A Study of Ponsegromab in People With Heart Failure

• Status: Not yet recruiting
• Trial end date: 2024-09-13
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this clinical trial is to compare the effects of study medicine (Ponsegromab/PF-06946860) with a placebo (A pill that looks like the study medicine but does not contain the active medicine) to find out if the study medicine is better than the placebo (a pill that looks like the study medicine but does not contain the active medicine) for treatment of symptoms related to heart failure. Participants will not know which treatment group they are assigned to. All participants in this study will receive the study medicine or placebo by shots under the skin every four weeks. People may be able to participate in this study if they have the heart failure. Participants will take part in this study for about 9 months. During this time participants will visit the study clinic once a month.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Collaborator: Thrombolysis In Myocardial Infarction (TIMI)

Criteria

Inclusion Criteria:

• Male and female participants aged 18 years or older

-. Clinical evidence of HF with each of the following criteria:

1. LVEF <50% on most recent measurement (within the last 12 months).

2. NYHA class II-IV at screening.

3. NT-proBNP ≥400 pg/mL at screening.

• Serum GDF-15 concentration ≥2000 pg/mL at screening.

• KCCQ-23 CSS <75 at screening.

• Evidence of cachexia or fatigue or functional impairment, as demonstrated by at least one of the following:

1. Non-edematous unintentional weight loss ≥5% in the last 6 months or current BMI <20 kg/m2, associated with subjective fatigue or anorexia; or

2. Fatigue at least 3 times per week AND at least moderately bothersome fatigue in the past 2 weeks; or

3. A score of <60 on the Physical Limitations Domain of the KCCQ 23 administered at screening.

Exclusion Criteria:

• Acute decompensated HF within 1 month prior to randomization.

• Implantation of a cardiac resynchronization therapy device or valve repair or replacement within 3 months prior to randomization or intent to do so during the trial.

• History of heart transplantation, currently listed for heart transplant, or planned mechanical circulatory support.

• Acute coronary syndrome within 1 month prior to randomization.

• Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) within 3 months prior to randomization or intent to undergo coronary revascularization during the trial.

• Untreated indication for an implantable cardiac defibrillator or pacemaker to treat a cardiac rhythm abnormality (ie, tachyarrhythmia or bradyarrhythmia).

• Previous administration with an investigational product (drug or vaccine) within 30 days (or as determined by the local requirement) or 5 half lives (whichever is longer) preceding the first dose of study intervention used in this study. Treatment with an investigational biologic agent within 6 months or 5 half-lives (whichever is longer) of Day 1

• Renal disease requiring dialysis.

• Cirrhosis with evidence of portal hypertension not due to HF