Drug Interaction, Obesity, Overweight, Overweight and/or Obesity
Conditions
Brief summary
This study looks at how a study medicine called PF-08653944 affects how quickly the stomach empties food after eating. It is being done in adults who are overweight or have obesity. Participants will receive the study medicine for a short period, and doctors will measure how the medicine moves through the stomach and monitor safety. The goal is to better understand how this medicine works in the body and to check for any side effects. The information from this study may help researchers plan future studies of this medicine.
Interventions
Subcutaneous Injection
Oral suspension
Sponsors
Study design
Eligibility
Inclusion criteria
* Adults ≥18 years at screening, male or female, generally healthy as determined by medical history, physical examination, laboratory tests, and ECG. * Body mass index (BMI) 27-45 kg/m² and body weight \>50 kg (110 lb). * Participants with overweight or obesity
Exclusion criteria
* History or presence of clinically significant medical conditions, including but not limited to: --Cardiovascular, hepatic, renal, pulmonary, endocrine, hematologic, neurologic, gastrointestinal (including pancreatitis or gallbladder disease), or significant psychiatric disorders. * Any form of diabetes, HbA1c ≥6.5%, or fasting plasma glucose ≥126 mg/dL. * Prior exposure to a GLP-1 receptor agonist within 90 days before first dose, or prior participation in a study with PF-08653944.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acetaminophen Pharmacokinetic (PK) Parameters: Maximum observed plasma concentration (Cmax) | Day 1 pre-dose through approximately 11 Weeks after last dose of study intervention. | To assess the effect of multiple SC doses of PF-08653944 on the plasma PK profile of acetaminophen, a marker for gastric emptying, in healthy adult participants with overweight or obesity. |
| Acetaminophen PK parameters: Area under the plasma concentration (AUC) | Day 1 pre-dose through approximately 11 Weeks after last dose of study intervention. | To assess the effect of multiple SC doses of PF-08653944 on the plasma PK profile of acetaminophen, a marker for gastric emptying, in healthy adult participants with overweight or obesity. |
| Acetaminophen PK parameters: Time to Maximum concentration (Tmax) | Day 1 pre-dose through approximately 11 Weeks after last dose of study intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with Treatment Emergent Adverse Events (TEAEs) | First dose through study completion, approximately 11 Weeks post last dose. |
Countries
United States
Contacts
Pfizer