ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

Official Title

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

Quick Facts

Study Start:2025-08-05
Study Completion:2026-01-21
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT07086664

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.

Ages Eligible for Study:60 Years to 89 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Pfizer CT.gov Call Center
STUDY_DIRECTOR
Pfizer

Study Locations (Sites)

Accel Research Sites - Birmingham Clinical Research Unit
Birmingham, Alabama, 35216
United States
JEM Research Institute
Atlantis, Florida, 33462
United States
Bradenton Research Center, Inc.
Bradenton, Florida, 34205
United States
McKnight Brain Institute
Gainesville, Florida, 32610
United States
De La Cruz Research Center, LLC
Miami, Florida, 33184
United States
Renstar Medical Research
Ocala, Florida, 34471
United States
Headlands Research Orlando
Orlando, Florida, 32819
United States
Shields MRI Brockton
Brockton, Massachusetts, 02301
United States
Headlands Eastern MA LLC
Plymouth, Massachusetts, 02360
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

Collaborators and Investigators

Sponsor: Pfizer

  • Pfizer CT.gov Call Center, STUDY_DIRECTOR, Pfizer

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-05
Study Completion Date2026-01-21

Study Record Updates

Study Start Date2025-08-05
Study Completion Date2026-01-21

Terms related to this study

Keywords Provided by Researchers

  • Malnutrition risk

Additional Relevant MeSH Terms

  • Healthy Volunteers