A Study of Tirzepatide (LY3298176) in Participants With Heart Failure With Preserved Ejection Fraction and Obesity (SUMMIT)

• Status: Recruiting
• Trial end date: 2023-11-22
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of this study is to assess the efficacy and safety of Tirzepatide (LY3298176) in participants with heart failure with preserved ejection fraction and obesity.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: LY3298176; Tirzepatide

Criteria

Inclusion Criteria:

• Have a diagnosis of stable heart failure (NYHA class II-IV) and left ventricular ejection fraction (LVEF) ≥50%

• Elevated NT-proBNP (N-terminal pro B-type natriuretic peptide) > 200 pg/ml for participants without atrial fibrillation (AF), or >600 picogram/milliliter (pg/ml) for participants with AF, Structural heart disease (Left atrial enlargement) or Elevated left ventricular filling pressure

• Estimated glomerular filtration rate (eGFR) <70 milliliter (ml)/minute (min)/1.73m² at screening, or HF decompensation within 12 months of screening,

• Stable dose of heart failure medications within 4 weeks of screening

• Body mass index (BMI) ≥30 kilograms per meter squared (kg/m²)

• 6MWD 100-425m

• KCCQ CSS ≤80

Exclusion Criteria:

• Have had a major cardiovascular event within the last 90 days of screening

• Have had acute decompensated heart failure within 4 weeks of screening

• Have non cardiac causes of functional impairment such as pulmonary arterial hypertension (PAH), severe chronic obstructive pulmonary disease (COPD), anemia, thyroid disease, musculoskeletal disease or orthopedic conditions

• Presence of cardiac amyloidosis, cardiac accumulation disease, cardiomyopathy and severe valvular hear disease

• HbA1c ≥9.5% or uncontrolled diabetes

• History of proliferative diabetic retinopathy or diabetic maculopathy

• Have a history of pancreatitis

• eGFR <15 mL/min/1.73 m² or requiring dialysis at screening