Patients with Heart Failure withPreserved Ejection Fraction and Obesity

Phase 3

Conditions: Health Condition 1: I504- Combined systolic (congestive) anddiastolic (congestive) heart failure

Registration Number: CTRI/2022/01/039282

Lead Sponsor: Eli Lilly and Company India Pvt Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

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

2. 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.

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

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

5. Body mass index (BMI) =30 kilograms per meter squared (kg/m²).

6. 6MWD 100-425m.

7. KCCQ CSS =80.

Exclusion Criteria

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

2. Have had acute decompensated heart failure within 4 weeks of screening.

3. 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.

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

5. HbA1c =9.5% or uncontrolled diabetes.

6. History of proliferative diabetic retinopathy or diabetic maculopathy.

7. Have a history of pancreatitis.

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. A Hierarchical Composite of All-Cause Mortality, Heart Failure Events, 6-minute Walk Test Distance (6MWD) and Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS) Category. <br/ ><br>2. Change from Baseline in Exercise Capacity as Measured by 6MWDTimepoint: 1. 120 Weeks. <br/ ><br>2. Week 52

Secondary Outcome Measures

Name	Time	Method
1. Percent Change from Baseline in Body Weight Loss. <br/ ><br>2. Change from Baseline in the KCCQ CSS.Timepoint: Baseline Week 52;Change from Baseline in 6MWD.Timepoint: Baseline Week 24;Percentage of Participants with New York Heart Association (NYHA) Class Change.Timepoint: Week 52