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A Two-Part Phase 1, Open-Label, Fixed-Sequence Study to Evaluate the Multiple Dose Pharmacokinetics of Danuglipron Following Oral Administration and The Effects of Steady-State Danuglipron on the Pharmacokinetics of Single Oral Dose of Atorvastatin and Rosuvastatin in Otherwise Healthy Adult Participants With Overweight or Obesity
The purpose of this study is to learn the following about the study medicine, danuglipron, after multiple days of dosing in healthy adults who are overweight or obese: * 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.
Age
18 - 64 years
Sex
ALL
Healthy Volunteers
Yes
Anaheim Clinical Trials, LLC
Anaheim, California, United States
Qps - Mra, Llc.
South Miami, Florida, United States
Qps-Mra, Llc
South Miami, Florida, United States
Start Date
August 28, 2024
Primary Completion Date
March 16, 2025
Completion Date
April 14, 2025
Last Updated
August 6, 2025
82
ACTUAL participants
Danuglipron
DRUG
Atorvastatin
DRUG
Rosuvastatin
DRUG
Lead Sponsor
Pfizer
NCT07472881
NCT01143454
Data Source & Attribution
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