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| ID | Type | Description | Link |
|---|---|---|---|
| SOLIS-1 | Other Identifier | Alias Study Number |
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This study is being done to learn about the safety and effects of the study drugs, PF-08653945 and PF-08653944, when given alone or together for weight loss, compared to a placebo (a dummy drug that has no active ingredient in it).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Participants receive subcutaneous injections of PF-08653945 or placebo. |
|
| Cohort 2 | Experimental | Participants receive subcutaneous injections of PF-08653945 + PF-08653944 or placebo. |
|
| Cohort 3 | Experimental | Participants receive subcutaneous injections of PF-08653945 + PF-08653944 , PF-08653944 , or placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-08653945 | Drug | Subcutaneous Injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change from baseline in body weight | Baseline (Week 0) to Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change from baseline in body weight | Baseline (Week 0) to Week 60 | |
| Change from baseline in body weight | Baseline (Week 0) to Week 48 and Week 60 | |
| Percentage of participants who achieve ≥5% of body weight reduction from baseline |
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Inclusion Criteria:
Eligible participants for this study include:
Exclusion Criteria:
Participants who are not eligible include those with diabetes mellitus, a body weight change of >5% or use of weight loss medications in the 12 weeks prior to screening, a history of or plan for surgical treatment for obesity, and those who are unable or unwilling to comply with contraceptive requirements or are pregnant or lactating.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pfizer CT.gov Call Center | Contact | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Clinical Trials-Chandler | Recruiting | Chandler | Arizona | 85225 | 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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| PF-08653944 |
| Drug |
Subcutaneous Injection |
|
| Placebo | Drug | Subcutaneous Injection |
|
| Baseline (Week 0) to Week 48 and Week 60 |
| Percentage of participants who achieve ≥10% of body weight reduction from baseline | Baseline (Week 0) to Week 48 and Week 60 |
| Percentage of participants who achieve ≥15% of body weight reduction from baseline | Baseline (Week 0) to Week 48 and Week 60 |
| Percentage of participants who achieve ≥20% of body weight reduction from baseline | Baseline (Week 0) to Week 48 and Week 60 |
| Percentage of participants who achieve ≥25% of body weight reduction from baseline | Baseline (Week 0) to Week 48 and Week 60 |
| Number of participants with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) | Up to Week 70 |
| Clinical Research Institute of Arizona |
| Recruiting |
| Sun City West |
| Arizona |
| 85375 |
| United States |
| Arizona Clinical Trials (ACT) - Tucson | Recruiting | Tucson | Arizona | 85711 | United States |
| San Fernando Valley Health Institute | Recruiting | Canoga Park | California | 91304 | United States |
| Ark Clinical Research | Recruiting | Fountain Valley | California | 92708 | United States |
| Paragon Rx Clinical | Recruiting | Garden Grove | California | 92840 | United States |
| Torrance Clinical Research Institute, Inc. | Recruiting | Lomita | California | 90717 | United States |
| Ark Clinical Research | Recruiting | Long Beach | California | 90815 | United States |
| Collaborative Neuroscience Research, LLC | Recruiting | Los Alamitos | California | 90720 | United States |
| Paradigm Clinical Research-Modesto | Recruiting | Modesto | California | 95355 | United States |
| Paradigm Clinical Research Centers, LLC | Recruiting | San Diego | California | 92108 | United States |
| University Clinical Investigators, Incorporated | Recruiting | Tustin | California | 92780 | United States |
| Diablo Clinical Research, LLC dba Flourish Research | Recruiting | Walnut Creek | California | 94598 | United States |
| AGA Clinical Trials | Recruiting | Hialeah | Florida | 33012 | United States |
| Westside Center for Clinical Research | Recruiting | Jacksonville | Florida | 32205 | United States |
| New Horizon Research Center | Recruiting | Miami | Florida | 33165 | United States |
| Charter Research | Recruiting | Orlando | Florida | 32803 | United States |
| Atlanta Diabetes Associates | Recruiting | Atlanta | Georgia | 30318 | United States |
