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CTRI Number  CTRI/2022/01/039282 [Registered on: 10/01/2022] Trial Registered Prospectively
Last Modified On: 22/08/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Patients with Heart Failure with Preserved Ejection Fraction and Obesity 
Scientific Title of Study   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 Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
I8F-MC-GPID protocol dated 13/Jan/2021  Protocol Number 
NCT04847557  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Dr Manish Mistry 
Designation  Medical Director 
Affiliation  Eli Lilly and Company (India) Pvt. Ltd. 
Address  Plot No - 92, Sec - 32, Institutional Area, Gurgaon HARYANA-122001 India

Gurgaon
HARYANA
122001
India 
Phone  9820234897  
Fax    
Email  manish.mistry@lilly.com  
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Dr Manish Mistry 
Designation  Medical Director 
Affiliation  Eli Lilly and Company (India) Pvt. Ltd. 
Address  Plot No - 92, Sec - 32, Institutional Area, Gurgaon HARYANA-122001 India


HARYANA
122001
India 
Phone  9820234897  
Fax    
Email  manish.mistry@lilly.com  
 
Details of Contact Person
Public Query  
Name  Dr Rajeev Sharan Shrivastava 
Designation  Associate Director 
Affiliation  Eli Lilly and Company (India) Pvt. Ltd. 
Address  Plot No - 92, Sec - 32, Institutional Area, Gurgaon HARYANA-122001 India

Gurgaon
HARYANA
122001
India 
Phone  9810308697  
Fax    
Email  shrivastava_rajeev_sharan@lilly.com  
 
Source of Monetary or Material Support  
Eli Lilly and Company (India) PVT LTD, Plot No. 92, Sector-32, Gurgaon, Haryana - 122001 
 
Primary Sponsor  
Name  Eli Lilly and Company India Pvt Ltd 
Address  Eli Lilly and Company (India) PVT LTD, Plot No. 92, Sector-32, Gurgaon, Haryana - 122001 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Argentina
Brazil
China
India
Israel
Mexico
Russian Federation
Taiwan
United States of America  
Sites of Study
Modification(s)  
No of Sites = 10  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Narasimhan Calambur  AIG Hospitals  Plot No 2/3/4/5, Survey No 136, 1, Mindspace Rd, Gachibowli, Hyderabad, Telangana 500032 India
Hyderabad
TELANGANA 		 9618528340

calambur1@gmail.com 
Dr Upendra Kaul  Batra Hospital and Medical Research Centre  1 Tughlakabad Institutional Area, 1st Floor, Room no. 17, New Delhi, Delhi, 110062 India
New Delhi
DELHI 		 9811150518

upendra.kaul@batrahospitaldelhi.org 
Dr Anil Jawahirani  Central India Cardiology and Research Institute  Pioneer Co-Op Housing Society Plot No 1, Gawande Lay Out Khamla Ring Road, Nagpur, Maharashtra, 440015 India
Nagpur
MAHARASHTRA 		 9822220936

drjawahirani01@gmail.com 
Dr Urmil Shah  CIMS Hospital - Care Institute of Medical Sciences  Opp Panchamrut Bunglows, near Shukan mall, Off Science City Road, Ahmedabad, Gujarat, 380060 India
Ahmadabad
GUJARAT 		 9825066939

urmil.shah@cimshospital.org 
Dr Vimal Mehta  G.B. Pant Institute of Postgraduate Medical Education & Research  Room No-133, First Floor, Academic Block, Department of Car, New Delhi, Delhi, 110002 India
New Delhi
DELHI 		 9718599105

drvimalmehta@yahoo.co.in 
Dr Vinod Khandait  Government Medical College And Hospital - Nagpur  Hanuman Nagar, Nagpur, Maharashtra, 440009 India
Nagpur
MAHARASHTRA 		 9373107740

drvinodresearch11@gmail.com 
Dr Prafulla Kerkar  King Edward Memorial Hospital & Seth Gordhandas Sunderdas Medical College  K.E.M Hospital & Seth G. S Medical College, CVTC Building D, 4th Floor, Department of Cardiology, Mumbai, Maharashtra, 400012 India
Mumbai
MAHARASHTRA 		 9820144111

prafullakerkar@rediffmail.com 
Dr Ravi Rattan Kasliwal  Medanta The Medicity  Medanta Institute of Education & Research Department, CH Baktawar, 10th Floor, A - Wing (POCU Unit), Gurugram, Haryana, 122018 India
Gurgaon
HARYANA 		 9971698148

rr.kasliwal@medanta.org 
Dr Bagirath Raghuraman  Narayana Institute of Cardiac Sciences  258/A Bommasandra Industrial Area, Anekal Taluk, Bangalore, Karnataka, 560099 India
Bangalore
KARNATAKA 		 9845144830

bagrag21@gmail.com 
Dr Vinod Vijan  Vijan Hospital and Research Centre  Department of Cardiology, Dr. Vijan Hospital Marg, College Road, Nashik, Maharashtra, 422005 India
Nashik
MAHARASHTRA 		 9822025353

vmvijan@hotmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 10  
Name of Committee  Approval Status 
Ethics Committee of Care Institute of Medical Sciences  Approved 
IEC Rughwani Child Care Centre and Hospital  Approved 
Institutional Ethics Committee (IEC), Department of Pharmacology, Govt. Medical College  Approved 
Institutional Ethics Committee Asian Institute of Gastroenterology  Approved 
Institutional Ethics Committee, KEM Hospital  Approved 
Institutional Ethics Committee, MAMC  Approved 
Medanta Institute of Ethics Committee  Approved 
Narayana Health Medical Ethics Committee  Approved 
Scientific Research and Ethical Review Committee, Batra Hospital and Medical Research Centre  Approved 
Vijan Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Notified 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I504||Combined systolic (congestive) anddiastolic (congestive) heart failure,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo  Per-single dose pen Placebo administered subcutaneous (SC). The study will last about 52 weeks. 
Intervention  Tirzepatide  Starting dose of 2.5mg Tirzepatide and escalated at 4 weeks intervals to 15 mg Tirzepatide administered subcutaneous (SC). The study will last about 52 weeks. 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  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. 
 
ExclusionCriteria 
Details  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. 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Centralized 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
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.
2. Change from Baseline in Exercise Capacity as Measured by 6MWD 		 1. 120 Weeks.
2. Week 52 
 
Secondary Outcome  
Outcome  TimePoints 
1. Percent Change from Baseline in Body Weight Loss.
2. Change from Baseline in the KCCQ CSS. 		 Baseline Week 52 
Change from Baseline in 6MWD.  Baseline Week 24 
Percentage of Participants with New York Heart Association (NYHA) Class Change.  Week 52 
 
Target Sample Size   Total Sample Size="700"
Sample Size from India="54" 
Final Enrollment numbers achieved (Total)= "731"
Final Enrollment numbers achieved (India)="20" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   12/01/2022 
Date of Study Completion (India) 02/07/2024 
Date of First Enrollment (Global)  20/04/2021 
Date of Study Completion (Global) 02/07/2024 
Estimated Duration of Trial   Years="1"
Months="10"
Days="10" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) -  www.vivli.org/

  6. For how long will this data be available start date provided 01-01-2022 and end date provided 30-06-2022?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
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. 
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