A Phase 1 interventional study of Placebo and PF-07258669 in Healthy Volunteers, sponsored by Pfizer. Terminated at 14 sites in 3 countries. Open to participants aged 60 Years to 89 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-06.
Sponsored by Pfizer · Phase 1, Interventional, and Basic science
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
Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
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
Drug: Placebo
Drug: PF-07258669
Oral tablet
Oral tablet
Number of Participants With Treatment Emergent Adverse Events
Time frame: Baseline to Week 20
Percent change from baseline in body weight
Time frame: Baseline to Week 16
Plan to share: No — 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.
This study is terminated, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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