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CTRI Number  CTRI/2024/10/075299 [Registered on: 15/10/2024] Trial Registered Prospectively
Last Modified On: 28/11/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   REIMAGINE 5: A research study to see how much CagriSema (1.0 mg once weekly) lowers blood sugar and body weight compared to tirzepatide (5 mg once weekly) in people with type 2 diabetes treated with metformin, SGLT2 inhibitor or both 
Scientific Title of Study   Efficacy and safety of co-administered cagrilintide and semaglutide (CagriSema) 1.0 mg/1.0 mg s.c. once weekly versus tirzepatide 5 mg s.c. once weekly in participants with type 2 diabetes inadequately controlled on metformin, SGLT2 inhibitor or both 
Trial Acronym  REIMAGINE 5 
Secondary IDs if Any  
Secondary ID  Identifier 
155796  Other 
2023-509600-15  EudraCT 
NN9388-7741 Version 1.0 dated 05 Feb 2024  Protocol Number 
U1111-1300-2590   UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query  
Name  Dr Maya Sharma 
Designation  Vice President - Clinical, Medical, Regulatory and Pharmacovigilance 
Affiliation  Novo Nordisk India Private  
Address  Novo Nordisk India Private Limited Nxt Tower-2, Floor 1 & 2, Embassy Manyata Business Park, Nagavara Village, Kasaba Hobli, Bangalore-560 045 Karnataka, India

Bangalore
KARNATAKA
560045
India 
Phone  09911497869  
Fax  080-41123518  
Email  yrms@novonordisk.com  
 
Details of Contact Person
Public Query  
Name  Dr Maya Sharma 
Designation  Vice President - Clinical, Medical, Regulatory and Pharmacovigilance 
Affiliation  Novo Nordisk India Private  
Address  Novo Nordisk India Private Limited Nxt Tower-2, Floor 1 & 2, Embassy Manyata Business Park, Nagavara Village, Kasaba Hobli, Bangalore-560 045 Karnataka, India


KARNATAKA
560045
India 
Phone  09911497869  
Fax  080-41123518  
Email  yrms@novonordisk.com  
 
Source of Monetary or Material Support
Modification(s)  
Novo Nordisk AS Novo Allé, 2880 Bagsvaerd Denmark  
 
Primary Sponsor
Modification(s)  
Name  Novo Nordisk India Private Limited 
Address  Nxt Tower - 2, Floor 1 and 2, Embassy Manyata Business Park, Nagavara Village, Kasaba Hobli, Bangalore - 560045. India  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Argentina
Australia
Brazil
Canada
Germany
Greece
Hungary
India
Israel
Poland
Romania
Spain
Taiwan
United States of America  
Sites of Study
Modification(s)  
No of Sites = 13  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shilpa Bawankule  Acharya Vinoba Bhave Rural Hospital  Department of Medicine, Sawangi Meghe, Wardha Datta Meghe Institute of Higher Education & Research, Wardha, Maharashtra – 442001, India
Wardha
MAHARASHTRA 		 9673288822

drshilpagaidhane@gmail.com 
Dr Abhishek Katakwar   AIG Hospitals  Tower-B, Clinical Research Department, 5th floor, Beside Mindspace Road, Gachibowli,Hyderabad-500032,Telegana,India
Hyderabad
TELANGANA 		 8087358725

abhishekkatakwar@gmail.com 
Dr Yashdeep Gupta  All India Institute of Medical Sciences  Department of Endocrinology and Metabolism, Ansari Nagar, New Delhi- 110029
East
DELHI 		 9958615993

yash_deep_gupta@yahoo.co.in 
Dr Asirvatham  Arthur Asirvatham Hospital  Ground floor, Clinical research department, Arthur Asirvatham Hospital, No:42-A, Kuruvikaran Salai, Madurai, Tamil Nadu - 625 020
Madurai
TAMIL NADU 		 9443751977

ajasirvathamresearch@yahoo.in 
Dr Surendra Kumar Sharma  Diabetes, Thyroid and Endocrine Centre  Department of Endocrinology, A-1, Madrampura, Near 4 no. ESI Hospital,Ajmer Road, Sodala Jaipur-302006
Jaipur
RAJASTHAN 		 9829010233

