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)
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)
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).
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.
This study is seeking participants who are:
Key Inclusion Criteria include:
Key Exclusion Criteria include:
ClinicalTrials.gov_Inquiries@pfizer.com1-800-718-1021
Miami, Florida 33138, United States
Winter Park, Florida 32789, United States
Chicago, Illinois 60611, United States
Chicago, Illinois 60611, United States
Lincoln, Nebraska 68510, United States
Brownsville, Texas 78526, United States
Belo Horizonte, Minas Gerais 30150-274, Brazil
Porto Alegre, Rio Grande do Sul 90430-001, Brazil
Ribeirão Preto, São Paulo 14026-900, Brazil
São José do Rio Preto, São Paulo 15090000, Brazil
Botucatu, SÃO PAUL 18618-970, Brazil
Sofia, Sofia (stolitsa) 1233, Bulgaria
Sofia, Sofia (stolitsa) 1431, Bulgaria
Plovdiv, 4002, Bulgaria
Shebrooke, Quebec J1E 0N8, Canada
Terrebonne, Quebec J6V 2H2, Canada
Saint-Herblain, Loire-atlantique 44800, France
Toulon, Provence-Alpes-Côte d'Azur Region 83100, France
Itabashi-ku, Tokyo 173-0015, Japan
Kodaira-shi, Tokyo 187-8510, Japan
Meguro-Ku, Tokyo 152-8902, Japan
Suginami, Tokyo 168-0065, Japan
Toshimaku, Tokyo 171-0014, Japan
Poznan, Greater Poland Voivodeship 61-848, Poland
Torun, Kuyavian-Pomeranian Voivodeship 87-100, Poland
Sopot, Pomeranian Voivodeship 81-717, Poland
Santiago de Compostela, A Coruña [LA Coruña] 15706, Spain
L'Hospitalet de Llobregat, Catalunya [cataluña] 08907, Spain
Norwich, Norfolk NR4 7UY, United Kingdom