Clinical trial NCT06991257: A Study to Learn About the Study Medicine Called PF-07328948 in Adults With Heart Failure (BRANCH-HF)
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)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Heart Failure
Keywords: Heart Failure with mildly reduced ejection
Heart Failure with preserved ejection fraction
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2025-05-27
Enrollment: 620
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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 or older.
* - 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%
* Body mass index of 27 kg/m2 or higher
* 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

Primary outcomes:
measure: Number of Participants with Clinical Events
timeFrame: over 36 weeks
measure: Change From Baseline in 6-Minute Walk Test (6MWD)
timeFrame: Baseline, week 36 post-dose
measure: Change From Baseline in Kansas City Cardiomyopathy Questionnaire Overall Total Symptom Score (KCCQ-23 TSS)
timeFrame: Baseline, week 36
Secondary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
timeFrame: Baseline, up to week 40
measure: Change From Baseline in Kansas City Cardiomyopathy Questionnaire Overall Symptom Score (KCCQ-23 TSS) and physical limitation in participants taking PF-07328948 vs. placebo on HF disease-specific health status related to HFmrEF/HFpEF.
timeFrame: Baseline, week 36
measure: Change From Baseline in 6-minute walk test distance (6MWD) in participants taking PF-07328948 vs. placebo on HF disease-specific health status related to HFmrEF/HFpEF.
timeFrame: Baseline, week 36
measure: CPET Substudy) : Change From Baseline in Peak Oxygen Consumption (pVO2) at Week 36
timeFrame: Baseline, Week 36
measure: Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) Concentration at Week 36
timeFrame: Baseline, Week 36
measure: Change From Baseline in Kansas City Cardiomyopathy Questionnaire Overall clinical symptom Score (KCCQ-23 CSS) and physical limitation) in participants taking PF-07328948 vs. placebo on HF disease-specific health status related to HFmrEF/HFpEF.
timeFrame: Baseline, week 36
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: