The headline trial: STEP-HFpEF + SUMMIT
STEP-HFpEF (Semaglutide in Patients with Heart Failure with Preserved Ejection Fraction and Obesity) and SUMMIT (Tirzepatide for Heart Failure with Preserved Ejection Fraction and Obesity)
STEP-HFpEF: Kosiborod et al., NEJM August 2023. SUMMIT: published NEJM November 2024.
STEP-HFpEF: semaglutide 2.4 mg weekly improved heart-failure symptoms (KCCQ-CSS) by 7.8 points more than placebo and reduced body weight by 10.7 percentage points more, over 52 weeks. SUMMIT: tirzepatide reduced the composite of cardiovascular death or worsening heart failure by 38 percent (hazard ratio 0.62, 95% CI 0.41–0.95) over a median 104 weeks in patients with HFpEF and obesity.
Trial enrollment criteria
- Adults with HFpEF (left ventricular ejection fraction ≥45 percent)
- BMI greater than or equal to 30
- Stable diuretic regimen for at least 30 days
- NYHA class II to IV symptoms
Does this trial apply to you?
If you have echocardiogram-documented HFpEF (EF preserved at 45 percent or higher) AND BMI 30 or higher, you may meet STEP-HFpEF / SUMMIT enrollment criteria. The HFpEF indication is not yet an FDA-labeled indication for either drug; the obesity-with-comorbidity indication is the standing FDA-labeled path.
What to ask your prescriber
- Most recent echocardiogram results (ejection fraction, diastolic function parameters)
- NYHA class and recent KCCQ-CSS score if available
- BNP or NT-proBNP trajectory
- Whether the prescribing cardiologist would be willing to write the PA under the obesity-with-comorbidity indication (E66 + I50.3x)
Editorial notes
- Several major payers (Aetna, BCBS affiliates) updated their PA criteria in late 2024 to recognize HFpEF + obesity as a stronger justification under the obesity-with-comorbidity indication.
- The cardiovascular indication for Wegovy (SELECT, ASCVD) is a separate pathway from HFpEF and uses different ICD-10 codes.
- Diuretic doses often need adjustment during initial weight loss; coordinate with your cardiologist.
Clinical trials for Heart failure with preserved ejection fraction (HFpEF) and obesity
Or browse the full GLP-1 clinical trials directory, filterable by condition, state and phase.
Take it to your prescriber: PA letter templates
Editable prior-authorization letter templates that cite the registration trial above. Pick the plan your prescriber will submit to, copy the template, fill in the patient-specific findings and have your clinician sign and submit.
Not seeing your plan? The full PA letter librarycovers 20 plans × 10 indications = 200 templates. The appeal letter library handles denials.
Drug profiles
Other GLP-1 conditions
Editorial provenance
Editorial review by John, Editor on 2026-05-23, against STEP-HFpEF + SUMMIT (STEP-HFpEF: Kosiborod et al., NEJM August 2023. SUMMIT: published NEJM November 2024.). We do not yet have a credentialed medical reviewer on staff (actively recruiting). This page summarises public registration-trial data and FDA labeling. It is not clinician-authored medical advice.
Disclaimer
Educational summary of published registration trial data. Not medical advice. Not a substitute for evaluation by a treating clinician. Trial-level results do not guarantee individual outcomes. Discuss eligibility, contraindications, dose adjustments and drug interactions with your prescriber. We do not have a credentialed medical reviewer on staff yet (actively recruiting); the content below is editor-written from public registration-trial publications and FDA labeling, not clinician-authored medical advice.