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CTRI Number  CTRI/2022/07/044269 [Registered on: 22/07/2022] Trial Registered Prospectively
Last Modified On: 11/09/2026
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 safety and efficacy of tirzepatide in children or teenagers with type 2 diabetes 
Scientific Title of Study   A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study with an Open-Label Extension Assessing the Efficacy, Safety, and Pharmacokinetics/Pharmacodynamics of Tirzepatide in Pediatric and Adolescent Participants with Type 2 Diabetes Mellitus Inadequately Controlled with Metformin, or Basal Insulin, or Both (SURPASS-PEDS) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
I8F-MC-GPGV Version No.1 dated 14/Dec/2021  Protocol Number 
NCT05260021  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  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Australia
Brazil
France
India
Israel
Italy
Mexico
Russian Federation
Spain
United Kingdom
United States of America  
Sites of Study  
No of Sites = 6  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rajesh Khadgawat  All India Institute of Medical Sciences  Biotech Building, 3rd Floor, Room N0-303, All India Institute of Medical Sciences, Ansari Nagar, New Dehli -110029
New Delhi
DELHI 		 919891418190

rajeshkhadgawat@hotmail.com 
Dr Ameya Joshi  Bhaktivedanta Hospital & Research Institute  Shrishti Complex, Opp. To ISKCON, Bhaktivedanta Swami Marg, Mira Road (East), Thane- 401107
Thane
MAHARASHTRA 		 8879463725

ameyaable@gmail.com 
Dr Parag Shah  Gujarat Endocrine Center  2nd Floor, Silver Brook B, Opposite Doctor House, Nr. Parimal Crossing, Ahmedabad, Gujarat - 380006
Ahmadabad
GUJARAT 		 9824042688

paragendo@gmail.com 
Dr Balamurugan Ramanathan  Kovai Diabetes Speciality Centre & Hospital  #15, Vivekananda Road, Ram Nagar, Coimbatore - 641009, Tamil Nadu
Coimbatore
TAMIL NADU 		 9842244881

rbmkdsc@gmail.com 
Dr Chitra Selvan  M S Ramaiah Medical College and Hospitals  MSRIT Port, M S Ramaiah Nagar, Bangalore 560054
Bangalore
KARNATAKA 		 08040502983

chitraselvan@gmail.com 
Dr Soham Mukherjee  Post Graduate Institute of Medical Education and Research (PGIMER)  Nehru Extension Block, Department of Endocrinology Post Graduate Institute of Medical Education and Research, PGIMER Chandigarh-160012 U.T (INDIA)
Chandigarh
CHANDIGARH 		 9914278333

drsoham.mukherjee@googlemail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
Bhaktivedanta Hospital Ethics Committee  Approved 
Ethics Committee, M S Ramaiah Medical College and Hospitals  Approved 
Institute Ethics Committee, AIIMS  Approved 
Institutional Ethic Committee, PGIMER  Approved 
Institutional Ethics Committee of Kovai Diabetes Speciality Centre & Hospital  Approved 
Sangini Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo  0.5mL of placebo injected subcutaneously every week for 52 weeks. The study will last about 60 weeks. 
Intervention  Tirzepatide  2.5mg Tirzepatide injected subcutaneously weekly, then increase by 2.5mg every four weeks until maintenance dose level 1 (5mg) and level 2 (10mg) is reached, for 52 weeks. The study will last about 60 weeks. 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  1. Male or female, aged 10 to below 18 years at screening visit
2. Have type 2 diabetes, treated with diet and exercise and metformin and/or basal insulin. Metformin and/or basal insulin dose must be stable for at least 90 days prior to study screening.
3. Have HbA1c >6.5% to ≤11% at screening
4. Have body weight ≥50 kilogram (kg) 110 pounds and BMI of >85th percentile of the general age and gender-matched population for that country or region. 
 
ExclusionCriteria 
Details  1. Have Type 1 diabetes mellitus (T1DM), or positive GAD65 or IA2 antibodies.
2. After the T2DM diagnosis, have a history of diabetic ketoacidosis or hyperosmolar syndrome.
3. Have had ≥1 episode of severe hypoglycemia and/or ≥1 episode of hypoglycemic unawareness within the last 6 months.
4. Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2).
5. Had chronic or acute pancreatitis any time prior to study entry.
6. Female participants who are pregnant or breast feeding or intending to become pregnant.
7. Using prescription or over the counter medications for weight loss within 90 days of the screening visit. 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Centralized 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Change From Baseline in Hemoglobin A1c (HbA1c).  Baseline, Week 30 
 
Secondary Outcome  
Outcome  TimePoints 
1. Change from Baseline in HbA1c (Individual Doses).
2. Change From Baseline in Body Mass Index (BMI) Standard Deviation Score (age and sex-matched).
3. Change From Baseline in Fasting Serum Glucose (FSG).
4. Change From Baseline for Serum Lipid Levels.
5. Change From Baseline in Height Standard Deviation Score (SDS).
6. Change From Baseline in Weight SDS. 		 Baseline, Week 30 
1. Percentage of Participants Who Achieve ≤6.5% of HbA1c.
2. Percentage of Participants Who Achieve less than 7.0% of HbA1c.
3. Percentage of Participants Who Achieve less than 5.7% of HbA1c. 		 Week 30 
Pharmacokinetics (PK): Area Under the Concentration Curve (AUC), Steady State (ss) of Tirzepatide  Baseline to Week 30 
1. Change From Baseline in PedsQL Generic Core Scale.
2. Change From Baseline PedsQL (3.2) Diabetic Module 		 Baseline, Week 52 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "99"
Final Enrollment numbers achieved (India)="6" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   31/08/2022 
Date of Study Completion (India) 25/01/2025 
Date of First Enrollment (Global)  13/04/2022 
Date of Study Completion (Global) 28/01/2025 
Estimated Duration of Trial   Years="4"
Months="1"
Days="16" 
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 01-10-2022 and end date provided 31-03-2023?
    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 purpose of this study is to learn more about the safety and efficacy of tirzepatide compared to placebo in children or teenagers with type 2 diabetes taking metformin, or basal insulin, or both. The overall study will last about 60 weeks with up to 14 clinic visits and 6 phone visits. Clinic visits will include blood sample collection, physical exam and questionnaire.

 
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