sksharmacr@gmail.com 
Dr Kongara Srikanth  Endolife Specialty Hospitals Pvt. Ltd.  Department of Endocrinology D. No. 12-12-94, Old Club Road, Kothapet, Andhra Pradesh, Guntur -522001
Guntur
ANDHRA PRADESH 		 8185052052

srikanthendo@gmail.com 
Dr Sharvil Gadve  Excel Endocrine Centre  Excel Endocrine Centre, Diabetes Corner, Department of Endocrinology, 1758, E ward 4th Lane, Rajarampuri, Kolhapur, Maharashtra - 416008
Kolhapur
MAHARASHTRA 		 9552365977

sharvilgadve@gmail.com 
Dr Sujoy Ghosh  IPGME and R and SSKM Hospital  IPGMER and SSKM HOSPITAL, Department of Endocrinology,244,AJC BOSE ROAD, RONALD ROSS BUILDING, 3rd Floor, KOLKATA-700020
Kolkata
WEST BENGAL 		 9674625823

drsujoyghosh2000@gmail.com 
Dr Sanjeev Maheswari  Jawahar Lal Nehru Govt. Medical College  Clinical Research Department, Medicine College Building, Kala Bagh, Ajmer, Rajasthan- 305001, India
Ajmer
RAJASTHAN 		 9346950050

dr.sanjivmaheshwari@gmail.com 
Dr Dukhabandhu Naik  Jawaharlal Institute of Postgraduate Medical Education and Research  Department of Endocrinology, IPMER Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry - 605006
Pondicherry
PONDICHERRY 		 9843671306

drnaik2000@gmail.com 
Dr Pramila Kalra  M S Ramiah medical college and hospital  M S Ramaiah Medical College and Hospitals, M S Ramaiah Nagar, MSRIT Post, Bangalore-560054, Karnataka, India
Bangalore
KARNATAKA 		 9243257161

kalrapramila@gmail.com 
Dr Abhishek Agrawal  SMS Hospital  Department of Medicine G-1 Dhanvantri OPD Block SMS Hospital Jaipur-302004, Rajasthan
Jaipur
RAJASTHAN 		 9829298691

drabhie@yahoo.com 
Dr Mukulesh Gupta  Udyaan Healthcare Pvt Ltd  Department of Medicine,730, Udyan-1, Eldeco, Near Bangla Bazar, Lucknow 226012
Lucknow
UTTAR PRADESH 		 9336046146

drmukuleshgupta@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 13  
Name of Committee  Approval Status 
Ethics Committee  Approved 
Ethics Committee  Approved 
Excel Endocrine Centre Institutional Ethics Committee  Approved 
Human Welfare Ethical Committee for Human Sciences and Research  Approved 
Insititutional Ethics Committee of Endolife speciality hospitals private limited.  Approved 
Institute Ethics Committee  Approved 
Institutional Ethics committee  Approved 
Institutional Ethics committee  Approved 
Institutional Ethics committee  Approved 
Institutional Ethics committee  Approved 
Institutional Ethics Committee of DMIHER  Approved 
IPGME and R Research Oversight Commitee  Approved 
The Institutional Human Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E11||Type 2 diabetes mellitus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  CagriSema 1.0 mg/ 1.0 mg  It is an IMP, test product. The route of administration is Subcutaneous. Injections should be administered in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. It is recommended to avoid injecting at the same spot each time. The IMP should be injected once weekly on the same day of the week throughout the treatment period on the participant’s preferred dosing day. Labelled and packaged by Novo Nordisk A/S 
Comparator Agent  Tirzepatide 5 mg  Tirzepatide, Mounjaro®a pen is a IMP, reference therapy administered subcutaneously.Injections should be administered in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. It is recommended to avoid injecting at the same spot each time. The IMP should be injected once weekly on the same day of the week throughout the treatment period on the participant’s preferred dosing day. Labelled and packaged by Novo Nordisk A/S 
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Participants are eligible to be included in the study only if all the following criteria apply:

1. Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
2. Male or female.
3. Age 18 years or above at the time of signing the informed consent.
4. Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days before screening.
5. Stable daily dose(s) greater than or equal to 90 days before screening of any of the following antidiabetic drug(s) or
combination regimen(s) at effective or maximum tolerated dose as judged by the investigator:
- Metformin
- SGLT2 inhibitor
6. HbA1c 7.0-10.5percent (53-91 mmol per mol) (both inclusive) as determined by central laboratory at
screening.
7. BMI greater than or equal to 30 kg per m2 at screening. BMI will be calculated in the eCRF based on height and body weight at screening. 
 
