PF-07328948 for Heart Failure

Recruiting at 4 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?

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).

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