| CTRI Number |
CTRI/2023/04/051445 [Registered on: 10/04/2023] 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
|
The effect of Tirzepatide once weekly on the morbidity and mortality of adults living with obesity. |
|
Scientific Title of Study
|
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Effect of Tirzepatide on the Reduction of Morbidity and Mortality in Adults with Obesity |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| I8F-MC-GPIJ dated 14 Jun 2022 |
Protocol Number |
| NCT05556512 |
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
Gurgaon
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
|
|
|
Countries of Recruitment
|
Argentina
Australia
Austria
Belgium
Brazil
Canada
China
Czech Republic
France
Germany
Greece
Hungary
India
Israel
Italy
Japan
Mexico
Netherlands
Poland
Republic of Korea
Slovakia
Spain
Taiwan
Turkey
United Kingdom
United States of America |
Sites of Study
Modification(s)
|
| No of Sites = 11 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Gurpreet Singh Wander |
Dayanand Medical College & Hospital |
Dayanand Medical College & Hospital, Unit Hero DMC Heart Institute, Tagore Nagar, Civil Lines, Ludhiana – 141001, Punjab
Ludhiana
PUNJAB |
01612304282
drgswander@yahoo.com |
| Dr Vimal Mehta |
G B Pant Institute of Postgraduate Medical Education and Research |
Room No. 133, 1st Floor, Academic Block, Department of Cardiology, G.B. Pant Institute of Postgraduate Medical Education & Research, Jawahar Lal Nehru Marg, New Delhi, 110002, India
New Delhi
DELHI |
9718599105
drvimalmehta@yahoo.co.in |
| Dr Hemant Ramsharan Gupta |
Grant Government Medical College |
OPD No. 20, Department of Internal Medicine, Old OPD Building, Byculla, Mumbai-400008
Mumbai
MAHARASHTRA |
9870456888
drhemantgupta@hotmail.com |
| Dr Parag Rajnikant Shah |
Gujarat Endocrine Center |
2nd Floor, Silver Brook B, Opposite Doctor House, Nr. Parimal Crossing, Ahmedabad, Gujarat - 380006
Ahmadabad
GUJARAT |
9824042688
paragendocrine@yahoo.com |
| Dr Ajay Mahajan |
K.E.M Hospital & Seth G. S. Medical College |
4th Floor, CVTC Building, Department of Cardiology, Acharya Donde Marg, Parel 400012 Mumbai, Maharashtra, India
Mumbai
MAHARASHTRA |
9920432639
draumahajan@gmail.com |
| Dr Gaurav Kumar Chaudhary |
King Georges Medical University |
Department of Cardiology, King George’s Medical University Lucknow-226003, India
Lucknow
UTTAR PRADESH |
9936062507
gauravchaudharydr@gmail.com |
| Dr Shailendra Ramakant Ganjewar |
Kingsway Hospital |
44 Kingsway, Near Kasturchand Park, Nagpur, Maharashtra, India, 440001
Nagpur
MAHARASHTRA |
8149830032
shailendra.ganjewar@kingswayhospitals.com |
| Dr Piyush Desai Harshadrai |
Nirmal Hospital Private Limited |
Ring Road, Surat- 395002, Gujarat, India
Surat
GUJARAT |
9825144453
drpiyushdesai@gmail.com |
| Dr Rakesh Kumar Sahay |
Osmania General Hospital |
Department of Endocrinology, Room No: 310, 2nd Floor, Golden Jubilee Block, Osmania Medical College & Osmania General Hospital, Afzalgunj, Hyperabad, Telangana, 50012, India
Hyderabad
TELANGANA |
9849597507
sahayrk@gmail.com |
| Dr Devendra Kumar Agarwal |
Sardar Patel Medical College And A G Hospitals |
Sardar Patel Medical College And A. G. Hospitals, Bikaner- 334003, Rajasthan, India
Bikaner
RAJASTHAN |
9829217899
tippy1234@rediffmail.com |
| Dr Atul Damodar Abhyankar |
Shri B D Mehta Mahavir Heart Institute |
Shree Mahavir Health Campus, Athwa gate, Ring Road, OPD Area, Surat, Gujarat, India, 395001
Surat
GUJARAT |
9825145738
atulda@hotmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 11 |
| Name of Committee |
Approval Status |
| Drug Trial Ethics Committee |
Approved |
| Ethics Committee, S P Medical College |
Approved |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee, GGMC, Mumbai |
Approved |
| Institutional Ethics Committee, MAMC |
Approved |
| Institutional Ethics Committee, Osmania Medical College |
Approved |
| Kingsway Hospitals Ethics Committee |
Approved |
| Nirmal Hospital Private Limited Ethics Committee |
Approved |
| Sangini Hospital Ethics Committee |
Approved |
| Shri B D Mehta Mahavir Heart Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E669||Obesity, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
2.5 mg placebo injected subcutaneously once weekly. The dose will increase 2.5 mg every 4 weeks until 15 mg. The study will last about 5 years. |
| Intervention |
Tirzepatide |
2.5 mg Tirzepatide injected subcutaneously once weekly. The dose will increase 2.5 mg every 4 weeks until 15 mg. The study will last about 5 years. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Have a body mass index (BMI) ≥27.0 kilogram/square meter (kg/m ²)
2. Are either
-individuals ≥40 years of age with established cardiovascular disease (CVD).
