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Clinical Trials/CTRI/2022/01/039282
CTRI/2022/01/039282
Completed
Phase 3

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Comparing the Efficacy and Safety of Tirzepatide versus Placebo in Patients with Heart Failure with Preserved Ejection Fraction and Obesity (SUMMIT)

Eli Lilly and Company India Pvt Ltd10 sites in 1 country700 target enrollmentStarted: December 1, 2022Last updated:
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Overview

Phase
Phase 3
Status
Completed
Sponsor
Eli Lilly and Company India Pvt Ltd
Enrollment
700
Locations
10
Primary Endpoint
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.
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Stratified randomization
Masking
Double Blind Double Dummy

Eligibility Criteria

Ages
40.00 Year(s) to 99.00 Year(s) (—)
Sex
All

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.
  • •4.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.

Outcomes

Primary Outcomes

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.

Time Frame: 1. 120 Weeks. | 2. Week 52

2. Change from Baseline in Exercise Capacity as Measured by 6MWD

Time Frame: 1. 120 Weeks. | 2. Week 52

Secondary Outcomes

  • 1. Percent Change from Baseline in Body Weight Loss.(2. Change from Baseline in the KCCQ CSS.)
  • Percentage of Participants with New York Heart Association (NYHA) Class Change.(Week 52)
  • Change from Baseline in 6MWD.(Baseline Week 24)

Investigators

Sponsor
Eli Lilly and Company India Pvt Ltd
Sponsor Class
Pharmaceutical industry-Global

Study Sites (10)

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