臨床研究等提出・公開システム

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) (BRANCH-HF)

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

Kawai Norisuke

Pfizer R&D Japan G.K.

Shinjuku Bunka Quint Bldg., 3-22-7 Yoyogi, Shibuya-ku, Tokyo

clinical-trials@pfizer.com

Clinical Trials Information Desk

Pfizer R&D Japan G.K.

Shinjuku Bunka Quint Bldg., 3-22-7 Yoyogi, Shibuya-ku, Tokyo

+81-3-5309-7000

clinical-trials@pfizer.com

Recruiting

Aug. 27, 2025

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

*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
*Walking distance of 75 meters or more in six-minute walking test

*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

Both

Heart failure with mildly reduced or preserved ejection fraction

*Drug: Placebo
-ARM 1
*Drug: Low Dose PF-07328948
-ARM 2
-Other Names:
#low dose
*Drug: Medium Dose PF-07328948
-ARM 3
-Other Names:
#medium dose
*Drug: High Dose PF-07328948
-ARM 4
-Other Names:
#High dose

*Number of Participants with Clinical Events [Time Frame: over 36 weeks]
-Adjudicated cardiovascular death and worsening heart failure events through 36 weeks.
*Change From Baseline in 6-Minute Walk Test (6MWD) [Time Frame: Baseline, week 36 post-dose]
-A submaximal exercise test that measures the distance the participant can walk within prescribed time of 6 minutes. Participants are asked to perform the test at a pace comfortable to them with as many breaks as needed. The total distance walked is recorded.
*Change From Baseline in Kansas City Cardiomyopathy Questionnaire Overall Total Symptom Score (KCCQ-23 TSS) [Time Frame: Baseline, week 36]
-KCCQ is a 23-item heart-failure specific questionnaire quantified into the following scores: symptom frequency, symptom burden, symptom stability, physical limitations, social limitations, quality of life, and self-efficacy, total symptom score, overall summary score, and clinical summary score. To facilitate interpretation, all scores are presented on a scale of 0 to 100 points, with lower scores indicating more severe symptoms and/or limitations, and a score of 100 indicating no symptoms, no limitations, and excellent quality of life.

*Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) [Time Frame: Baseline, up to week 40]
*Change From Baseline in Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-23 TSS), Clinical Summary Score (CSS) and physical limitation in participants taking PF-07328948 vs. placebo on HF disease-specific health status related to HFmrEF/HFpEF. [Time Frame: Baseline, week 36]
*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. [Time Frame: Baseline, week 36]
*CPET Substudy : Change From Baseline in Peak Oxygen Consumption (pVO2) at Week 36 [Time Frame: Baseline, Week 36]
*Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) Concentration at Week 36 [Time Frame: Baseline, Week 36]

+81-3-6665-0572

June. 12, 2025

Yes

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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