PF-07328948 for Heart Failure

Recruiting at 25 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Pfizer

Must not be taking: SGLT2 inhibitors

Disqualifiers: Type 1 diabetes, Liver cirrhosis, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 10

Duration: 36 weeks

620 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the safety and effects of a new medicine, PF-07328948, for treating heart failure. Participants will receive a low, medium, or high dose of the medicine, or a placebo (a harmless pill with no active ingredients) for up to 36 weeks. The trial aims to assess the medicine's effectiveness and safety for individuals with heart failure. It is suitable for those who have experienced heart failure for at least three months and struggle with daily activities due to their symptoms. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.

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 this trial's treatments are likely to be safe?

Research has shown that PF-07328948 is still undergoing safety testing in humans. Early results from a study on single doses of PF-07328948 indicate that researchers are carefully examining how people handle the treatment, including the drug's movement through the body and its effects. As this trial is in an early stage, the main goal is to gather information on the safety of PF-07328948 for people with heart failure. Although detailed safety information is limited, early studies ensure that participants are closely monitored for any side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for heart failure?

Researchers are excited about PF-07328948 for heart failure because it offers a potentially groundbreaking approach compared to current treatments like ACE inhibitors, beta-blockers, and diuretics. Unlike these standard options that mainly manage symptoms or reduce workload on the heart, PF-07328948 may target underlying mechanisms of heart failure directly. This investigational drug is being tested in low, medium, and high doses, which could provide flexibility in tailoring treatment to patient needs. Its novel mechanism and potential for more personalized dosing make PF-07328948 an exciting development in heart failure therapy.

What evidence suggests that PF-07328948 might be an effective treatment for heart failure?

Research has shown that PF-07328948 targets an enzyme called BCKDK, potentially offering a new way to treat heart failure. Early studies suggest this treatment could improve heart function and enhance patient well-being. Although still under investigation, its unique approach offers hope for better heart failure management. The trial will evaluate different doses of PF-07328948 to assess their safety and effectiveness. This innovative treatment is part of ongoing efforts to find better solutions for people with heart failure. ^{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?

Adults aged 18 or older with heart failure for at least 3 months, showing specific symptoms and physical capabilities. They must have a certain heart function level, body mass index, symptom severity score, and be able to walk more than 75 meters in six minutes.

Inclusion Criteria

Body mass index of 27 kg/m2 or higher

Kansas City Cardiomyopathy Questionnaire-23 Total Symptom Score < 85

I am 18 years old or older.

Exclusion Criteria

I have major surgery planned that will affect my ability to walk.

I have had a heart transplant, am waiting for one, or will use specific heart medications.

I am allergic or have had a bad reaction to SGLT2 inhibitors.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either PF-07328948 or placebo tablets once daily for 36 weeks

36 weeks

10 visits (in-person), 5 visits (phone)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• PF-07328948

Trial Overview The trial is testing the safety and effects of PF-07328948 on heart failure. Participants will receive either a high, medium, or low dose of the medication or a placebo to compare outcomes.

How Is the Trial Designed?

Group I: ARM 4 Experimental Treatment 1 Intervention

High dose PF-07328948 Participants will receive PF-07328948 for up to 36 weeks

Group II: ARM 3 Experimental Treatment 1 Intervention

Medium dose PF-07328948 Participants will receive PF-07328948 for up to 36 weeks

Group III: ARM 2 Experimental Treatment 1 Intervention

Low dose PF-07328948 Participants will receive PF-07328948 for up to 36 weeks

Group IV: ARM 1 Placebo Group 1 Intervention

Placebo Participants will receive Placebo for up to 36 weeks

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/NCT06991257

NCT06991257 | A Study to Learn About the ... The study determines if the study medicine (PF-07328948) is safe and effective compared to placebo in people with heart failure who are already taking standard- ...

2. pfizerclinicaltrials.com pfizerclinicaltrials.com/find-a-trial/nct06991257-heart-failure-trial

Clinical Trial for Heart Failure. | Pfizer The purpose of this study is to learn about the safety and effects of the study medicine (PF-07328948) for the possible treatment of heart failure (HF).

3. synapse.patsnap.com synapse.patsnap.com/blog/pf-07328948-a-potential-breakthrough-in-treating-heart-failure-with-normal-ejection-fraction

PF-07328948: A Potential Breakthrough in Treating Heart ... PF-07328948's target of BCKDK suggests a potential new approach to treating heart failure and may offer a novel therapeutic avenue within the ...

4. ctv.veeva.com ctv.veeva.com/study/a-first-in-human-study-of-single-doses-of-pf-07328948-which-is-given-to-healthy-adult-participants

A First-in-human Study of Single Doses of PF-07328948 ... This study is the first clinical study with PF-07328948. The safety, tolerability, and plasma pharmacokinetics and pharmacodynamics of PF-07328948

5. theglobeandmail.com theglobeandmail.com/investing/markets/stocks/PFE/pressreleases/35739046/pfizers-promising-heart-failure-study-a-potential-game-changer/

Pfizer's Promising Heart Failure Study: A Potential Game- ... It is designed to treat heart failure by improving heart function and patient outcomes. The study includes different doses of PF-07328948 and a ...

6. withpower.com withpower.com/trial/phase-2-heart-failure-5-2025-dcf71

PF-07328948 for Heart Failure The purpose of this study is to learn about the safety and effects of the study medicine (PF-07328948) for the possible treatment of heart failure (HF). Show ...

7. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/81/NCT05654181/Prot_000.pdf

PF-07328948 Protocol C4921001 Final ... The purpose of the study is to evaluate the safety, tolerability, plasma PK and PD of PF-07328948 following administration of escalating, single ...