| Clinical Research Atlanta | Recruiting | Stockbridge | Georgia | 30281 | United States |
| Koch Family Medicine Clinical Research/Elite Research Network | Recruiting | Morton | Illinois | 61550 | United States |
| Bioluminux Clinical Research Illinois | Recruiting | Naperville | Illinois | 60540 | United States |
| Johnson County Clinical Trials | Recruiting | Lenexa | Kansas | 66219 | United States |
| DelRicht Research | Recruiting | Mandeville | Louisiana | 70471 | United States |
| DelRicht Research | Recruiting | Prairieville | Louisiana | 70769 | United States |
| Patient First Clinical Trials (PFCTRIALS) | Recruiting | Lutherville | Maryland | 21093 | United States |
| DelRicht Research | Recruiting | Springfield | Missouri | 65807 | United States |
| Mercury Street Medical Group, PLLC | Recruiting | Butte | Montana | 59701 | United States |
| Alliance Clinical Research Las Vegas (Excel Clinical Research) | Recruiting | Las Vegas | Nevada | 89109 | United States |
| AB Clinical Trials | Recruiting | Las Vegas | Nevada | 89119 | United States |
| Palm Research Center | Recruiting | Las Vegas | Nevada | 89128 | United States |
| Bioluminux Clinical Research | Recruiting | Hamilton | New Jersey | 08690 | United States |
| DelRicht Research | Recruiting | Charlotte | North Carolina | 28210 | United States |
| Monroe Biomedical Research | Recruiting | Monroe | North Carolina | 28112 | United States |
| Piedmont Healthcare | Recruiting | Statesville | North Carolina | 28625 | United States |
| Accellacare - Wilmington | Recruiting | Wilmington | North Carolina | 28401 | United States |
| Tekton Research, LLC. | Recruiting | Edmond | Oklahoma | 73013 | United States |
| Preferred Primary Care Physicians | Recruiting | Pittsburgh | Pennsylvania | 15236 | United States |
| Preferred Primary Care Physicians, Inc. | Recruiting | Uniontown | Pennsylvania | 15401 | United States |
| Preferred Primary Care Physicians | Recruiting | Uniontown | Pennsylvania | 15401 | United States |
| TMA Headlands LLC (d/b/a Trial Management Associates) | Recruiting | Myrtle Beach | South Carolina | 29572 | United States |
| DelRicht Research | Recruiting | Hendersonville | Tennessee | 37075 | United States |
| Cedar Health Research - Euless | Recruiting | Euless | Texas | 76040 | United States |
| JCCT-JUNO NW Houston | Recruiting | Houston | Texas | 77040 | United States |
| Activian Clinical Research | Recruiting | Kingwood | Texas | 77339 | United States |
| 3A Research | Recruiting | Plano | Texas | 75093 | United States |
| DelRicht Research @ Zomnir Family Medicine | Recruiting | Prosper | Texas | 75078 | United States |
| Worldwide Clinical Trials | Recruiting | San Antonio | Texas | 78217 | United States |
| Tekton Research, LLC. | Recruiting | San Antonio | Texas | 78258 | United States |
| Consano Clinical Research, LLC | Recruiting | Shavano Park | Texas | 78231 | United States |
| DM Clinical Research | Recruiting | Tomball | Texas | 77375 | United States |
| Alpine Medical Group | Recruiting | Salt Lake City | Utah | 84102 | United States |
| Wasatch Clinical Research, LLC | Recruiting | Salt Lake City | Utah | 84107 | United States |
| Washington Center for Weight Management and Research | Recruiting | Arlington | Virginia | 22206 | United States |
| Manassas Clinical Research Center | Recruiting | Manassas | Virginia | 20110 | United States |
| DelRicht Research | Recruiting | Vienna | Virginia | 22182 | United States |
| Viable Clinical Research Corporation | Not yet recruiting | Bridgewater | Nova Scotia | B4V 3N2 | Canada |
| Aggarwal and Associates Limited | Not yet recruiting | Brampton | Ontario | L6T 0G1 | Canada |
| Centricity Research Etobicoke Endocrinology | Not yet recruiting | Etobicoke | Ontario | M9R 4E1 | Canada |
| Milestone Research Inc. | Not yet recruiting | London | Ontario | N5W 6A2 | Canada |
| Bluewater Clinical Research Group Inc. | Not yet recruiting | Sarnia | Ontario | N7T 4X3 | Canada |
| Dr. Anil K. Gupta Medicine Professional Corporation | Recruiting | Toronto | Ontario | M9V 4B4 | Canada |
| Centricity Research Toronto Manna Multispecialty | Not yet recruiting | Toronto | Ontario | M9W 4L6 | Canada |
| Ecogene-21 | Not yet recruiting | Chicoutimi | Quebec | G7H 7K9 | Canada |
| Centricity Research Mirabel Multispecialty | Not yet recruiting | Mirabel | Quebec | J7J 2K8 | Canada |
| Recherche GCP Research | Not yet recruiting | Montreal | Quebec | H1Y 3H5 | Canada |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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