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CTRI Number  CTRI/2023/04/051486 [Registered on: 11/04/2023] Trial Registered Prospectively
Last Modified On: 27/06/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A research study to see how well CagriSema helps people with type 2 diabetes and excess body weight lose weight 
Scientific Title of Study   Efficacy and safety of cagrilintide s.c. 2.4 mg in combination with semaglutide s.c. 2.4 mg (CagriSema s.c. 2.4 mg/2.4 mg) once-weekly in participants with overweight or obesity and type 2 diabetes 
Trial Acronym   
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
2021-005121-24  EudraCT 
NCT05394519  ClinicalTrials.gov 
NN9838-4609 Version 7.0, 13 Oct 2023  Protocol Number 
U1111-1267-4287  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
Modification(s)  
Name  Dr Maya Sharma 
Designation  Vice President - Clinical, Medical, Regulatory & Pharmacovigilance 
Affiliation  Novo Nordisk India Private Ltd 
Address  Novo Nordisk India Private Limited, Nxt Tower - 2, Floor 1 & 2 Embassy Manyata Business Park, Nagavara Village, Kasaba Hobli, Bangalore - 560045. India

Bangalore
KARNATAKA
560045
India 
Phone  9911497869  
Fax  080-41123518  
Email  yrms@novonordisk.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Dr Maya Sharma 
Designation  Vice President - Clinical, Medical, Regulatory & Pharmacovigilance 
Affiliation  Novo Nordisk India Private Ltd 
Address  Novo Nordisk India Private Limited, Nxt Tower - 2, Floor 1 & 2 Embassy Manyata Business Park, Nagavara Village, Kasaba Hobli, Bangalore - 560045. India

Bangalore
KARNATAKA
560045
India 
Phone  9911497869  
Fax  080-41123518  
Email  yrms@novonordisk.com  
 
Source of Monetary or Material Support
Modification(s)  
Novo Nordisk India Private Limited, Nxt Tower - 2, Floor 1 & 2 Embassy Manyata Business Park, Nagavara Village, Kasaba Hobli, Bangalore - 560045. India  
 
Primary Sponsor  
Name  Novo Nordisk AS 
Address  Novo Nordisk A/S-Novo Allé, 2880 Bagsvaerd Denmark. 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     Austria
Canada
Germany
Hungary
India
Ireland
Japan
Malaysia
Poland
Russian Federation
Thailand
United Kingdom
United States of America  
Sites of Study
Modification(s)  
No of Sites = 16  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Tirthankar Chaudhury  Apollo Multispecialty Hospitals Limited  Apollo Multispecialty Hospitals, Limited 58, Canal Circular Road Kolkata 700054
Kolkata
WEST BENGAL 		 9831322394

tirthankarc05@gmail.com 
Dr Yashdeep Gupta   All India Institute of Medical Sciences  Ab 6 ward, 6th floor, seminar room, All India Institute of medical sciences (AIIMS), Ansari Nagar East, New Delhi, 110029
New Delhi
DELHI 		 9999598468

yash_deep_gupta@yahoo.co.in 
Dr Sharvil Gadve   Excel Endocrine Centre   Excel Endocrine Centre,4th Lane Rajarampuri,Kolhapur 416008.
Kolhapur
MAHARASHTRA 		 9552365977

sharvilgadve@gmail.com 
Dr Nikhil Bhagwat  BYL Nair Hospital and T N Medical College Department of endo  Department Of Endocrinology, College Building, 4th Floor, Department # :419, Topiwala National Medical College And B.Y.L.Nair Charitable Hospital, Dr.A.L.Nair Road, Mumbai - 400 008
Mumbai
MAHARASHTRA 		 9820238399

bhagwatnik@yahoo.co.in 
Dr Sunil Gupta  Dr Sunil Gupta  Sunils Diabetes Care n Research Centre 42, Lendra Park, Ramdaspeth, Nagpur 440010 
Nagpur
MAHARASHTRA 		 9823152111

drsgupta_ngp@rediffmail.com 
Dr A Lakshmi Lavanya  Gleneagles Hospital  Gleneagles Hospital 6-1-1040/1 to 4, Lakdikapul, Hyderabad, Telangana 500004
Hyderabad
TELANGANA 		 9000192233

