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| ID | Type | Description | Link |
|---|---|---|---|
| NCT06567327 | 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 study will take place in 4 Cohorts (groups). The total number of weeks of the study is about 23 (about 6 months) for Cohort 1 and 22 weeks (about 5.5 months) for Cohort 2, 21 weeks (about 5 months) for Cohort 3 and 20 weeks (about 5 months) for Cohort 4.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Participants will receive a single dose of atorvastatin and multiple oral doses of danuglipron with and without atorvastatin |
|
| Cohort 2 | Experimental | Participants will receive a single dose of rosuvastatin and multiple oral doses of danuglipron with and without rosuvastatin |
|
| Cohort 3 | Experimental | Participants will receive a single dose of atorvastatin and multiple oral doses of danuglipron with and without atorvastatin |
|
| Cohort 4 | Experimental | Participants will receive a single dose of rosuvastatin and multiple oral doses of danuglipron with and without rosuvastatin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Danuglipron | Drug | Danuglipron oral tablets |
|
| 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 | |
| Area under the concentration-time curve from time zero extrapolated to infinite time (AUCinf), as data permit, for atorvastatin | Predose to 72 hours post atorvastatin administration | |
| Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) for atorvastatin (only if AUCinf is not reportable) | Predose to 72 hours post atorvastatin administration | |
| Area under the concentration-time curve from time zero extrapolated to infinite time (AUCinf), as data permit, for rosuvastatin | Predose to 96 hours post rosuvastatin administration | |
| Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) for rosuvastatin (only if AUCinf is not reportable) | Predose to 96 hours post rosuvastatin 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 |
|---|---|---|---|---|---|---|
| Anaheim Clinical Trials, LLC | Anaheim | California | 92801 | United States | ||
| Qps - Mra, Llc. |
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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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| Atorvastatin | Drug | Atorvastatin oral tablets |
|
| Rosuvastatin | Drug | Rosuvastatin oral tablets |
|
| 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 |
| South Miami |
| Florida |
| 33143 |
| United States |
| Qps-Mra, Llc | South Miami | Florida | 33143 | United States |
| 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 |
|---|---|
| C000731016 | danuglipron |
| D000069059 | Atorvastatin |
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
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