NCT07086664

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

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 60 Years – 89 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Placebo	Oral tablet
DRUG	PF-07258669	Oral tablet

Timeline

• Start date: 2025-08-05
• Primary completion: 2026-01-21
• Completion: 2026-01-21
• First posted: 2025-07-25
• Last updated: 2026-02-06

Locations

14 sites across 3 countries: United States, Canada, Japan

Regulatory

• FDA-regulated drug study