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Clinical Trials List

Protocol NumberI8F-MC-GPID
NCT Number(ClinicalTrials.gov Identfier)NCT04847557
Completed

2021-04-20 - 2024-07-02

Phase III

Recruiting7

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)

  • Trial Applicant

    ELI LILLY AND COMPANY(TAIWAN), INC.

  • Sponsor

    Lilly

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator 翁國昌 Division of Cardiovascular Diseases
Chung Shan Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Tzung-Dau Wang Division of Cardiovascular Diseases
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator I-Chang Hsieh Division of Cardiovascular Diseases
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chun-Yao Huang Division of Cardiovascular Diseases
Taipei Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Tsung-Hsien Lin Division of Cardiovascular Diseases
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 劉銘恩 Division of Cardiovascular Diseases
Hsinchu Mackay Memorial Hospital

Co-Principal Investigator

  • 楊翔惟 Division of Cardiovascular Diseases
  • 劉俞旻 Division of Cardiovascular Diseases
  • 陳永強 Division of Cardiovascular Diseases
  • 吳敘平 Division of Cardiovascular Diseases
  • 賴堯暉 Division of Cardiovascular Diseases
  • 林柏霖 Division of Cardiovascular Diseases

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Shih-Hsien Sung 臨床試驗科
Taipei Veterans General Hospital

Taiwan National PI

Chern-En Chiang

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Heart Failure with Preserved Ejection Fraction and Obesity

Objectives

Study GPID is a randomized, outpatient, multicenter, international, placebo-controlled, doubleblind, parallel-arm, Phase 3 study with 2 study periods. The study is designed to evaluate the efficacy and safety of SC QW tirzepatide, MTD up to 15 mg, compared to placebo, in participants with HFpEF and obesity.

Test Drug

Tirzepatide

Active Ingredient

LY3298176

Dosage Form

injection

Dosage

2.5/ 5/ 7.5/10 /12.5 /15

Endpoints

To demonstrate that a maximally tolerated tirzepatide dose up to 15 mg administered subcutaneously once weekly (SC QW) is superior to placebo based on the hierarchal composite endpoint in participants with HFpEF and BMI ≥30 kg/m2.
To demonstrate that a maximally tolerated tirzepatide dose up to 15 mg administered SC QW is superior to placebo to improve exercise capacity in participants with HFpEF and BMI ≥30 kg/m2.

Inclution Criteria

1. Participant must be at least 40 years of age inclusive, at the time of signing the ICF.
2. 6MWD ≤465 meters at both Visit 1 tests, between ≥100 meters and ≤425 meters at Visit 2, and change from the preceding qualifying 6MWD is <20% and <40 meters.
3. Chronic HF (NYHA Class II-IV) diagnosed for at least 3 months before Visit 1
4. LVEF ≥50% demonstrated by echocardiogram performed at Visit 1 or within 6 months of Visit 1

Exclusion Criteria

Myocardial infarction, coronary artery bypass graft surgery, or other major CV surgery/intervention, stroke or transient ischemic attack in past 90 days, or unstable angina pectoris in past 30 days, prior to Visit 1 or during screening
Dominant contribution of noncardiac causes to exercise impairment or symptoms
LVEF <40% by local echocardiography documented any time within 2 years of Visit 1
Acute decompensated HF (exacerbation of HF) requiring IV diuretics, IV inotropes, or IV vasodilators, or left ventricular assist device (LVAD) within 4 weeks prior to Visit 1, and/or during the screening period until randomization
Impaired renal function, defined as eGFR <15 mL/min/1.73 m2 (CKD-EPI) or requiring dialysis at Visit 1

The Estimated Number of Participants

  • Taiwan

    70 participants

  • Global

    700 participants

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