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| ID | Type | Description | Link |
|---|---|---|---|
| NCT06568731 | Registry Identifier | ClinicalTrials.gov |
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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:
The total number of weeks of the study is about 15 (about 4 months).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental | Participants will receive multiple doses of danuglipron |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Danuglipron | Drug | Danuglipron oral tablets |
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| Measure | Description | Time Frame |
|---|---|---|
| Steady-state area under the concentration-time profile from time zero to 24 hours (AUC24) for danuglipron | Predose to 24 hours post danuglipron 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants reporting Treatment Emergent Adverse Events (TEAEs) | From baseline up to 28-35 days post last dose taken | |
| Number of participants reporting clinically significant clinical laboratory abnormalities | From baseline up to 28-35 days post last dose taken |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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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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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| C000731016 | danuglipron |
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| 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 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |