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)
Pfizer
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).
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…
Eligibility
- Age range
- 18–79 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugPlacebo
ARM 1
- DrugLow Dose PF-07328948
ARM 2
- DrugMedium Dose PF-07328948
ARM 3
- DrugHigh Dose PF-07328948
ARM 4
Locations (135)
- National Heart InstituteBeverly Hills, California
- Orange County Research CenterLake Forest, California
- Comprehensive Cardiovascular CareSanta Maria, California
- FOMAT Medical ResearchSanta Maria, California
- FWD Clinical ResearchBoca Raton, Florida
- Jacksonville Center for Clinical ResearchJacksonville, Florida