Obesity, Overweight
Conditions
Brief summary
The purpose of this study is to see how two study medicines, PF-07976016 and danuglipron, taken together affect the level of each other in the blood of participants who have overweight or obesity. The total number of weeks of the study is up to approximately 22 weeks (5.5 months).
Interventions
PF-07976016 oral tablets
PF-06882961 oral tablets
Sponsors
Study design
Intervention model description
Fixed Sequence
Eligibility
Inclusion criteria
* Male and non-pregnant, non-breastfeeding female, 18 to 65 years of age * BMI 25 to 40 kg/m2 and a total body weight \> 50 kg (110 lb) * Willing and able to comply with all study procedures including staying a research unit for up to 95 days
Exclusion criteria
* Any medical or psychiatric condition or laboratory abnormality, or recent serious illness or hospitalization, that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study including diagnosis of type 2 diabetes mellitus, type 1 or secondary forms of diabetes * Use of any prohibited prior or concomitant medication(s) * Presence of specified abnormalities on diagnostic assessments including clinical laboratory tests * A positive urine drug test. * History of alcohol abuse or repeated binge drinking and/or any other illicit drug use or dependence * Use of tobacco/nicotine containing products in excess of the equivalent of 5 cigarettes/day or 2 chews of tobacco/day
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Steady state area under the concentration-time profile for PF-07976016 | From 0 Hours to 24 Hours following steady-state dose |
| Steady state maximum observed concentration (Cmax) for PF-07976016 | From 0 Hours to 24 Hours following steady-state dose |
| Steady state area under the concentration-time profile danuglipron | From 0 Hours to 24 Hours following steady-state dose |
| Steady state maximum observed concentration (Cmax) for danuglipron | From 0 Hours to 24 Hours following steady-state dose |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with treatment emergent adverse events | First dose (Day 1) through 28-35 days after final dose (approximately 18 weeks) |
Countries
United States