Trials / Recruiting
RecruitingNCT06991257
A Study to Learn About the Study Medicine Called 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)
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 620 (estimated)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 18 Years – 79 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2025-06-19
- Primary completion
- 2027-11-16
- Completion
- 2027-12-14
- First posted
- 2025-05-27
- Last updated
- 2026-04-14
Locations
132 sites across 13 countries: United States, Brazil, Bulgaria, Canada, China, Czechia, France, Hungary, Japan, Poland, Puerto Rico, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06991257. Inclusion in this directory is not an endorsement.