-CVD is defined as meeting at least one of the following:
Coronary artery disease
Cerebrovascular disease
-Peripheral arterial disease OR
-individuals without established CVD but have the presence of cardiovascular (CV) risk factors (primary prevention):
--women 55-69 years of age or men 50-64 years of age with at least 3 risk factors like tobacco use, dyslipidemia, hypertension at screening, or
--women ≥70 years of age or men, ≥65 years of age with at least 2 risk factors at screening.
|
|
| ExclusionCriteria |
| Details |
1. Have type 1 diabetes (T1D) or (T2D), history of ketoacidosis, or hyperosmolar state/coma
2. Have laboratory evidence diagnostic of diabetes mellitus at screening of HbA1c ≥6.5% (≥48 millimole/mole (mmol/mol) or fasting glucose (FG) ≥126 milligram/deciliter (≥7.0 millimole/liter (mmol/L).
3. Any one of the following CV conditions within 90 days prior to screening
-MI
-acute coronary syndrome
-stroke
-coronary or peripheral arterial revascularization procedure, which may also include carotid artery revascularization, or
-acute decompensated heart failure
4. Have a known clinically significant gastric emptying abnormality such as severe gastroparesis or gastric outlet obstruction or have undergone or currently planning any gastric bypass (metabolic) surgery or restrictive bariatric surgery. Note: Liposuction or abdominoplasty are not considered as gastric bypass procedures.
5. Have a history of chronic or acute pancreatitis
6. Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2.
7. Have acute or chronic hepatitis, or clinical signs or symptoms of any other liver disease, or have elevated liver enzyme measurements, determined by the central laboratory at screening
8. Have a presence or history of malignant neoplasms within the past 5 years prior to screening. |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time to First Occurrence of Any Component Event of Composite (All-Cause Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, Coronary Revascularization, or Heart Failure Events) |
Up to 5 Years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Time to Onset of Type 2 Diabetes (T2D)
2. Time to First Occurrence of Any Component Event of Major Adverse Cardiovascular Events-3 (MACE-3) (CV Death, Nonfatal MI or Nonfatal Stroke)
3. Time to the Occurrence of All-cause Death
4. Time to First Occurrence of CV Death
5. Time to First Occurrence of MI
6. Time to First Occurrence of Stroke
7. Time to First Occurrence of Coronary Revascularization
8. Time to First Occurrence Heart Failure (HF) Events
9. Time to First Occurrence of Hospitalization for Unstable Angina
10. Time to first occurrence of Hospitalization or Urgent Visit
11. Time to First Occurrence of Any Component Event of the Composite Endpoint (eGFR, ESRD, or Renal Death)
12. eGFR Slope
13. Percentage of Participants with Hemoglobin A1c (HbA1c) less than 39 Millimole/Mole (mmol/mol) (5.7%) |
Up to 5 Years |
| Hierarchical Composite of Renal Death or End-Stage Renal Disease (ESRD), Sustained Decline in Estimated Glomerular Filtration Rate (eGFR), and eGFR Slope |
Baseline (Week 0) to Study Completion up to 5 Years. |
| Mean Change from Baseline Short Form-36 Version 2 (SF-36 v2) Acute Form Physical Functioning Domain Score |
Baseline, 2 Years |
1. Percent Change from Baseline in Body Weight
2. Change from Baseline in Systolic Blood Pressure (SBP) in Millimeter Mercury (mmHg)
3. Change from Baseline Diastolic Blood Pressure (DBP) (mmHg) |
Baseline, 156 weeks |
|
|
Target Sample Size
|
Total Sample Size="15000"
Sample Size from India="180"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
10/04/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
11/10/2022 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="4"
Months="5"
Days="27" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- 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).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- 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.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response (Others) - www.vivli.org
- For how long will this data be available start date provided 01-03-2023 and end date provided 31-08-2023?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study will investigate the effect of tirzepatide on the reduction of morbidity and mortality in adults living with obesity and provide additional evidence for the potential clinical benefits of tirzepatide in this population. |