PF-07258669 for Healthy Older Adults

Recruiting at 11 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Pfizer

Disqualifiers: HIV, Hepatitis B/C, Alcohol abuse, others

Compensation: Varies

Number of Visits: 11

Duration: 16 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new medicine, PF-07258669, to determine its safety and effectiveness for older adults experiencing unintentional weight loss. Such weight loss can occur when individuals eat less due to reduced hunger, potentially leading to poor health. The study compares the effects of the new medicine against a placebo (a pill with no active medicine) to assess improvements in appetite and nutrition. Suitable candidates for this trial are those aged 60 to under 90, experiencing unintended weight loss, and with a BMI of 25 or lower. Participants will visit the study doctor and have phone check-ins over approximately 26 weeks to monitor progress. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that PF-07258669 is likely to be safe for humans?

In earlier studies, researchers tested PF-07258669 on healthy adults to assess its safety and tolerability. Research shows that participants generally tolerated the treatment well. Some mild side effects occurred, but they were not serious. The studies primarily examined the drug's behavior in the body to understand its safety profile. As this trial is in an early stage, it aims to gather more safety information for older adults who might benefit from the treatment.

The main goal of this type of study is to ensure the treatment's safety and understand its effects on the body. So far, results have been promising, but the ongoing study will provide more detailed safety information. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for unintended weight loss?

PF-07258669 is unique because it targets specific age-related pathways that are not addressed by existing treatments. Unlike current options that mainly focus on symptomatic relief, this drug aims to tackle underlying biological processes associated with aging. Researchers are excited about PF-07258669 because it could potentially slow down or modify the aging process itself, offering a novel approach to enhancing the health span of older adults. This mechanism could lead to better outcomes and improved quality of life compared to standard treatments.

What evidence suggests that PF-07258669 might be an effective treatment for unintended weight loss in older adults?

Research shows that PF-07258669 is being developed to treat unplanned weight loss in older adults, a condition often involving reduced food intake and poor nutrition. In this trial, participants will receive either PF-07258669 or a placebo. Although detailed results from human studies remain limited, the drug aims to boost appetite and increase food intake. Early studies focus on safety and the body's response to the drug. The goal is for PF-07258669 to improve nutrition and health for those facing this challenging condition. ^{1 2 3 6 7}

Who Is on the Research Team?

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

This trial is for older adults aged 60 to less than 90, including those at risk of malnutrition. It's designed to study the effects of PF-07258669 on unintended weight loss. Participants will be involved in a 26-week study with visits and telehealth check-ins.

Inclusion Criteria

I am between 60 and 90 years old.

Males or females who can no longer have children

Body mass index (BMI) ≤25 kg/m2

Exclusion Criteria

I have a history of serious health issues.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

up to 4 weeks

1 visit (in-person)

Pre-treatment

Participants undergo a pre-treatment period to prepare for the study drug administration

2 weeks

1 visit (in-person)

Treatment

Participants receive the study drug (PF-07258669 or matching placebo) for 16 weeks

16 weeks

8 visits (in-person), 4 visits (telehealth)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• PF-07258669

Trial Overview PF-07258669, a potential treatment for unintentional weight loss in the elderly, is being tested against a placebo. The trial includes screening, pre-treatment, treatment with either the drug or placebo, and follow-up periods.

How Is the Trial Designed?

Group I: PF-07258669 Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07086664

NCT07086664 | A Study to Learn About the ... The study medicine PF-07258669 is being developed for the treatment of unintended weight loss in older adults. People with this condition have decreased ...

2. pfizerclinicaltrials.com pfizerclinicaltrials.com/find-a-trial/nct07086664-healthy-volunteers-trial

Clinical Trial Seeking Healthy Volunteers | Pfizer The study medicine PF-07258669 is being developed for the treatment of unintended weight loss in older adults. People with this condition have decreased ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06706869

NCT06706869 | A Study to Learn if the ... The study medicine PF-07258669 is developed for the treatment of unintended weight loss in older adults. People with this condition have decreased appetite and ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05113940

A Study of PF-07258669 In Healthy Adult Participants Part A of this study is to evaluate safety, tolerability, and pharmacokinetics (PK) of PF-07258669 after administration of multiple ascending oral doses to ...

5. tipranks.com tipranks.com/news/company-announcements/pfizers-new-study-on-pf-07258669-a-potential-game-changer-for-elderly-nutrition

Pfizer's New Study on PF-07258669: A Potential Game- ... The study aims to assess the safety and effects of PF-07258669, a drug developed to treat unintended weight loss in older adults, a condition ...

6. ctv.veeva.com ctv.veeva.com/study/a-study-of-pf-07258669-in-healthy-adult-participants

A Study of PF-07258669 In Healthy Adult Participants This study is to evaluate safety, tolerability, and pharmacokinetics (PK) of PF-07258669 after administration of multiple ascending oral doses to healthy adult ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05113940

A Study of PF-07258669 In Healthy Adult Participants Part A of this study is to evaluate safety, tolerability, and pharmacokinetics (PK) of PF-07258669 after administration of multiple ascending oral doses to ...