drlakshmi.global19@gmail.com 
Dr Chandni R  Government Medical College  Government Medical College, Kozhikode,Mavoor road, Medical College Junction 17, Kozhikode, 673008, Kerala, India
Kozhikode
KERALA 		 9447202748

drchandni2019@gmail.com 
DrTiven Marwah  HCG Hospitals  HCG Hospitals Mithakhali Elisbridge Ahmedabad Gujarat-380006
Ahmadabad
GUJARAT 		 9824055857

tiven.marwah@gmail.com 
Dr P K Jabbar  Indian Institute of Diabetes,  Indian Institute of Diabetes, Pulayanarkotta, Thiruvananthapuram-695031, Kerala.
Thiruvananthapuram
KERALA 		 9446828766

drjabbar10@gmail.com 
Dr Anupam Prakash  Lady Hardinge Medical College and S.S.K. Hospital  Room No. 1014, Dept. of Medicine, Lady Hardinge Medical College and S.S.K. Hospital, Shaheed Bhagat Singh Marg, New Delhi- 110001
New Delhi
DELHI 		 8588885305

prakashanupam@hotmail.com 
Dr Chitra Selvan  M S Ramaiah Medical College and Hospitals  Department of endocrinology M S Ramaiah Medical College and Hospitals, M S Ramaiah Nagar,MSRIT Post,Bangalore 560054
Bangalore
KARNATAKA 		 8197132111

chitraselvan@gmail.com 
Dr V Mohan  Madras Diabetes Research Foundation  Madras Diabetes Research Foundation #4 Conran Smith Road, Gopalapuram, Chennai 600 086, India
Chennai
TAMIL NADU 		 9840134505

drmohans@diabetes.ind.in 
Dr Reema Kashiva  Noble Hospital Private LTD.   Noble Hospital Pvt. Ltd., 153 magarpatta City Road, Hadapsar, Pune 411013
Pune
MAHARASHTRA 		 9922618286

reemakashiva@gmail.com 
Dr Sanjay Bhadada  Post Graduate Institute of medical education and research  Department of Endocrinology Post Graduate Institute of Medical Education and Research Madhya Marg Sector 12 Chandigarh 160012 India
Chandigarh
CHANDIGARH 		 9876602448

bhadadask@rediffmail.com 
Dr Balaram Sharma  S M S Medical College & Hospital   Department of Endocrinology Room No 42 Forth Floor Dhanvantri OPD Block SMS Hospital Jaipur 302004
Jaipur
RAJASTHAN 		 09660226666

drbalramendo@gmail.com 
Dr Anurag Ranjan Lila  Seth G.S. Medical College & KEM Hospital  Seth G.S. Medical College & KEM Hospital Parel, Mumbai 400012
Mumbai
MAHARASHTRA 		 9323065346

