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
Phase 1
Active, not recruiting
- Conditions
- Obesity
- Interventions
- Registration Number
- NCT06567327
- Lead Sponsor
- Pfizer
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 82
Inclusion Criteria
- 18 to < 65 years of age
- Body mass index (BMI) of ≥25.0-45.4 kg/m2; and a total body weight >50 kg (110 lb)
Key
Exclusion Criteria
- Evidence or history of any clinically significant medical conditions or laboratory abnormality
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cohort 1 Danuglipron Participants will receive a single dose of atorvastatin and multiple oral doses of danuglipron with and without atorvastatin Cohort 1 Atorvastatin Participants will receive a single dose of atorvastatin and multiple oral doses of danuglipron with and without atorvastatin Cohort 2 Danuglipron Participants will receive a single dose of rosuvastatin and multiple oral doses of danuglipron with and without rosuvastatin Cohort 2 Rosuvastatin Participants will receive a single dose of rosuvastatin and multiple oral doses of danuglipron with and without rosuvastatin Cohort 3 Danuglipron Participants will receive a single dose of atorvastatin and multiple oral doses of danuglipron with and without atorvastatin Cohort 3 Atorvastatin Participants will receive a single dose of atorvastatin and multiple oral doses of danuglipron with and without atorvastatin Cohort 4 Danuglipron Participants will receive a single dose of rosuvastatin and multiple oral doses of danuglipron with and without rosuvastatin Cohort 4 Rosuvastatin Participants will receive a single dose of rosuvastatin and multiple oral doses of danuglipron with and without rosuvastatin
- Primary Outcome Measures
Name Time Method Steady-state maximum observed concentration (Cmax) 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 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 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 to the time of the last quantifiable concentration (AUClast) for rosuvastatin (only if AUCinf is not reportable) Predose to 96 hours post rosuvastatin administration
- Secondary Outcome Measures
Name Time Method Number of participants reporting clinically significant clinical laboratory abnormalities From baseline up to 28-35 days post last dose taken Number of participants reporting clinically significant changes ECG abnormalities From baseline up to 28-35 days post last dose taken Number of participants reporting clinically significant vital sign abnormalities From baseline up to 28-35 days post last dose taken Change from baseline in body weight From baseline up to 28-35 days post last dose taken Number of participants reporting Treatment Emergent Adverse Events (TEAEs) From baseline up to 28-35 days post last dose taken
Trial Locations
- Locations (3)
Qps - Mra, Llc.
🇺🇸South Miami, Florida, United States
Anaheim Clinical Trials, LLC
🇺🇸Anaheim, California, United States
Qps-Mra, Llc
🇺🇸South Miami, Florida, United States