Obesity
Conditions
Keywords
Overweight, Obesity, Danuglipron, GLP-1, Drug-drug interaction, Overtly healthy, Atorvastatin, Rosuvastatin
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.
Interventions
DRUGDanuglipron
Danuglipron oral tablets
DRUGAtorvastatin
Atorvastatin oral tablets
DRUGRosuvastatin
Rosuvastatin oral tablets
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
Key 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| Steady-state area under the concentration-time profile from time zero to 24 hours (AUC24) for danuglipron | Predose to 24 hours post danuglipron administration |
Secondary
| Measure | Time frame |
|---|---|
| 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 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 clinically significant changes ECG abnormalities | 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 |
Countries
United States
Outcome results
None listed