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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07086664

Enrollment

Registered

2025-07-25

Start date

2025-08-05

Completion date

2026-01-21

Last updated

2026-02-06

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

Conditions

Healthy Volunteers

Keywords

Malnutrition risk

Brief 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

Interventions

DRUGPlacebo

Oral tablet

DRUGPF-07258669

Oral tablet

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

60 Years to 89 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Number of Participants With Treatment Emergent Adverse Events	Baseline to Week 20

Secondary

Measure	Time frame
Percent change from baseline in body weight	Baseline to Week 16

Countries

Canada, Japan, United States

Contacts

STUDY_DIRECTORPfizer CT.gov Call Center

Pfizer

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026