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
NCT ID: NCT06567327
Last Updated: 2025-08-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
82 participants
INTERVENTIONAL
2024-08-28
2025-04-14
Brief Summary
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* how the study medicine, danuglipron, is taken up into the blood
* if the study medicine, danuglipron, changes how the body processes other study medicines (Atorvastatin and Rosuvastatin)
* about the safety and tolerability of danuglipron
The study will take place in 4 Cohorts (groups). The total number of weeks of the study is about 23 (about 6 months) for Cohort 1 and 22 weeks (about 5.5 months) for Cohort 2, 21 weeks (about 5 months) for Cohort 3 and 20 weeks (about 5 months) for Cohort 4.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Cohort 1
Participants will receive a single dose of atorvastatin and multiple oral doses of danuglipron with and without atorvastatin
Danuglipron
Danuglipron oral tablets
Atorvastatin
Atorvastatin oral tablets
Cohort 2
Participants will receive a single dose of rosuvastatin and multiple oral doses of danuglipron with and without rosuvastatin
Danuglipron
Danuglipron oral tablets
Rosuvastatin
Rosuvastatin oral tablets
Cohort 3
Participants will receive a single dose of atorvastatin and multiple oral doses of danuglipron with and without atorvastatin
Danuglipron
Danuglipron oral tablets
Atorvastatin
Atorvastatin oral tablets
Cohort 4
Participants will receive a single dose of rosuvastatin and multiple oral doses of danuglipron with and without rosuvastatin
Danuglipron
Danuglipron oral tablets
Rosuvastatin
Rosuvastatin oral tablets
Interventions
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Danuglipron
Danuglipron oral tablets
Atorvastatin
Atorvastatin oral tablets
Rosuvastatin
Rosuvastatin oral tablets
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Body mass index (BMI) of ≥25.0-45.4 kg/m2; and a total body weight \>50 kg (110 lb)
Exclusion Criteria
* Any condition possibly affecting drug absorption
* Known intolerance/hypersensitivity to a GLP-1R agonist and/or known hypersensitivity or contraindication to atorvastatin (Cohort 1 and 3 participants) or rosuvastatin (Cohort 2 and 4 participants)
18 Years
64 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Anaheim Clinical Trials, LLC
Anaheim, California, United States
Qps - Mra, Llc.
South Miami, Florida, United States
Qps-Mra, Llc
South Miami, Florida, United States
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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NCT06567327
Identifier Type: REGISTRY
Identifier Source: secondary_id
C3421086
Identifier Type: -
Identifier Source: org_study_id
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