Investigational Weight Loss and HFpEF Treatment Study 

1. Trial Details/Purpose

Obesity affects 42.4% of U.S. adults, with 9% experiencing severe obesity. 19.7% of children are obese, particularly impacting Hispanic and Black populations. Obesity contributes to heart failure, which affects 6.2 million adults, with 900,000 new cases annually. It is a key risk factor for HFpEF, contributing to over 50,000 deaths annually. The STEP-HFpEF trial evaluated semaglutide 2.4 mg for improving symptoms, physical function, and body weight in 529 adults with HFpEF and obesity. The study measured changes in KCCQ-CSS, body weight, 6MWD, and C-reactive protein over 52 weeks.​

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​2. Inclusion Criteria

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• Adults aged ≥18 years.

• Diagnosed with symptomatic HFpEF, defined by:

• Left ventricular ejection fraction (LVEF) ≥45%.

• New York Heart Association (NYHA) functional class II-IV symptoms.

• Elevated N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels.

• BMI ≥30 kg/m².

• Stable heart failure therapy for at least 30 days prior to screening

3. Exclusion Criteria

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• Hospitalization for heart failure within 30 days prior to screening.

• Significant weight loss or gain (>5 kg) within 90 days prior to screening.

• Planned or previous bariatric surgery.

• Uncontrolled hypertension (systolic blood pressure ≥160 mmHg).

• Recent cardiovascular events, such as myocardial infarction, stroke, or transient ischemic attack within 90 days prior to screening.

• Severe renal impairment (estimated glomerular filtration rate <30 mL/min/1.73 m²).

• History of pancreatitis or significant gastrointestinal disorders.

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​4. Benefits of Participation

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• Participants may be compensated for time and travel.

• No personal insurance is necessary.

• Participants will receive study medication at no cost.

• Before and during the study, qualified participants will meet with board-certified physicians and highly-trained and skilled research staff and receive one-on-one care.

​5. Study Location​

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     Huntington Park