NCT06991257|RecruitingPhase 2DMCFDA Drug

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)

Pfizer ClinicalTrials.gov

Compare

2 other identifiers

C49210032024-518438-94-00

Study Type

interventional

Target

620

Locations

13 countries

Sites

141

Timeline

RegisteredMay 2025

StartedJun 2025

CompletionDec 2027

Brief 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).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

620

participants targeted

Target at P75+ for phase_2 heart-failure

Timeline

19mo left

Started Jun 2025

Typical duration for phase_2 heart-failure

Geographic Reach

13 countries

141 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.5 years study duration

Study Progress37%

Jun 2025Dec 2027

First Submitted

Initial submission to the registry

May 19, 2025

Completed

8 days until next milestone

First Posted

Study publicly available on registry

May 27, 2025

Completed

23 days until next milestone

Study Start

First participant enrolled

June 19, 2025

Completed

2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 16, 2027

Expected

28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2027

Last Updated

May 19, 2026

Status Verified

May 1, 2026

Enrollment Period

2.4 years

First QC Date

May 19, 2025

Last Update Submit

May 18, 2026

Conditions

Heart Failure

Keywords

Heart Failure with mildly reduced ejectionHeart Failure with preserved ejection fraction

Outcome Measures

Primary Outcomes (3)

Number of Participants with Clinical Events
Adjudicated cardiovascular death and worsening heart failure events through 36 weeks.
over 36 weeks
Change From Baseline in 6-Minute Walk Test (6MWD)
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.
Baseline, week 36 post-dose
Change From Baseline in Kansas City Cardiomyopathy Questionnaire Overall Total Symptom Score (KCCQ-23 TSS)
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.
Baseline, week 36

Secondary Outcomes (6)

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
+1 more secondary outcomes

Study Arms (4)

ARM 1

PLACEBO COMPARATOR

Placebo Participants will receive Placebo for up to 36 weeks

Drug: Placebo

ARM 2

EXPERIMENTAL

Low dose PF-07328948 Participants will receive PF-07328948 for up to 36 weeks

Drug: Low Dose PF-07328948

ARM 3

EXPERIMENTAL

Medium dose PF-07328948 Participants will receive PF-07328948 for up to 36 weeks

Drug: Medium Dose PF-07328948

ARM 4

EXPERIMENTAL

High dose PF-07328948 Participants will receive PF-07328948 for up to 36 weeks

Drug: High Dose PF-07328948

Interventions

PlaceboDRUG

ARM 1

Low Dose PF-07328948DRUG

ARM 2

Also known as: low dose

ARM 2

Medium Dose PF-07328948DRUG

ARM 3

Also known as: medium dose

ARM 3

High Dose PF-07328948DRUG

ARM 4

Also known as: High dose

ARM 4

Eligibility Criteria

Age18 Years - 79 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Pfizerlead

Study Sites (141)

National Heart Institute

Beverly Hills, California, 90211, United States

RECRUITING

Orange County Research Center

Lake Forest, California, 92630, United States

RECRUITING

Comprehensive Cardiovascular Care

Santa Maria, California, 93454, United States

RECRUITING

FOMAT Medical Research

Santa Maria, California, 93454, United States

RECRUITING

FWD Clinical Research

Boca Raton, Florida, 33486, United States

ACTIVE NOT RECRUITING

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

RECRUITING

Infinite Clinical Research

Miami, Florida, 33133, United States

RECRUITING

Flourish Research Acquisition, LLC dba Flourish Research - North Miami

Miami, Florida, 33138, United States

RECRUITING

Amavita Research Services

North Miami Beach, Florida, 33169, United States

RECRUITING

Clinical Site Partners, LLC dba Flourish Research

Winter Park, Florida, 32789, United States

RECRUITING

NMH Clinical Research Unit