NCT07086664

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

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_1 healthy-volunteers

Timeline
Completed

Started Aug 2025

Typical duration for phase_1 healthy-volunteers

Geographic Reach
3 countries

14 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 25, 2025

Completed
11 days until next milestone

Study Start

First participant enrolled

August 5, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 21, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2026

Completed
Last Updated

February 6, 2026

Status Verified

February 1, 2026

Enrollment Period

6 months

First QC Date

July 18, 2025

Last Update Submit

February 4, 2026

Conditions

Healthy Volunteers

Keywords

Malnutrition risk

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Treatment Emergent Adverse Events

    Baseline to Week 20

Secondary Outcomes (1)

  • Percent change from baseline in body weight

    Baseline to Week 16

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

PF-07258669

EXPERIMENTAL
Drug: PF-07258669

Interventions

PlaceboDRUG

Oral tablet

Placebo
PF-07258669DRUG

Oral tablet

PF-07258669

Eligibility Criteria

Age60 Years - 89 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Voluntary diet restriction or eating disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Accel Research Sites - Birmingham Clinical Research Unit

Birmingham, Alabama, 35216, United States

Location

JEM Research Institute

Atlantis, Florida, 33462, United States

Location

Bradenton Research Center, Inc.

Bradenton, Florida, 34205, United States

Location

De La Cruz Research Center, LLC

Miami, Florida, 33184, United States

Location

Headlands Research Orlando

Orlando, Florida, 32819, United States

Location

AA Medical Research Center

Flint, Michigan, 48504, United States

Location

Clinical Research Professionals

Chesterfield, Missouri, 63005, United States

Location

Javara - Nevada Health Centers - Carson City

Carson City, Nevada, 89706, United States

Location

Circuit Clinical

Secaucus, New Jersey, 07094, United States

Location

Circuit Clinical /North Hudson Community Action Corporation

West New York, New Jersey, 07093, United States

Location

Alpha Recherche Clinique

Québec, Quebec, G3K 2P8, Canada

Location

Diex Recherche Inc. Division Victoriaville

Victoriaville, Quebec, G6P 3Z8, Canada

Location

Centre de Recherche Saint-Louis inc.

Québec, G1W 4R4, Canada

Location

Yao Tokushukai General Hospital

Yao Shi, Osaka, 581-0011, Japan

Location

Related Links

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2025

First Posted

July 25, 2025

Study Start

August 5, 2025

Primary Completion

January 21, 2026

Study Completion

January 21, 2026

Last Updated

February 6, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Locations

CA(3)US(10)JP(1)