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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-520763-41-00 | Registry Identifier | CTIS (EU) |
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The study was prematurely discontinued due to a business decision. The decision to terminate the study is not related to a safety concern.
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The purpose of this study is to look at safety, tolerability, and pharmacodynamic effects (i.e. how the study drug affects your body) of PF-07258669 in older participants ((60 years to <90 years) including those at risk of malnutrition.
The study medicine PF-07258669 is being developed for the treatment of unintended weight loss in older adults. People with this condition have decreased appetite and food intake, which is an important reason for poor nutrition and health results in people with unintended weight loss.
This is approximately a 26-week-long study with 9 visits to the study doctor and 4 telehealth visits (ie. visits by phone call). The study will include
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| PF-07258669 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Oral tablet |
| |
| PF-07258669 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events | Baseline to Week 20 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change from baseline in body weight | Baseline to Week 16 |
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Inclusion Criteria Are 60 years to <90 years Are males or females who can no longer have children Have Body weight ≥40 kg and Body mass index (BMI) ≤25 kg/m2 Exclusion Criteria Evidence or history of clinically significant medical conditions. Positive for active, untreated HIV, hepatitis B, and/or hepatitis C History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening.
Voluntary diet restriction or eating disorder
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Accel Research Sites - Birmingham Clinical Research Unit | Birmingham | Alabama | 35216 | 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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| Drug |
Oral tablet |
|
| JEM Research Institute |
| Atlantis |
| Florida |
| 33462 |
| United States |
| Bradenton Research Center, Inc. | Bradenton | Florida | 34205 | United States |
| De La Cruz Research Center, LLC | Miami | Florida | 33184 | United States |
| Headlands Research Orlando | Orlando | Florida | 32819 | United States |
| AA Medical Research Center | Flint | Michigan | 48504 | United States |
| Clinical Research Professionals | Chesterfield | Missouri | 63005 | United States |
| Javara - Nevada Health Centers - Carson City | Carson City | Nevada | 89706 | United States |
| Circuit Clinical | Secaucus | New Jersey | 07094 | United States |
| Circuit Clinical /North Hudson Community Action Corporation | West New York | New Jersey | 07093 | United States |
| Alpha Recherche Clinique | Québec | Quebec | G3K 2P8 | Canada |
| Diex Recherche Inc. Division Victoriaville | Victoriaville | Quebec | G6P 3Z8 | Canada |
| Centre de Recherche Saint-Louis inc. | Québec | G1W 4R4 | Canada |
| Yao Tokushukai General Hospital | Yao Shi | Osaka | 581-0011 | Japan |