| CTRI Number |
CTRI/2025/12/098644 [Registered on: 08/12/2025] Trial Registered Prospectively |
| Last Modified On: |
05/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Study of the effect of tirzepatide on weight and metabolic parameters in patients of Obesity with and without Diabetes mellitus |
|
Scientific Title of Study
|
Efficacy and safety of tirzepatide – a twincretin on weight and metabolic parameters in patients of Obesity with and without Diabetes mellitus |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shruti Chandra |
| Designation |
Associate Professor |
| Affiliation |
MGM Medical College & Hospital |
| Address |
N 6 CIDKO Aurangabad
N 6 CIDKO AURANAGABAD
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
09975336706 |
| Fax |
|
| Email |
dr.shruti1204@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jyoti Bobde |
| Designation |
Professor |
| Affiliation |
MGM Medical college & Hospital |
| Address |
Department of Pharmacology
Mgm Medical college & Hospital
N 6 CIDKO Aurangabad
N 6 CIDKO Aurangabad
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
09975336706 |
| Fax |
|
| Email |
jyobobde@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shruti Chandra |
| Designation |
Associate Professor |
| Affiliation |
MGM Medical College & Hospital |
| Address |
Department of Pharmacology
Mgm Medical college & Hospital
N 6 CIDKO Aurangabad
N 6 CIDKO AURANAGABAD
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
09975336706 |
| Fax |
|
| Email |
dr.shruti1204@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mgm Medical college & Hospital
|
|
|
Primary Sponsor
|
| Name |
Dr Shruti chandra |
| Address |
Department of Pharmacology
Mgm Medical college & Hospital
N 6 CIDKO Aurangabad |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shruti Chandra |
Deogiri Diabetes centre |
Kalda corner Aurangabad
431005
Aurangabad
MAHARASHTRA |
09975336706
dr.shruti1204@gmail.com |
| Dr Shruti Chandra |
MGM Medical college and Hospital |
N 6 CIDKO Aurangabad
431003
Aurangabad
MAHARASHTRA |
09975336706
dr.shruti1204@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee for Research on Human Subjects |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E669||Obesity, unspecified, (2) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Tirzepatide |
Patients of obesity will be given tirzepatide 2.5 mg sc which will be escalated up to 10 mg sc as per tolerability |
| Intervention |
Tirzepetide |
Patients of obesity with diabetes mellitus will be given tirzepatide 2.5 mg sc which will be escalated up to 10 mg sc as per tolerability |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
Patient of either gender between ages group 18 to 65 years
Individual with BMI more than 25 kg per m square
Patient is willing to participate in the study and give written informed consent
Patient with or without type 2 DM
|
|
| ExclusionCriteria |
| Details |
Patient having thyroid dysfunction
Patients taking concurrent medications known to cause weight gain or weight loss
Patient has a history of UTI and recurrent genitourinary infection
Patient having renal and hepatic impairment
Patient showing intolerance to tirzepatide
Pregnant and Lactating women
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to assess the efficacy of tirzepatide on anthropometric parameters like weight BMI and waist circumference |
zero 6 12 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the demographic profile in patients of Obesity with and without Diabetes mellitus |
zero month |
| To assess the efficacy of tirzepatide on glycemic parameters like FBS and HbA1c levels and insulin resistance HOMA IR |
zero 6 12 month |
| To assess the efficacy of tirzepatide on lipid profile parameters Serum Cholesterol serum Triglyceride LDLC HDLC |
zero 6 12 month |
| To assess the efficacy of tirzepatide on serum transaminase level |
zero 6 12 month |
| to assess the effect of tirzepatide on FIB 4 Score and NFS Score |
zero 6 12 month |
| To assess the safety of tirzepatide in patients of Obesity with and without Diabetes mellitus as per the patient |
zero 6 12 month |
|
|
Target Sample Size
|
Total Sample Size="78"
Sample Size from India="78"
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
|
N/A |
|
Date of First Enrollment (India)
|
16/12/2025 |
| 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="2"
Months="0"
Days="0" |
|
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 - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dr.shruti1204@gmail.com].
- For how long will this data be available start date provided 01-12-2025 and end date provided 01-12-2030?
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
|
The study evaluates the efficacy and safety of tirzepatide, a dual GIP and GLP 1 receptor agonist, in patients of obesity with and without type 2 diabetes. Obesity is highly prevalent in India and contributes to major metabolic diseases. The prospective, open-label, interventional trial includes 78 participants assessing changes in weight, BMI, waist circumference, glycemic parameters, lipid profile, liver enzymes, and insulin resistance over 12 months. Participants will receive weekly tirzepatide injections with follow-up at 6 and 12 months. The study aims to generate population-specific evidence to support personalized obesity management and improve metabolic outcomes in Indian patients. |