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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-513679-42-00 | Registry Identifier | CTIS (EU) |
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The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called PF-07976016) for the potential treatment of obesity. The study will compare the experiences of participants taking the study medicine (PF-07976016) to those of participants who take placebo (a lookalike substance that contains no active study medicine). The aim is to measure the body's response to the study medicine, including any changes in participants' body weight and how well they tolerate the study medicine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-07976016 Dose 1 | Experimental |
| |
| PF-07976016 Dose 2 | Experimental |
| |
| PF-07976016 Dose 3 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-07976016 | Drug | Taken once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent change from baseline in body weight | Baseline to Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment emergent adverse events | From first dose (Day 1) up to 28-35 days after final dose, a total of approximately 21 weeks |
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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 | ||
| Artemis Institute for Clinical Research |
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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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This is a randomized, double-blind (investigator and participant), sponsor-open, placebo-controlled study.
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| Placebo | Drug | Taken once daily |
|
| San Diego |
| California |
| 92103 |
| United States |
| Clinical & Translational Research Center | Aurora | Colorado | 80045 | United States |
| University of Colorado Anschutz Medical Campus | Aurora | Colorado | 80045 | United States |
| Westside Center for Clinical Research | Jacksonville | Florida | 32205 | United States |
| New Horizon Research Center | Miami | Florida | 33165 | United States |
| Renstar Medical Research | Ocala | Florida | 34470 | United States |
| Renstar Medical Research | Ocala | Florida | 34471 | United States |
| St Johns Center for Clinical Research | Saint Augustine | Florida | 32086 | United States |
| Rophe Adult and Pediatric Medicine/SKYCRNG | Union City | Georgia | 30291 | United States |
| East-West Medical Research Institute | Honolulu | Hawaii | 96814 | United States |
| Cotton O'Neil Diabetes & Endocrinology | Topeka | Kansas | 66606 | United States |
| L-MARC Research Center | Louisville | Kentucky | 40213 | United States |
| Pennington Biomedical Research Center | Baton Rouge | Louisiana | 70808 | United States |
| StudyMetrix Research | City of Saint Peters | Missouri | 63303 | United States |
| Rochester Clinical Research, LLC | Rochester | New York | 14609 | United States |
| Accellacare - Wilmington | Wilmington | North Carolina | 28401 | United States |
| AMR Clinical | Norman | Oklahoma | 73069 | United States |
| Cornerstone Nutrition and Diabetes | Norman | Oklahoma | 73069 | United States |
| Capital Area Research, LLC | Camp Hill | Pennsylvania | 17011 | United States |
| Elligo Clinical Research Center | Austin | Texas | 78704 | United States |
| Texas Diabetes & Endocrinology, P.A. | Austin | Texas | 78749 | United States |
| Velocity Clinical Research, Dallas | Dallas | Texas | 75230 | United States |
| UT Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| Consano Clinical Research, LLC | Shavano Park | Texas | 78231 | United States |
| Chrysalis Clinical Research | St. George | Utah | 84790 | United States |
| Southwest Internal Medicine, PC | St. George | Utah | 84790 | United States |
| Selma Medical Associates | Winchester | Virginia | 22601 | United States |
| Ocean West Research Clinic | Surrey | British Columbia | V3Z 2N6 | Canada |
| Dawson Clinical Research Inc. | Guelph | Ontario | N1H 1B1 | Canada |
| The Wharton Medical Clinic Clinical Trials Inc. | Hamilton | Ontario | L8L 5G8 | Canada |
| Milestone Research Inc. | London | Ontario | N5W 6A2 | Canada |
| Canadian Phase Onward | Toronto | Ontario | M3J 0K2 | Canada |
| Centrum Zdrowia Metabolicznego Pawel Bogdanski | Poznan | Greater Poland Voivodeship | 60-589 | Poland |
| Medicome Sp. z o. o. | Oświęcim | Lesser Poland Voivodeship | 32-600 | Poland |
| Ekamed | Lublin | Lublin Voivodeship | 20-718 | Poland |
| Centrum Badan Klinicznych PI-House sp. z o.o. | Gdansk | Pomeranian Voivodeship | 80-546 | Poland |
| Centrum Medyczne Pratia Gdynia | Gdynia | Pomeranian Voivodeship | 81-338 | Poland |
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| 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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