Summary

Eligibility
for people ages 40 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Kimberly Hong

Description

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.

Official Title

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)

Details

The study will continue until approximately 52 weeks after the last participant is randomized. The maximum duration of an individual's participation is estimated to be 120 weeks and will depend on duration of study enrollment.

Keywords

Obesity Heart Failure With Preserved Ejection Fraction Heart Failure with Preserved Ejection Fraction (HFpEF) Heart Failure LY3298176 Tirzepatide

Eligibility

You can join if…

Open to people ages 40 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • University of California San Diego - La Jolla not yet accepting patients
    La Jolla California 92037 United States
  • California Heart Specialists not yet accepting patients
    Huntington Beach California 92648 United States

Lead Scientist at UCSD

  • Kimberly Hong
    Assistant Clinical Professor, Medicine. Authored (or co-authored) 31 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Eli Lilly and Company
Links
A Study of Tirzepatide (LY3298176) in Participants With Heart Failure With Preserved Ejection Fraction and Obesity (SUMMIT)
ID
NCT04847557
Phase
Phase 3
Study Type
Interventional
Last Updated