A Study to Learn About the Study Medicine Called PF-07328948 in Adults With Heart Failure (BRANCH-HF)

NCT06991257 · Pfizer

Recruiting

In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

Official title

A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF AN ORAL BRANCHED-CHAIN KETOACID DEHYDROGENASE KINASE INHIBITOR, PF-07328948, IN ADULTS WITH HEART FAILURE (BRANCH-HF)

About this study

All participants in this study will take either the study medicine (PF-07328948) tablets, or placebo tablets, once daily, by mouth, every day for 36 weeks. 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-of-care medications for heart failure that include sodium-glucose cotransporter 2 (SGLT2) inhibitors. Participants will be involved in this study for about 48 weeks. During this time, participants will visit the study clinic 15 times. In general, 5 of these visits may be performed at home by phone and the other 10 visits will take place at the study site.

Eligibility criteria

This study is seeking participants who are: Key Inclusion Criteria include: * aged 18 years to \< 80 years * clinically confirmed to have a diagnosis of heart failure for at least 3 months * New York Heart Association Class II-IV symptoms * left ventricular ejection fraction greater than 40% * Kansas City Cardiomyopathy Questionnaire-23 Total Symptom Score \< 85 * Six-minute walking distance greater than 75 meters Key Exclusion Criteria include: * Type 1 diabetes mellitus, liver cirrhosis or any condition that can possibly affect how the medicine is absorbed into the body. * Major surgery scheduled for the duration of the study, affecting walking ability in the opinion of the study doctor. * History of heart transplantation, or currently listed for a heart transplant, or current planned use of IV vasodilators and/ or inotropes * Prior intolerance/known hypersensitivity to an SGLT2 inhibitor or contraindication to an SGLT2 inhibitor

Study design

Enrollment target: 620 participants

Allocation: randomized

Masking: quadruple

Age groups: adult, older_adult

Timeline

Starts: 2025-06-19

Estimated completion: 2027-12-14

Last updated: 2026-04-14

Interventions

Drug: PlaceboDrug: Low Dose PF-07328948Drug: Medium Dose PF-07328948Drug: High Dose PF-07328948

Primary outcomes

• Number of Participants with Clinical Events (over 36 weeks)
• Change From Baseline in 6-Minute Walk Test (6MWD) (Baseline, week 36 post-dose)
• Change From Baseline in Kansas City Cardiomyopathy Questionnaire Overall Total Symptom Score (KCCQ-23 TSS) (Baseline, week 36)

Sponsor

Pfizer · industry

Contacts & investigators

ContactPfizer CT.gov Call Center · contact · ClinicalTrials.gov_Inquiries@pfizer.com · 1-800-718-1021

InvestigatorPfizer CT.gov Call Center · study_director, Pfizer

All locations (132)

National Heart InstituteRecruiting

Beverly Hills, California, United States

Orange County Research CenterRecruiting

Lake Forest, California, United States

Comprehensive Cardiovascular CareRecruiting

Santa Maria, California, United States

FOMAT Medical ResearchRecruiting

Santa Maria, California, United States

FWD Clinical ResearchRecruiting

Boca Raton, Florida, United States

Jacksonville Center for Clinical ResearchNot Yet Recruiting

Jacksonville, Florida, United States

Infinite Clinical ResearchRecruiting

Miami, Florida, United States

Flourish Research Acquisition, LLC dba Flourish Research - North MiamiRecruiting

Miami, Florida, United States

Amavita Research ServicesRecruiting

North Miami Beach, Florida, United States

Clinical Site Partners, LLC dba Flourish ResearchRecruiting

Winter Park, Florida, United States

NMH Clinical Research UnitNot Yet Recruiting