anuraglila@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 16  
Name of Committee  Approval Status 
 Ethics Committee SMS Medical College and Attached Hospitals JLN Marg Jaipur Rajasthan 302004  Approved 
 Excel Endocrine Institutional Ethics Committee 1758 E Ward 4th Lane Rajarampuri Kolhapur 416008.  Approved 
 Institute Ethics Committee Room no 102 First Floor Old OT Block AIIMS Ansari Nagar New Delhi 110029  Approved 
 Noble Hospital Institutional Ethics Committee Basement Noble Annex  Noble Hospital Pvt Ltd 153 magarpatta City Road Hadapsar, Pune 411013  Approved 
 Seth GS Medical College and KEM Hospital New UG/PG Hostel 20th Storey Hostel Building Ground Floor KEM Hospital Campus Near Main Boys Hostel Dr S S Rao Marg Parel Mumbai 400012  Approved 
Ethics Committee, MS Ramaiah Medical College Hosp, M S Ramaiah Medical College And Hospitals M S Ramaiah Nagar MSRIT Post Bengaluru Bengaluru (Bangalore) Urban Karnataka 560054 India  Approved 
HCG Multi Speciality Ethics Committee, HCG HosPitals Mithakali Ellisbridge Ahmedabad Ahmedabad Gujarat - 380006 lndia  Approved 
IEC of Madras Diabetes Research Foundation 4 Conran Smith Road Gopalapuram Chennai Tamilnadu 600086  Approved 
Independent Ethics Committee of Diabetes Care Foundation of India Dhantoli, Nagpur 440012 Maharashtra India  Approved 
Institutional Ethics Committee Apollo Multispecialty Hospitals Limited 58 Canal Circular Road Kolkata 700054  Approved 
Institutional Ethics Committee Gleneagles Global Hospitals  Approved 
Institutional Ethics Committee Government Medical College Kozhikode Room No 1 and 2 Ground floor Lecture Theatre Complex Medical College Campus Medical College P 0 Calicut 673008 Kerala  Approved 
Institutional Ethics Committee Indian Institute of Diabetes Pulayanarkotta Thiruvananthapuram 695031 Kerala  Approved 
Institutional Ethics Committee Room No. 6006 IEC Office 6th Floor P N Chuttani Block Post Graduate Institute of Medical Education and Research Madhya Marg Sector 12 Chandigarh 160012 India  Approved 
Institutional Ethics Committee TNMC NAIR HOSPITAL  Approved 
LHMC Institutional Ethics Committee Lady Hardinge Medical College and Ass Hospitals Shaheed Bhagat Singh Marg Opposite Shivajii Stadium New Delhi New Delhi Delhi 110001 India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E669||Obesity, unspecified, (2) ICD-10 Condition: E11||Type 2 diabetes mellitus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  CagriSema  Drug: Cagrilintide administered subcutaneously (s.c., under the skin) once-weekly Drug: Semaglutide administered subcutaneously (s.c., under the skin) once-weekly. Total duration is 68 weeks.  
Comparator Agent  Placebo  Drug: Placebo cagrilintide administered subcutaneously (s.c., under the skin) once-weekly Drug: Placebo semaglutide administered subcutaneously (s.c., under the skin) once-weekly. Total duration is 68 weeks  
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1.Male or female
2.Age above or equal to 18 years at the time of signing informed consent
3. BMI greather than or equal to 27.0 kg per m2
4. Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days before screening
5.Treatment with either lifestyle intervention, or treatment with 1-3 marketed oral antidiabetic drugs (OAD)s (metformin, α-glucosidase inhibitors (AGI), glinides, sodium-glucose co-transporter 2 inhibitor (SGLT2i), thiazolidinediones, or sulphonylureas (SU)s as a single agent or in combination) according to local label
6. Treatment with oral antidiabetic drugs should be stable (same drug(s), dose and dosing frequency) for at least 90 days before screening
7. HbA1c below or equal to 10% (86 mmol/mol) as measured by the central laboratory at screening 
 
ExclusionCriteria 
Details  1.Clinically significant or severe hypoglycaemia within 6 months before screening or history of hypoglycaemia unawareness.
2.Renal impairment with estimated glomerular filtration rate (eGFR) below 30 mL per min per 1.73 m2 (below 45 mL per min per 1.73 m2 in participants treated with SGLT2i), as measured by the central laboratory at screening.
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. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Relative change in body weight
2.Achievement of greater than or equal to 5percent
weight reduction 		 1.Time Frame:
From baseline (week 0) to end of treatment
(week 68)
2.Time Frame: From baseline
(week 0) to end of treatment (week 68) 
 
Secondary Outcome  
Outcome  TimePoints 
Achievement of more than or equal to 20 percent weight reduction  Time Frame: From baseline (week 0) to end of treatment (week 68) Count of participant 
Relative change in body weight   Time Frame: From baseline (week 0) to week 20,Measured in percentage. 
Change in waist circumference   Time Frame: From baseline (week 0) to end of treatment (week 68),Measured in cm 
Change in Glycated Haemoglobin (HbA1c)   Time Frame: From baseline (week 0) to end of treatment (week 68) percentage-points 
Change in Systolic Blood Pressure (SBP)   Time Frame: From baseline (week 0) to end of treatment (week 68),Measured in mmHg 
Change in Quality Of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function score   Time Frame: From baseline (week 0) to end of treatment (week 68) ,Score points 
Change in Short Form-36 Version 2.0 (SF-36v2) Physical Functioning score   Time Frame: From baseline (week 0) to end of treatment (week 68),Score points 
 
Target Sample Size   Total Sample Size="1200"
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)   24/05/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/11/2022 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="10"
Days="14" 
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 - NO
Brief Summary  

This study will look at how well the new medicine CagriSema helps people living with excess body weight and type 2 diabetes losing weight. Participants will either get CagriSema or a dummy medicine. Which treatment they get is decided by chance.

The study will last for about 1½ years. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period.

 
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