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

Pfizer

Status and phase

Not yet enrolling

Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: PF-07258669

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT07086664

2025-520763-41-00 (Registry Identifier)

C4541011

Details and patient eligibility

About

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

Enrollment

60 estimated patients

Sex

All

Ages

60 to 90 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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