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

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031250300

Enrollment

Registered

2025-08-19

Start date

2025-09-24

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Older Adults Including Those at Risk of Malnutrition

Interventions

*Drug: Placebo -Oral tablet *Drug: PF-07258669 -Oral tablet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Are 60 years to =40 kg and Body mass index (BMI) <=25 kg/m2

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
*Number of Participants With Treatment Emergent Adverse Events [Time Frame: Baseline to Week 20]	—

Secondary

Measure	Time frame
*Percent change from baseline in body weight [Time Frame: Baseline to Week 16]	—

Countries

Canada, Japan, United States

Contacts

Public ContactClinical Trials Information Desk

Pfizer R&D Japan G.K.

clinical-trials@pfizer.com+81-3-5309-7000

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026