the fasted state
Predose to 48 hours post danuglipron administration

Secondary Endpoints

Number of Participants With Treatment Emergent Adverse Events Following Single Doses of Danuglipron administered separately and in combination with itraconazole or cyclosporine
Day 1 up to approximately Day 47
Number of Participants With Clinical Laboratory Abnormalities Following Single Doses of Danuglipron administered separately and in combination with itraconazole or cyclosporine
Day 1 up to approximately Day 47
Number of Participants With Clinically Significant Change from Baseline Vital Signs Following Single Doses of Danuglipron administered separately and in combination with itraconazole or cyclosporine
Day 1 up to approximately Day 47
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Period 1: DanuglipronACTIVE_COMPARATORParticipants will receive a single 20 mg dose of danuglipron on Day 1.
Period 2: Cyclosporine + DanuglipronEXPERIMENTALParticipants will receive a single 20 mg dose of danuglipron and a single 600 mg dose of cyclosporine on Day 1.
Period 3: Itraconazole + DanuglipronEXPERIMENTALParticipants will receive itraconazole daily for 6 days plus a single dose of danuglipron on Day 4.
Cohort 1EXPERIMENTALParticipants will receive a single dose of atorvastatin and multiple oral doses of danuglipron with and without atorvastatin
Cohort 2EXPERIMENTALParticipants will receive a single dose of rosuvastatin and multiple oral doses of danuglipron with and without rosuvastatin
Cohort 3EXPERIMENTALParticipants will receive a single dose of atorvastatin and multiple oral doses of danuglipron with and without atorvastatin
Cohort 4EXPERIMENTALParticipants will receive a single dose of rosuvastatin and multiple oral doses of danuglipron with and without rosuvastatin
Single ArmEXPERIMENTALParticipants will receive multiple doses of danuglipron
Part AEXPERIMENTALParticipants will receive a single oral dose of danuglipron on Day 1 of each period
Part BEXPERIMENTALParticipants will receive a single oral dose of danuglipron on Day 1 of each period
Part CEXPERIMENTALParticipants will receive a single oral dose of danuglipron on Day 1 of each period
Part DEXPERIMENTALParticipants will receive a single oral dose of danuglipron on Day 1 of each period

Interventions

NameTypeDescription
DanuglipronDRUGMR Tablet
CyclosporineDRUGCapsule
ItraconazoleDRUGOral solution
AtorvastatinDRUGAtorvastatin oral tablets
RosuvastatinDRUGRosuvastatin oral tablets
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Male and female 18 years of age or older (or the minimum age of consent in accordance with local regulations) at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, blood pressure, pulse rate...

Countries:United States
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Frequently asked questions about Danuglipron

What is Danuglipron used for?

Danuglipron is an investigational small molecule being studied in healthy participants and in adults with overweight or obesity. It is being evaluated for how it is absorbed into the blood and how it interacts with other medicines. It is not approved and remains in clinical development.

Who makes Danuglipron?

Danuglipron is being developed by Pfizer, Inc., whose stock trades under the ticker PFE. The company is conducting Phase 1 clinical trials of the drug in the United States.

What phase is Danuglipron in?

Danuglipron is in Phase 1 clinical development. All four of its trials are completed, with no active trials currently listed. It is an investigational drug and has not been approved by regulatory authorities.

What clinical trials is Danuglipron in?

Danuglipron has four completed Phase 1 trials: NCT06153758, NCT06541678, NCT06567327, and NCT06568731. These studies examine its absorption, drug interactions, and effects in healthy adults and those with overweight or obesity.

Is Danuglipron the same as other drugs?

Danuglipron is a distinct investigational small molecule developed by Pfizer. No alternative names for the drug have been reported in its clinical trial records. It is being studied specifically for its pharmacokinetic properties and interactions.