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| ID | Type | Description | Link |
|---|---|---|---|
| MET097-25-106 | Other Identifier | Alias Study Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Period 1 | Experimental | Participants will receive a single oral dose of acetaminophen. |
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| Period 2 | Experimental | Participants will receive SC dose of PF-08653944 and single oral dose of acetaminophen. |
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| Period 3 | Experimental | Participants will receive SC dose of PF-0865394. |
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| Period 4 | Experimental | Participants will receive SC dose of PF-0865394. |
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| Period 5 | Experimental | Participants will receive SC dose of PF-08653944 and single oral dose of acetaminophen. |
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| Period 6 | Experimental | Participants will receive single SC dose of PF-08653944 and single oral dose of acetaminophen. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-08653944 | Drug | Subcutaneous Injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acetaminophen Pharmacokinetic (PK) Parameters: Maximum observed plasma concentration (Cmax) | 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. | Day 1 pre-dose through approximately 11 Weeks after last dose of study intervention. |
| Acetaminophen PK parameters: Area under the plasma concentration (AUC) | 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. | Day 1 pre-dose through approximately 11 Weeks after last dose of study intervention. |
| Acetaminophen PK parameters: Time to Maximum concentration (Tmax) | Day 1 pre-dose through approximately 11 Weeks after last dose of study intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Treatment Emergent Adverse Events (TEAEs) | First dose through study completion, approximately 11 Weeks post last dose. |
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Inclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Clinical Research Unit - New Haven | New Haven | Connecticut | 06511 | United States |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| Acetaminophen | Drug | Oral suspension |
|
|
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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