Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

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

This research is testing a new medicine, code-named PF-07258669. It's focused on older adults, particularly those who are at risk of malnutrition – meaning they might not be eating enough or getting all the nutrients they need. This is an early phase of testing, sometimes called a Phase 1 study. The main goal at this stage is to understand how the medicine behaves in the human body. Researchers want to see how it's absorbed, how long it stays in the body, and if it has any early side effects. This type of study is crucial for ensuring new medicines are safe and to figure out the right dosage for future research.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Pfizer Inc.

Enrolment target

Start

19 Nov 2025

Older adults at risk of malnutrition

What is this study about?

This study is about a new medicine, currently known as PF-07258669. It's designed specifically for older adults, especially those who might be struggling to get enough food or the right nutrients. This can be a common problem as people get older, and it can affect their health in many ways.

The main purpose of this study is to learn how this new medicine works inside the human body. This is an early-stage study, often called a 'Phase 1' study. At this point, scientists aren't looking to see if the medicine can treat a specific illness. Instead, they want to understand fundamental things like how the medicine is absorbed, how it's processed, and how quickly it leaves the body. They also want to check for early signs of safety and help decide on the best dosage for the future.

By taking part, you would be helping researchers gather important information that is essential before the medicine can move on to larger studies. This step is vital for developing new, safe, and effective treatments that could potentially help older adults maintain their health and well-being.

Key takeaways

Tests a new medicine (PF-07258669) in older adults.
Focuses on those at risk of malnutrition.
Early-stage study (Phase 1) looking at how the medicine works and its safety.
Both men and women can take part.
Participation involves clinic visits and close monitoring.
You can withdraw at any time.

Who may be eligible?

This study is looking for older adults to take part. There isn't a specific age given, so they're open to people of various ages who are considered 'older adults'.

They are particularly interested in people who might be at risk of malnutrition. This could mean you've been losing weight without trying, or perhaps you're finding it hard to eat enough nourishing food.

Both men and women can take part in this study. The medical team will review your health information to make sure the study is a good fit for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you an older adult?
Are you concerned you might not be getting enough nutrients?
Are you available for regular clinic visits?
Are you willing to take a new study medicine?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the new study medicine, PF-07258669. This isn't a long-term commitment, as it's an early-stage study. You would likely have regular visits to the clinic, which might involve checks like blood tests, measuring your vital signs (like blood pressure and heart rate), and filling out questionnaires. The medical team will closely monitor your health throughout the study to make sure you are safe and well. The total length of your participation is expected to be relatively short, but the exact number of visits and the overall duration will be fully explained to you before you agree to join.

Potential risks and benefits

Taking part in a study like this could mean you are among the first to receive this new medicine, which might offer some potential benefit, though this is not the main goal at this early stage. However, as with any new medicine, there could be risks of side effects. These could be mild, like a headache, or more serious, though researchers will be very careful to monitor your health. You will be told all known risks before you make a decision, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain

Common questions

What is malnutrition?

Malnutrition means your body isn't getting enough nutrients to stay healthy. This can happen if you don't eat enough, or if what you eat isn't giving you the right vitamins and minerals.

What is a 'Phase 1' study?

Phase 1 studies are the first step in testing a new medicine in people. They focus on understanding how the medicine works in the body and checking for early safety signs, rather than seeing if it can cure a disease.

Will I or someone I know get better if we take part?

While it's possible, the main aim of this early study is not to treat a condition but to gather information on the new medicine's safety and how it works in the body. Benefits for patients are usually explored in later studies.

Will I have to stay in hospital?

Some early-stage studies might involve short stays in a clinic or hospital for close monitoring, but it's not always the case. The research team will explain exactly what's involved if you are eligible.

Who is funding this research?

This study is being sponsored by Pfizer, the company that developed the medicine PF-07258669. This information will be clearly stated if you are considering joining the study.