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NCT04847557COMPLETEDanonymous

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)

Sponsor

Source record

Eli Lilly and Company

Phase

Source record

Phase 3

Modality

AI-normalized

small molecule

Target

AI-normalized

Tirzepatide (LY3298176) is a dual GIP and GLP-1 receptor agonist, targeting metabolic pathways involved in glucose regulation and weight management, which may also have beneficial effects on heart failure outcomes.

Indication / condition

AI-normalized

Obesity

Intervention

Source record

Tirzepatide, Placebo

Source & freshness

Source record

NCT ID

NCT04847557

Original source

ClinicalTrials.gov

Source last updated

Aug 20, 2025

Ingested at

Jun 19, 2026

Internal sync

Jun 19, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

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NCT ID

NCT04847557

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)

Sponsor

Eli Lilly and Company

Status

COMPLETED

Phase

Phase 3

Condition raw

Obesity, Heart Failure With Preserved Ejection Fraction (HFpEF)

Condition normalized

Obesity, Heart Failure With Preserved Ejection Fraction (HFpEF)

Modality raw

small molecule

Modality normalized

small molecule

Target raw

Tirzepatide (LY3298176) is a dual GIP and GLP-1 receptor agonist, targeting metabolic pathways involved in glucose regulation and weight management, which may also have beneficial effects on heart failure outcomes.

Target normalized

Tirzepatide (LY3298176) is a dual GIP and GLP-1 receptor agonist, targeting metabolic pathways involved in glucose regulation and weight management, which may also have beneficial effects on heart failure outcomes.

Interventions

Tirzepatide, Placebo

Public preview

Source record

The SUMMIT trial aims to establish the efficacy and safety of Tirzepatide in patients with heart failure with preserved ejection fraction (HFpEF) and obesity. Given the increasing prevalence of obesity and heart failure, successful outcomes could position Tirzepatide as a significant therapeutic option in a market projected to grow substantially. Competitive analysis indicates that while several therapies are targeting HFpEF, Tirzepatide's dual mechanism may provide a unique selling proposition. Diligence should focus on the trial's primary and secondary endpoints, as well as potential regulatory pathways and reimbursement considerations.

AI-generated analysis supports research triage only. Verify source records, publications, sponsor disclosures and IP databases before making diligence decisions. Model: trialsignal-ai-v1.

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