Loading clinical trials...
Loading clinical trials...
An Interventional Phase 1b, Randomized, Double-Blind, Sponsor-Open, Placebo-Controlled Study to Investigate the Safety, Tolerability, and Pharmacodynamic Effect of PF-07258669 Compared to Placebo in Older Participants Including Those at Risk of Malnutrition
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 * Screening period for up to 4 weeks * Pre-treatment period of 2 weeks * Treatment period of 16 weeks : study drug (PF-07258669 or matching placebo) * Follow-up period of 4 weeks The study requires answering questionnaires and use of digital devices at home to measure blood pressure and physical activity. The study team will monitor how each participant is doing during the study
Age
60 - 89 years
Sex
ALL
Healthy Volunteers
Yes
Accel Research Sites - Birmingham Clinical Research Unit
Birmingham, Alabama, United States
JEM Research Institute
Atlantis, Florida, United States
Bradenton Research Center, Inc.
Bradenton, Florida, United States
De La Cruz Research Center, LLC
Miami, Florida, United States
Headlands Research Orlando
Orlando, Florida, United States
AA Medical Research Center
Flint, Michigan, United States
Clinical Research Professionals
Chesterfield, Missouri, United States
Javara - Nevada Health Centers - Carson City
Carson City, Nevada, United States
Circuit Clinical
Secaucus, New Jersey, United States
Circuit Clinical /North Hudson Community Action Corporation
West New York, New Jersey, United States
Start Date
August 5, 2025
Primary Completion Date
January 21, 2026
Completion Date
January 21, 2026
Last Updated
February 6, 2026
7
ACTUAL participants
Placebo
DRUG
PF-07258669
DRUG
Lead Sponsor
Pfizer
NCT07310264
NCT06342713
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions