CTRI/2025/12/099605 [Registered on: 22/12/2025] Trial Registered Prospectively
Last Modified On:
12/08/2026
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Single Arm Study
Public Title of Study
A Study of Tirzepatide in Adults with Diabetes or Obesity
Scientific Title of Study
A Phase 4, Open-Label, Single-Arm, 46-Week Study to Investigate the Safety and Efficacy with Tirzepatide in Adult Indian Participants with Either Type 2 Diabetes or Obesity
Clinical Research Room, Department of General Medicine
Rajendra Prasad Ward, King George Hospital, Andhra Medical College, Maharanipeta, Vishakhapatnam-530002, Andhra Pradesh, India Visakhapatnam ANDHRA PRADESH
9393104578
drvsatyaprasadresearch@gmail.com
Dr Balamurugan Ramanathan
Kovai Diabetes Speciality Centre & Hospital
No.15, Vivekananda Road, Ramnagar, Coimbatore- 641009 Coimbatore TAMIL NADU
9842244881
rbmkdsc@gmail.com
Dr L Sreenivasa Murthy
Lifecare Hospital and Research Centre
2748/2152,M.L.N Enclave,16th E- cross Road, 8th Main,D lock, next to Union Bank of India, Sahakara Nagar, Bangalore, Karnataka 560092 Bangalore KARNATAKA
9448051046
drlsm@Icrc.in
Dr Jitendra Shukla
Motilal Nehru Medical college Prayagraj
George Town Road, George Town, Prayagraj, Uttar Pradesh 211002 Allahabad UTTAR PRADESH
8527483333
drjeetendramln@gmail.com
Dr Rakesh Sahay
Osmania Medical Hospital & Osmania General Hospital
Department of Endocrinology, 2nd Floor, Golden Jubilee Block, Afzalgunj, Hyderabad-500012, India Hyderabad TELANGANA
9849597507
sahayrk@gmail.com
Dr Shashank Shah
Sahyadri Super Speciality Hospital
Plot Number 30-C, Erandwane, Karve Road, Deccan Gymkhana, Pune, Maharashtra, India-411004, Pune, Maharashtra, India Pune MAHARASHTRA
9822026734
drshashanks@gmail.com
Dr Mahesh Chandumal Fulwani
Shrikrishna Hrudayalaya and Critical Care Centre
Tikekar Road, Congress Nagar square, Dhantoli, Nagpur-440012, Maharashtra, India. Nagpur MAHARASHTRA
9921120005
drmaheshfulwani@gmail.com
Dr Sudagar Singh
Sri Ramachandra Hospital
No.1 Ramachandra Nagar, Porur
Chennai, Tamil Nadu, India 600116 Chennai TAMIL NADU
9003178899
drsingh7071@gmail.com
Dr Ramen Goel
Wockhardt Hospitals Ltd.
Unit-Adams Wylie Memorial, 1877, Dr Anandrao Nair Marg, Mumbai Central, Mumbai- 400011, Maharashtra, India Mumbai MAHARASHTRA
9820170763
ramengoel@gmail.com
Details of Ethics Committee
No of Ethics Committees= 20
Name of Committee
Approval Status
Eternal Heart Care Centre and Res Inst - IEC
Approved
Ethics Committee Atmaram Child Care and Critical Care
Approved
Ethics Committee Brij Medical Centre
Approved
ILS HOSPITAL ETHICS COMMITTEE
Approved
INSTITUTE ETHICS COMMITTEE, AIIMS RAIPUR
Approved
Institutional Ethics Committee - B. J. Medical College and Civil Hospital
Participants will receive tirzepatide subcutaneously (SC)
Inclusion Criteria
Age From
18.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
Participants with Type 2 Diabetes:
1. Have had type 2 diabetes for at least one year
2. Insulin naive
3. Have HbA1c more than or equal to 7.5% and less than or equal to 10% at screening
4. Have body mass index (BMI) more than or equal to 23 kilograms per square meter (kg/m2)
Participants with Obesity or Overweight without Type 2 Diabetes:
1. Have a BMI
2. Greater than or equal to 30 kg/m2 OR
3. Greater than or equal to 27 kg/m2 AND previously diagnosed with at least one of the following weight-related comorbidities: high blood pressure, lipid disorder, obstructive sleep apnea, heart disease
ExclusionCriteria
Details
Participants with Type 2 Diabetes:
1. Have type 1 diabetes
2. Have had any of the following heart conditions within 6 months prior to screening: a) heart attack, b) stroke, c) hospitalization due to heart failure
3. Have New York Heart Association Functional Classification Class III or IV congestive heart failure (CHF)
4. Have type 2 diabetes along with morbid obesity and being considered for bariatric surgery or any other procedure intended for weight loss
Participants with Obesity or Overweight without Type 2 Diabetes:
1. Have type 1 diabetes or type 2 diabetes
2. Have a self-reported change in body weight greater than 5 kilograms (kg) (11 pounds) within 3 months prior to screening
3. Have a prior or planned surgical treatment for obesity
4. Have had any of the following heart conditions within 6 months prior to screening: a) heart attack, b) stroke, c) hospitalization due to heart failure
5. Have New York Heart Association Functional Classification Class III or IV CHF
6. Have taken any medications or alternative remedies for weight loss within 3 months prior to screening
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Number of Participants with One or More Serious Adverse Events (SAE) Considered by the Investigator to be Related to Study Drug Administration
Baseline through Week 46
Secondary Outcome
Outcome
TimePoints
1. Percentage of Participants with more than or equal to 5% Body Weight Reduction
2. Percentage of Participants with Hemoglobin A1c (HbA1c) less than 7.0% in Participants with Type 2 Diabetes
3. Change from Baseline in Waist Circumference in Participants with Obesity or Overweight
1. Week 46
2. Week 46
3. Baseline, Week 46
Target Sample Size
Total Sample Size="172" Sample Size from India="172" 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 4
Date of First Enrollment (India)
01/02/2026
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="1" Months="9" Days="10"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Open to Recruitment
Publication Details
N/A
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 01-02-2026 and end date provided 11-11-2027? Response (Others) - Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting
Any URL or additional information regarding plan/policy for sharing IPD? Additional Information - NIL
Brief Summary
The main purpose of this study is to measure the safety and efficacy of tirzepatide in adult participants in India who have type 2 diabetes or who have obesity or overweight without type 2 diabetes. Participation in the study will last about 46 weeks.