RECRUITING

A Study to Learn About the Study Medicine Called PF-07258669 in Older Adults Including Those at Risk of Malnutrition

Description

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

Study Overview

Study Details

Study overview

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

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

A Study to Learn About the Study Medicine Called PF-07258669 in Older Adults Including Those at Risk of Malnutrition

Condition
Healthy Volunteers
Intervention / Treatment

-

Contacts and Locations

Atlantis

JEM Research Institute, Atlantis, Florida, United States, 33462

Miami

De La Cruz Research Center, LLC, Miami, Florida, United States, 33184

Orlando

Headlands Research Orlando, Orlando, Florida, United States, 32819

Brockton

Shields MRI Brockton, Brockton, Massachusetts, United States, 02301

Plymouth

Headlands Eastern MA LLC, Plymouth, Massachusetts, United States, 02360

Flint

AA Medical Research Center, Flint, Michigan, United States, 48504

Chesterfield

Clinical Research Professionals, Chesterfield, Missouri, United States, 63005

Carson City

Javara - Nevada Health Centers - Carson City, Carson City, Nevada, United States, 89706

Secaucus

Circuit Clinical, Secaucus, New Jersey, United States, 07094

New York

Circuit Clinical /North Hudson Community Action Corporation, New York, New York, United States, 07093

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

    Ages Eligible for Study

    60 Years to 89 Years

    Sexes Eligible for Study

    ALL

    Accepts Healthy Volunteers

    Yes

    Collaborators and Investigators

    Pfizer,

    Pfizer CT.gov Call Center, STUDY_DIRECTOR, Pfizer

    Study Record Dates

    2026-10-25