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The sponsor has made the decision to discontinue development of danuglipron (PF-06882961). As such, this study was discontinued prior to PF-06882961 administration.
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Period 1 | Experimental | Participants will receive doses of PF-07976016 with and without PF-06882961 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-07976016 | Drug | PF-07976016 oral tablets |
| |
| PF-06882961 |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment emergent adverse events | First dose (Day 1) through 28-35 days after final dose (approximately 18 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anaheim Clinical Trials, LLC | Anaheim | California | 92801 | 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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Fixed Sequence
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| Drug |
PF-06882961 oral tablets |
|
| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| 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 |
|---|---|
| C000731016 | danuglipron |
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