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)
NCT: NCT06991257 ·
Status: RECRUITING ·
Phase: Phase 2
· Sponsor: Pfizer
· Started: 2025-06-19
· Est. Completion: 2027-12-14
Official 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).
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: QUADRUPLE
- Enrollment: 620 participants
Interventions
- DRUG: Placebo — ARM 1
- DRUG: Low Dose PF-07328948 — ARM 2
- DRUG: Medium Dose PF-07328948 — ARM 3
- DRUG: High Dose PF-07328948 — ARM 4
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)
Secondary Outcomes
- Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) (Baseline, up to week 40)
- 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. (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. (Baseline, week 36)
- CPET Substudy) : Change From Baseline in Peak Oxygen Consumption (pVO2) at Week 36 (Baseline, Week 36)
- Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) Concentration at Week 36 (Baseline, Week 36)
Trial Locations
- National Heart Institute, Beverly Hills, California, United States
- Orange County Research Center, Lake Forest, California, United States
- Comprehensive Cardiovascular Care, Santa Maria, California, United States
- FOMAT Medical Research, Santa Maria, California, United States
- FWD Clinical Research, Boca Raton, Florida, United States
- Jacksonville Center for Clinical Research, Jacksonville, Florida, United States
- Infinite Clinical Research, Miami, Florida, United States
- Flourish Research Acquisition, LLC dba Flourish Research - North Miami, Miami, Florida, United States
- Amavita Research Services, North Miami Beach, Florida, United States
- Clinical Site Partners, LLC dba Flourish Research, Winter Park, Florida, United States
- ...and 10 more locations
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AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.