ExclusionCriteria 
Details  Participants are excluded from the study if any of the following criteria apply:
Diabetes- or weight-related:
1. Renal impairment with estimated Glomerular Filtration Rate < 30 mL/min/1.73 m2 as
determined by central laboratory at screening.
2. Treatment with any anti-diabetic or anti-obesity medication (irrespective of indication) other
than stated in the inclusion criteria within 90 days before screening. However, short term insulin
treatment for a maximum of 14 consecutive days is allowed.
3. Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus
examination performed within 90 days before screening or in the period between screening and
randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus
photography camera specified for non-dilated examination.
4. Planned initiation or change in concomitant medications (for more than 14 consecutive days)
known to affect weight or glucose metabolism (e.g., treatment with thyroid hormones or
systemic corticosteroids).
5. Previous or planned (during the study period) obesity treatment with surgery or a weight loss
device. However, the following are allowed: (1) liposuction and/or abdominoplasty, if
performed > 1 year before screening, (2) lap banding, if the band has been removed > 1 year
before screening, (3) intragastric balloon, if the balloon has been removed > 1 year before
screening or (4) duodenal-jejunal bypass sleeve, if the sleeve has been removed > 1 year before
screening.
6. A self-reported change in body weight > 5% within 90 days before screening irrespective of
medical records.

General safety:
7. Known or suspected hypersensitivity to investigational medicinal product(s) or related products.
8. Previous randomisation in this study.
9. Previous rescreening in this study.
10. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing
potential and not using a highly effective contraceptive method.
11. Participation (i.e., signed informed consent) in any other interventional clinical study within 60 days before screening.
12. History of chronic pancreatitis.
13. Acute pancreatitis within 180 days before screening.
14. Any disorder which in the investigator’s opinion might jeopardise the participant’s safety or compliance with the protocol.
15. Planned major change in lifestyle (e.g., eating, exercise or sleeping pattern) during the study, as per investigator discretion.
16. Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary
thyroid carcinoma.
17. Myocardial infarction, stroke, transient ischaemic attack or hospitalization for unstable angina pectoris within 180 days before screening.
18. Chronic heart failure classified as being in New York Heart Association (NYHA) Class IV at
screening.
19. Planned coronary, carotid or peripheral artery revascularisation.
20. Presence or history of malignant neoplasms or in situ carcinomas (other than basal or squamous
cell skin cancer, low-risk prostate cancer, or in-situ carcinomas of the cervix or carcinoma in
situ/high grade prostatic intraepithelial neoplasia (PIN)) within 5 years before screening.
21. Use of any medication with unknown or unspecified content within 90 days before screening. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Change in HbA1c
2.Relative change in body
weight 		 1.From baseline (week 0) to end of treatment (week 60)
2.From baseline (week 0) to end of treatment(week 60) 
 
Secondary Outcome  
Outcome  TimePoints 
To confirm superiority of CagriSema
1.0 mg per 1.0 mg versus tirzepatide 5 mg
on change in HbA1c 		 From baseline
(week 0) to end of
treatment (week 60) 
To compare the safety and tolerability
of CagriSema 1.0 mg per 1.0 mg versus
tirzepatide 5 mg 		 From baseline
(week 0) to end of
study (week 66) 
 
Target Sample Size   Total Sample Size="1428"
Sample Size from India="100" 
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)   05/11/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  05/11/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="11"
Days="1" 
Recruitment Status of Trial (Global)
Modification(s)  		 Closed to Recruitment of Participants 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

This study aims to compare the effectiveness, safety, and tolerability of CagriSema 1.0 mg/1.0 mg, the lowest maintenance dose under assessment, with tirzepatide at its lowest maintenance dose of 5 mg in participants with type 2 diabetes inadequately controlled on metformin, SGLT2 inhibitor, or both. The study will provide complementary data to the high-dose REIMAGINE 4 NN9388-4894 study and other phase 3a clinical trials for the CagriSema indication of T2D. Two primary efficacy measures, change in HbA1c and relative change in body weight, will be evaluated in line with current clinical care guidelines for T2D, emphasizing the significance of glycemic control and weight management. The study period includes a screening phase of up to 3 weeks, a 60-week intervention period, and a 6-week follow-up period.


 
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