Healthy VolunteersPhase 1NCT07086664
A Study to Learn About the Study Medicine Called PF-07258669 in Older Adults Including Those at Risk of Malnutrition
A Phase 1 study testing PF-07258669 in people with Healthy Volunteers, run by Pfizer at 14 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- PF-07258669
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 14 sitesin 3 countries
- Study dates
- 5 Aug 2025to 21 Jan 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Trial locations and contacts
14 sites in 3 countries.
14 sites in 3 countries
United States10 sites
JEM Research Institute
Atlantis, Florida, 33462
Accel Research Sites - Birmingham Clinical Research Unit
Birmingham, Alabama, 35216
Bradenton Research Center, Inc.
Bradenton, Florida, 34205
Javara - Nevada Health Centers - Carson City
Carson City, Nevada, 89706
Clinical Research Professionals
Chesterfield, Missouri, 63005
AA Medical Research Center
Flint, Michigan, 48504
De La Cruz Research Center, LLC
Miami, Florida, 33184
Headlands Research Orlando
Orlando, Florida, 32819
Circuit Clinical
Secaucus, New Jersey, 07094
Circuit Clinical /North Hudson Community Action Corporation
West New York, New Jersey, 07093
Canada3 sites
Alpha Recherche Clinique
Québec, Quebec, G3K 2P8
Centre de Recherche Saint-Louis inc.
Québec, G1W 4R4
Diex Recherche Inc. Division Victoriaville
Victoriaville, Quebec, G6P 3Z8
About this study
Official title: 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
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.
Read more
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
- Being tested
- Placebo, PF-07258669
- Keywords
- Malnutrition risk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Oral tablet
PF-07258669Drug
Oral tablet
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| PF-07258669 | Experimental | Not described Receives: Drug: PF-07258669 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment Emergent Adverse Events
Measured: Baseline to Week 20
Secondary outcomes (1)
Percent change from baseline in body weight
Measured: Baseline to Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start5 Aug 2025
- Primary completion21 Jan 2026
- Study completion21 Jan 2026
Why it stopped: The study was prematurely discontinued due to a business decision. The decision to terminate the study is not related to a safety concern.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07086664
- Sponsor's protocol ID
- C4541011
- Other IDs
- 2025-520763-41-00, 2025
- Status last verified
- Feb 2026
- First submitted
- 18 Jul 2025
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07086664
- Acronym / sponsor ID
- C4541011
- Conditions
- Healthy Volunteers
- Keywords
- Malnutrition risk
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was prematurely discontinued due to a business decision. The decision to terminate the study is not related to a safety concern.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 5 Aug 2025 (actual)
- Primary completion
- 21 Jan 2026 (actual)
- Study completion
- 21 Jan 2026 (actual)
- First posted
- 25 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| PF-07258669 | Experimental | Drug: PF-07258669 |
Who may qualify
- Ages
- 60 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboOral tablet | Drug | Placebo |
| PF-07258669Oral tablet | Drug | PF-07258669 |
Primary outcome
Number of Participants With Treatment Emergent Adverse Events
Time frame: Baseline to Week 20
1 secondary outcome
Percent change from baseline in body weight
Time frame: Baseline to Week 16
Results and safety
The study was stopped early (reason given: The study was prematurely discontinued due to a business decision. The decision to terminate the study is not related to a safety concern.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
14 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PF-07258669 in people with Healthy Volunteers, run by Pfizer at 14 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Canada, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study was prematurely discontinued due to a business decision. The decision to terminate the study is not related to a safety concern.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment Emergent Adverse Events (time frame: Baseline to Week 20). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026; AzTrials last refreshed its copy on 30 Oct 2026.